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Robot Assisted Virtual Rehabilitation for the Hand Post Stroke (RAVR) (RAVR)

Primary Purpose

Stroke, Acute

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Robotic/VR Therapy (EVR)
Dose-Matched Usual Physical Therapy Care
Delayed Robotic/VR Therapy (DVR)
Sponsored by
New Jersey Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Stroke, Virtual Environment, Robotics, Upper Extremity, Hand, Transcranial Magnetic Stimulation

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • unilateral right or left sided stroke within 7 to 30 days of starting study
  • sufficient cognitive function to follow instructions
  • Fugl-Meyer (FM) of ≤ 49/66
  • intact cutaneous sensation (e.g. ability to detect <4.17 N stimulation using Semmes- Weinstein nylon filaments

Exclusion Criteria:

  • prior stroke with persistent motor impairment or other disabling neurologic condition
  • non-independent before stroke
  • receptive aphasia
  • hemispatial neglect or severe proprioceptive loss
  • significant illnesses
  • severe arthritis that limits arm and hand movements
  • a score of ≥1 on the NIHSS limb ataxia item

Sites / Locations

  • Kessler Institute for RehabilitationRecruiting
  • Kessler Institute for Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

Experimental

Arm Label

Early Robotic/VR Therapy (EVR)

Delayed Robotic/VR Therapy (DVR)

Usual Physical Therapy Care

Dose-Matched Usual Physical Therapy Care

Arm Description

Subjects in this group will receive state-of-art inpatient usual care therapy plus 10 days of extra 1-hour/day of intensive therapy focusing on the hand using haptic robots integrated with complex gaming and virtual environments and initiated 5-30 days post stroke.

Subjects in this group will receive state-of-art usual care therapy (inpatient and outpatient) plus 10 days of extra 1-hour/day of intensive therapy focusing on the hand using haptic robots integrated with complex gaming and virtual environments and initiated within 31-60 days post stroke.

Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care.

Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care plus an extra hour of state-of-art usual care.

Outcomes

Primary Outcome Measures

Action Research Arm Test (ARAT)
The ARAT assesses upper extremity activity. It is a 19 item test divided into four subscales: grasp, grip, pinch and movement. Scores range from 0-57 with higher scores indicating better performance.

Secondary Outcome Measures

Action Research Arm Test
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Action Research Arm Test
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Action Research Arm Test
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Action Research Arm Test
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Cortical Area Representation of the Finger-Hand Muscles
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
Cortical Area Representation of the Finger-Hand Muscles
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
Cortical Area Representation of the Finger-Hand Muscles
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
Cortical Area Representation of the Finger-Hand Muscles
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
Cortical Area Representation of the Finger-Hand Muscles
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
EEG-Based Measure of Resting State Brain Connectivity
Electroencephalography will be used to evaluate resting-state brain connectivity.
EEG-Based Measure of Resting State Brain Connectivity
Electroencephalography will be used to evaluate resting-state brain connectivity.
EEG-Based Measure of Resting State Brain Connectivity
Electroencephalography will be used to evaluate resting-state brain connectivity.
EEG-Based Measure of Resting State Brain Connectivity
Electroencephalography will be used to evaluate resting-state brain connectivity.
EEG-Based Measure of Resting State Brain Connectivity
Electroencephalography will be used to evaluate resting-state brain connectivity.
EEG-Based Measure of Task-Based Brain Connectivity
Task-based connectivity will be evaluated.
EEG-Based Measure of Task-Based Brain Connectivity
Electroencephalography will be used to evaluate task-based brain connectivity.
EEG-Based Measure of Task-Based Brain Connectivity
Electroencephalography will be used to evaluate task-based brain connectivity.
EEG-Based Measure of Task-Based Brain Connectivity
Electroencephalography will be used to evaluate task-based brain connectivity.
EEG-Based Measure of Task-Based Brain Connectivity
Electroencephalography will be used to evaluate task-based brain connectivity.
Cerebral Oxygenation in Sensorimotor Cortex
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Cerebral Oxygenation in Sensorimotor Cortex
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Cerebral Oxygenation in Sensorimotor Cortex
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Cerebral Oxygenation in Sensorimotor Cortex
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Cerebral Oxygenation in Sensorimotor Cortex
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Blocks and Box Test
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Blocks and Box Test
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Blocks and Box Test
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Blocks and Box Test
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Blocks and Box Test
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Wolf Motor Function Test
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Wolf Motor Function Test
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Wolf Motor Function Test
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Wolf Motor Function Test
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Wolf Motor Function Test
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Coordination between Hand Transport and Grasp during Reaching
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Coordination between Hand Transport and Grasp during Reaching
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Coordination between Hand Transport and Grasp during Reaching
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Coordination between Hand Transport and Grasp during Reaching
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Coordination between Hand Transport and Grasp during Reaching
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Arm Range of Motion
Active range of motion for fingers, wrist, elbow and shoulder.
Arm Range of Motion
Active range of motion for fingers, wrist, elbow and shoulder.
Arm Range of Motion
Active range of motion for fingers, wrist, elbow and shoulder.
Arm Range of Motion
Active range of motion for fingers, wrist, elbow and shoulder.
Arm Range of Motion
Active range of motion for fingers, wrist, elbow and shoulder.
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Maximum Thumb and Index Fingertip Pinch Force
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Maximum Thumb and Index Fingertip Pinch Force
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Maximum Thumb and Index Fingertip Pinch Force
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Maximum Thumb and Index Fingertip Pinch Force
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Maximum Thumb and Index Fingertip Pinch Force
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Measurement of Daily Use of Upper Extremity
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
Measurement of Daily Use of Upper Extremity
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
Measurement of Daily Use of Upper Extremity
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
EuroQol
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
EuroQol
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
EuroQol
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
EuroQol
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
EuroQol
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
National Institutes of Health Stroke Scale (NIHSS)
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
National Institutes of Health Stroke Scale (NIHSS)
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
National Institutes of Health Stroke Scale (NIHSS)
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
National Institutes of Health Stroke Scale (NIHSS)
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
National Institutes of Health Stroke Scale (NIHSS)
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
Change in Robot-Based Measure of Elbow-Shoulder Coordination during Reaching
To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed every day immediately prior to VR training to measure changes in patterns of elbow-shoulder coordination.
Change in Robot-Based Measure of Maximum Seated Workspace during Reaching
To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed every day immediately prior to VR training to measure changes in maximum seated workspace.
Change in Robot-Based Measure of Movement Speed during Arm Reaching
To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed immediately prior to VR training to measure changes in arm speed during reaching for a virtual target.
Change in Robot-Based Measure of Movement Speed during Targeted Finger Motion
To compare the immediate effects of training in the EVR and DVR groups, subjects will perform targeted finger movements in a virtual environment. The test will be performed every day immediately prior to VR training to measure changes in the speed of finger movement towards a virtual target.
Patient's Structured Subjective Assessment
This is a 27 item questionnaire that addresses the subjects perception of the function of their hemiplegic arm and the effect this intervention had on their hand function. Subjects fill out the questionnaire prior to and directly after the intervention. Some questions require a response such as disagree, neutral and agree, others require ordering their gaming activity preferences, or responding to a question with a short answer.

Full Information

First Posted
April 10, 2018
Last Updated
March 31, 2023
Sponsor
New Jersey Institute of Technology
Collaborators
Rutgers University, Northeastern University, Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03569059
Brief Title
Robot Assisted Virtual Rehabilitation for the Hand Post Stroke (RAVR)
Acronym
RAVR
Official Title
Optimizing Hand Rehabilitation Post Stroke Using Interactive Virtual Environments
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2018 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New Jersey Institute of Technology
Collaborators
Rutgers University, Northeastern University, Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study investigates the effects of intensive, high dosage task and impairment based training of the hemiparetic hand, using haptic robots integrated with complex gaming and virtual reality simulations. There is a time-limited period of post-ischemic heightened neuronal plasticity during which intensive training may optimally affect the recovery of motor skills, indicating that the timing of rehabilitation is as important as the dosing. However, recent literature indicates a controversy regarding both the value of intensive, high dosage as well as the optimal timing for therapy in the first two months after stroke. This study is designed to empirically investigate this controversy. It is evident that providing additional, intensive therapy during the acute rehabilitation stay is more complicated to implement and difficult for patients to tolerate, than initiating it in the outpatient setting, immediately after discharge. The robotic/VR system is specifically designed to deliver hand and arm training when motion and strength are limited, using adaptive algorithms to drive individual finger movement, gain adaptation and workspace modification to increase finger and arm range of motion, and haptic and visual feedback from mirrored movements to reinforce motor networks in the lesioned hemisphere.
Detailed Description
This study investigates the effects of high dosage task and impairment based training of the hemiparetic hand, using haptic robots integrated with complex gaming and virtual reality simulations on recovery and function of the hand, when the training is initiated within early period of heightened plasticity. The intervention uses two training systems. NJIT-RAVR consists of a data glove combined with the Haptic Master robot that provides tracking of movements in a 3D workspace and enables programmable haptic effects, such as variable anti-gravity support, springs and dampers, and various haptic objects. The NJIT-TrackGlove consists of a robotic hand exoskeleton to provide haptic effects or assistance and an instrumented glove for finger angle tracking, and an arm tracking system to track hand and arm position and orientation. Using programmable software and custom bracing we enable use of this system for patients with a broad set of impairments and functional abilities. A library of custom-designed impairment and task-based simulations that train arm transport and hand manipulation, together or separately will be used. Pilot data show that it is possible to integrate intensive, high-dosage, targeted hand therapy into the routine of an acute rehabilitation setting. The study integrates the behavioral, the kinematic/kinetic and neurophysiological aspects of recovery to determine: 1) whether early intensive training focusing on the hand will result in a more functional hemiparetic arm; (2) whether it is necessary to initiate intensive hand therapy during the very early inpatient rehabilitation phase or will comparable outcomes be achieved if the therapy is initiated right after discharge, in the outpatient period; and 3) whether the effect of the early intervention observed at 6 months post stroke can be predicted by the cortical reorganization evaluated immediately prior to the therapy. This study will fill critical gaps in the literature and make a significant advancement in the investigation of putative interventions for recovery of hand function in patients post-stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Stroke, Virtual Environment, Robotics, Upper Extremity, Hand, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of four groups in parallel for the duration of the study.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Robotic/VR Therapy (EVR)
Arm Type
Experimental
Arm Description
Subjects in this group will receive state-of-art inpatient usual care therapy plus 10 days of extra 1-hour/day of intensive therapy focusing on the hand using haptic robots integrated with complex gaming and virtual environments and initiated 5-30 days post stroke.
Arm Title
Delayed Robotic/VR Therapy (DVR)
Arm Type
Experimental
Arm Description
Subjects in this group will receive state-of-art usual care therapy (inpatient and outpatient) plus 10 days of extra 1-hour/day of intensive therapy focusing on the hand using haptic robots integrated with complex gaming and virtual environments and initiated within 31-60 days post stroke.
Arm Title
Usual Physical Therapy Care
Arm Type
No Intervention
Arm Description
Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care.
Arm Title
Dose-Matched Usual Physical Therapy Care
Arm Type
Experimental
Arm Description
Subjects in this group will receive state-of-art usual physical therapy/occupational therapy care plus an extra hour of state-of-art usual care.
Intervention Type
Device
Intervention Name(s)
Early Robotic/VR Therapy (EVR)
Other Intervention Name(s)
NJIT-RAVR, NJIT-TrackGlove
Intervention Description
Subjects will perform state-of-art inpatient usual care therapy. In addition, they will perform an extra 1-hour/day of intensive therapy focusing on the hand in the form of interactive virtual reality games while assisted by robots. This additional treatment will be initiated 5-30 days post stroke.
Intervention Type
Behavioral
Intervention Name(s)
Dose-Matched Usual Physical Therapy Care
Intervention Description
Subjects will perform state-of-art usual physical/occupational care and 10 days of one additional hour of state-of-art usual inpatient and/or outpatient physical therapy/occupational therapy.
Intervention Type
Device
Intervention Name(s)
Delayed Robotic/VR Therapy (DVR)
Other Intervention Name(s)
NJIT-RAVR, NJIT-TrackGlove
Intervention Description
Subjects will perform state-of-art inpatient usual care therapy. In addition, they will perform an extra 1-hour/day of intensive therapy focusing on the hand in the form of interactive virtual reality games while assisted by robots. This additional treatment will be initiated 31-60 days post stroke.
Primary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
The ARAT assesses upper extremity activity. It is a 19 item test divided into four subscales: grasp, grip, pinch and movement. Scores range from 0-57 with higher scores indicating better performance.
Time Frame
4 months post stroke
Secondary Outcome Measure Information:
Title
Action Research Arm Test
Description
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Time Frame
6 months post stroke
Title
Action Research Arm Test
Description
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Time Frame
1 month post treatment
Title
Action Research Arm Test
Description
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
Action Research Arm Test
Description
The ARAT assesses upper extremity activity. It is a 19 item test divided into four
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Cortical Area Representation of the Finger-Hand Muscles
Description
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
Time Frame
4 months post stroke
Title
Cortical Area Representation of the Finger-Hand Muscles
Description
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
Time Frame
6 months post stroke
Title
Cortical Area Representation of the Finger-Hand Muscles
Description
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
Time Frame
1 month post treatment
Title
Cortical Area Representation of the Finger-Hand Muscles
Description
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
Cortical Area Representation of the Finger-Hand Muscles
Description
Single-pulse transcranial magnetic stimulation will be used to assay patterns of corticospinal reorganization. Changes in the ipsilesional hand cortical territory for all subjects will be quantified using motor evoked potentials. The topographic representation of the hand and arm muscles will be mapped.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
EEG-Based Measure of Resting State Brain Connectivity
Description
Electroencephalography will be used to evaluate resting-state brain connectivity.
Time Frame
4 months post stroke
Title
EEG-Based Measure of Resting State Brain Connectivity
Description
Electroencephalography will be used to evaluate resting-state brain connectivity.
Time Frame
6 months post stroke
Title
EEG-Based Measure of Resting State Brain Connectivity
Description
Electroencephalography will be used to evaluate resting-state brain connectivity.
Time Frame
1 month post treatment
Title
EEG-Based Measure of Resting State Brain Connectivity
Description
Electroencephalography will be used to evaluate resting-state brain connectivity.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
EEG-Based Measure of Resting State Brain Connectivity
Description
Electroencephalography will be used to evaluate resting-state brain connectivity.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
EEG-Based Measure of Task-Based Brain Connectivity
Description
Task-based connectivity will be evaluated.
Time Frame
4 months post stroke
Title
EEG-Based Measure of Task-Based Brain Connectivity
Description
Electroencephalography will be used to evaluate task-based brain connectivity.
Time Frame
6 months post stroke
Title
EEG-Based Measure of Task-Based Brain Connectivity
Description
Electroencephalography will be used to evaluate task-based brain connectivity.
Time Frame
1 month post treatment
Title
EEG-Based Measure of Task-Based Brain Connectivity
Description
Electroencephalography will be used to evaluate task-based brain connectivity.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
EEG-Based Measure of Task-Based Brain Connectivity
Description
Electroencephalography will be used to evaluate task-based brain connectivity.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Cerebral Oxygenation in Sensorimotor Cortex
Description
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Time Frame
4 months post stroke
Title
Cerebral Oxygenation in Sensorimotor Cortex
Description
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Time Frame
6 months post stroke
Title
Cerebral Oxygenation in Sensorimotor Cortex
Description
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Time Frame
1 month post treatment
Title
Cerebral Oxygenation in Sensorimotor Cortex
Description
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
Cerebral Oxygenation in Sensorimotor Cortex
Description
Functional near-infrared spectroscopy will be used to quantify cerebral oxygenation in the sensorimotor cortex during a simple motor task.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Blocks and Box Test
Description
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Time Frame
4 months post stroke
Title
Blocks and Box Test
Description
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Time Frame
6 months post stroke
Title
Blocks and Box Test
Description
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Time Frame
1 month post treatment
Title
Blocks and Box Test
Description
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
Blocks and Box Test
Description
A unilateral test of manual dexterity scored as the maximum number of blocks that can be moved from one compartment of the box to another of equal size, within 60 seconds.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Description
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Time Frame
4 months post stroke
Title
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Description
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Time Frame
6 months post stroke
Title
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Description
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Time Frame
1 month post treatment
Title
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Description
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Description
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Wolf Motor Function Test
Description
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Time Frame
4 months post stroke
Title
Wolf Motor Function Test
Description
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Time Frame
6 months post stroke
Title
Wolf Motor Function Test
Description
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Time Frame
1 month post treatment
Title
Wolf Motor Function Test
Description
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
Wolf Motor Function Test
Description
A 15 item timed test of arm and hand use in patients post stroke. The items begin with simple proximal movements and progress to more complex distal hand movements.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Coordination between Hand Transport and Grasp during Reaching
Description
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Time Frame
4 months post stroke
Title
Coordination between Hand Transport and Grasp during Reaching
Description
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Time Frame
6 months post stroke
Title
Coordination between Hand Transport and Grasp during Reaching
Description
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Time Frame
1 month post treatment
Title
Coordination between Hand Transport and Grasp during Reaching
Description
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
Coordination between Hand Transport and Grasp during Reaching
Description
The real-world Reach-Grasp test measures the kinematics of everyday movements involving grasping and manipulating household objects. Kinematics of reaching for an object, lifting it from the support, transporting it to a predefined location and releasing the object will be evaluated. Coordination between hand transport and grasping will be evaluated by analyzing hand preshaping during reach.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Arm Range of Motion
Description
Active range of motion for fingers, wrist, elbow and shoulder.
Time Frame
4 months post stroke
Title
Arm Range of Motion
Description
Active range of motion for fingers, wrist, elbow and shoulder.
Time Frame
6 months post stroke
Title
Arm Range of Motion
Description
Active range of motion for fingers, wrist, elbow and shoulder.
Time Frame
1 month post treatment
Title
Arm Range of Motion
Description
Active range of motion for fingers, wrist, elbow and shoulder.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
Arm Range of Motion
Description
Active range of motion for fingers, wrist, elbow and shoulder.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Description
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Time Frame
4 months post stroke
Title
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Description
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Time Frame
6 months post stroke
Title
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Description
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Time Frame
1 month post treatment
Title
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Description
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
Accuracy of Tracking a Square and Sine Wave with Fingertip Pinch Force
Description
Ability to regulate force will be evaluated by measuring the accuracy of tracking square and sine waves presented on a computer screen. Vertical position of the cursor on the screen will be defined by isometric force between the thumb and index fingertips measured by a force sensor.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Maximum Thumb and Index Fingertip Pinch Force
Description
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Time Frame
4 months post stroke
Title
Maximum Thumb and Index Fingertip Pinch Force
Description
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Time Frame
6 months post stroke
Title
Maximum Thumb and Index Fingertip Pinch Force
Description
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Time Frame
1 month post treatment
Title
Maximum Thumb and Index Fingertip Pinch Force
Description
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
Maximum Thumb and Index Fingertip Pinch Force
Description
A force sensor will be used to measure in Newtons maximum isometric pinch force achieved between the thumb and index fingertips.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
Description
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Time Frame
4 months post stroke
Title
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
Description
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Time Frame
6 months post stroke
Title
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
Description
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Time Frame
1 month post treatment
Title
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
Description
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
Accuracy of Tracking a Square and Sine Wave with Isotonic Finger Flexion/Extension
Description
A data glove will be used to evaluate the accuracy of tracking square and sine waves presented on a computer screen with isotonic finger flexion/extension. Vertical position of the cursor on the screen will be defined by the average of four metacarpophalangeal finger joints.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Measurement of Daily Use of Upper Extremity
Description
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
Time Frame
4 months post stroke
Title
Measurement of Daily Use of Upper Extremity
Description
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
Time Frame
6 months post stroke
Title
Measurement of Daily Use of Upper Extremity
Description
Wearable sensors will be used to quantify daily use of the affected arm after the intervention.
Time Frame
1 month post treatment
Title
EuroQol
Description
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
Time Frame
4 months post stroke
Title
EuroQol
Description
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
Time Frame
6 months post stroke
Title
EuroQol
Description
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
Time Frame
1 month post treatment
Title
EuroQol
Description
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
EuroQol
Description
The EuroQol - EQ-5D is a standardized instrument used as a measure of health-related quality of life. The descriptive system comprises five dimensions: 1. mobility, the person's walking ability; 2. self-care, the ability to wash or dress by oneself; 3. usual activities dimension, performance in "work, study, housework, family or leisure activities"; 4. pain/discomfort, how much pain or discomfort they have, and 5. anxiety/depression, how much anxious or depressed they are. The respondents self-rate their level of severity for each dimension.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
Time Frame
4 months post stroke
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
Time Frame
6 months post stroke
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
Time Frame
1 month post treatment
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
Time Frame
Immediately post treatment (ideally within 72 hours)
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate and document neurological status in stroke patients and the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal.
Time Frame
Immediately prior to treatment (ideally within 72 hours)
Title
Change in Robot-Based Measure of Elbow-Shoulder Coordination during Reaching
Description
To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed every day immediately prior to VR training to measure changes in patterns of elbow-shoulder coordination.
Time Frame
Day 1 and and Day 10 of treatment for EVR and DVR groups
Title
Change in Robot-Based Measure of Maximum Seated Workspace during Reaching
Description
To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed every day immediately prior to VR training to measure changes in maximum seated workspace.
Time Frame
Day 1 and and Day 10 of treatment for EVR and DVR groups
Title
Change in Robot-Based Measure of Movement Speed during Arm Reaching
Description
To compare the immediate effects of training in the EVR and DVR groups, subjects will reach to five haptically rendered spheres located in a 3D virtual environment. The test will be performed immediately prior to VR training to measure changes in arm speed during reaching for a virtual target.
Time Frame
Day 1 and and Day 10 of treatment for EVR and DVR groups
Title
Change in Robot-Based Measure of Movement Speed during Targeted Finger Motion
Description
To compare the immediate effects of training in the EVR and DVR groups, subjects will perform targeted finger movements in a virtual environment. The test will be performed every day immediately prior to VR training to measure changes in the speed of finger movement towards a virtual target.
Time Frame
Day 1 and and Day 10 of treatment for EVR and DVR groups
Title
Patient's Structured Subjective Assessment
Description
This is a 27 item questionnaire that addresses the subjects perception of the function of their hemiplegic arm and the effect this intervention had on their hand function. Subjects fill out the questionnaire prior to and directly after the intervention. Some questions require a response such as disagree, neutral and agree, others require ordering their gaming activity preferences, or responding to a question with a short answer.
Time Frame
Immediately post treatment (ideally within 72 hours) for EVR and DVR groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unilateral right or left sided stroke within 7 to 30 days of starting study sufficient cognitive function to follow instructions Fugl-Meyer (FM) of ≤ 49/66 intact cutaneous sensation (e.g. ability to detect <4.17 N stimulation using Semmes- Weinstein nylon filaments Exclusion Criteria: prior stroke with persistent motor impairment or other disabling neurologic condition non-independent before stroke receptive aphasia hemispatial neglect or severe proprioceptive loss significant illnesses severe arthritis that limits arm and hand movements a score of ≥1 on the NIHSS limb ataxia item
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergei V Adamovich, PhD
Phone
973-596-3413
Email
sergei.adamovich@njit.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Kaplan, MS
Phone
973-243-6880
Email
EKaplan@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergei V Adamovich, PhD
Organizational Affiliation
New Jersey Institute of Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alma S Merians, PhD, PT
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Nolan, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugene Tunik, PhD, PT
Organizational Affiliation
Northeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Institute for Rehabilitation
City
Saddle Brook
State/Province
New Jersey
ZIP/Postal Code
07663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Barry, MS
Phone
973-324-3556
Email
MBarry@kesslerfoundation.org
Facility Name
Kessler Institute for Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Barry, MS
Phone
973-324-3556
Email
MBarry@kesslerfoundation.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33324323
Citation
Merians AS, Fluet GG, Qiu Q, Yarossi M, Patel J, Mont AJ, Saleh S, Nolan KJ, Barrett AM, Tunik E, Adamovich SV. Hand Focused Upper Extremity Rehabilitation in the Subacute Phase Post-stroke Using Interactive Virtual Environments. Front Neurol. 2020 Nov 26;11:573642. doi: 10.3389/fneur.2020.573642. eCollection 2020.
Results Reference
derived
Links:
URL
http://centers.njit.edu/rehabilitation/about-rerc/
Description
The web site describes the Center for Rehabilitation Robotics at NJIT where the technologies used in this study are being developed.

Learn more about this trial

Robot Assisted Virtual Rehabilitation for the Hand Post Stroke (RAVR)

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