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Neural Mechanisms of Motor Recovery With Technology Assisted Training

Primary Purpose

Hemiparesis, Stroke Sequelae

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
robot-assisted training
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemiparesis focused on measuring stroke, robot-assisted rehabilitation, neural networks, fnirs, rehabilitation

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 to 88 years
  • Able to provide informed consent based on Evaluation to Sign Informed Consent.
  • History of clinically defined, unilateral hemiparetic stroke, with radiologic exclusion of other possible diagnosis, causing weakness in 1 arm 6 months or more prior to enrollment.
  • Fugl-Meyer upper extremity score <= 50 at time of enrollment
  • Medically stable to participate in the study and have mobility, visual, and cognitive abilities sufficient to follow directions and engage in the gamified therapeutic tasks.

Exclusion Criteria:

  • Undergoing any significant medical treatments requiring regular visits, treatments, or therapies at the time of enrollment or anytime during the study.
  • Hair or scalp implant that would not allow near infrared spectroscopy probes to sit on scalp.
  • Injection of botulinum toxin to the paretic arm within 3 months of enrollment or during the study or injection of daxibotulinumtoxinA within 6 months of enrollment or during the study
  • Orthopedic, rheumatologic, or other medical disease that would make the procedures of participation dangerous, painful, or uncomfortable.
  • Contraindications to MRI, including intracranial magnetic items, implanted pumps, pacemakers, or stimulators, or claustrophobia.

Sites / Locations

  • University of MarylandRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient Robot-Assisted Training Group

Arm Description

Patients will undergo robot-assisted physical therapy three times a week, for a total of 9 sessions, while functional near-infrared spectroscopy data is collected.

Outcomes

Primary Outcome Measures

Changes in cortical connectivity measures as assessed using MRI
Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum. MRI sequences include T1 MPRAGE, BOLD (T2*), FLAIR T2, ASL, and DTI.
Changes in cortical connectivity measures as assessed using fNIRS
Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum.

Secondary Outcome Measures

Changes in arm kinematics (position)
Arm kinematics measures of position collected by the rehabilitation training technology devices
Changes in arm kinematics (velocity)
Arm kinematics measures of velocity collected by the rehabilitation training technology devices
Changes in arm kinematics (acceleration)
Arm kinematics measures of acceleration collected by the rehabilitation training technology devices
Changes in Fugl-Myer Scores for the Upper Extremity ("FM-UE")
Standardized bedside test examining the degree of motor impairment for the arm/hand. Scores range from 0 - 66 with higher scores representing better recovery.
Changes in Action Research Arm Test
Standardized bedside test examining behavioral tasks for the arm/hand. Scores range from 0-57 points, with a maximum score of 57 points indicating better performance.
Changes in Wolf Motor Function Test ("WMFT")
Standardized bedside test examining behavioral tasks for the arm/hand. Score Ranges Minimum 0 to Maximum 75; Lower scores are indicative of lower functioning levels.
Changes in Shoulder Abduction Finger Extension ("SAFE") score
Standardized bedside test examining strength of the arm/hand. Scores range from 0-10 with higher scores representing better strength.
Changes in NIH Stroke Scale Score ("NIHSS")
Standardized bedside test to assess stroke symptoms. Scores range from 0 - 42, where higher scores indicate greater symptom severity.
Changes in Stroke Impact Scale ("SIS")
Standardized questionnaire examining patient perceptions of how stroke impacts their function and quality of life. Scores range from 0 to 100 with higher scores indicating a higher quality of life.

Full Information

First Posted
July 25, 2022
Last Updated
February 1, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT05560867
Brief Title
Neural Mechanisms of Motor Recovery With Technology Assisted Training
Official Title
Neural Mechanisms of Motor Recovery With Technology Assisted Training for Post-stroke Hemiparesis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Stroke is a leading cause of disability that often impairs arm function and activities of daily living. The costs of rehabilitation are significant and practical constraints often limit therapy to the first few months after stroke. However many studies have shown that patients in the later stages post-stroke can still continue to benefit from rehabilitation. Technology-assisted therapy may offer a means to efficiently provide ongoing therapies to patients in the later stages (>6 months) post-stroke. This study will determine which patients are best able to benefit from this therapy approach, and will also expand our knowledge of which brain structures need to be intact for patients to benefit from technology-assisted training. The results of this study will help to improve rehabilitation and quality of life for disabled Americans.
Detailed Description
Study Description: This study will investigate the neural mechanisms of technology-assisted-training for post-stroke hemiparesis by using functional near-infrared-spectroscopy (fNIRS). Patients with hemiparesis affecting the arm will be brought in for 3 weeks of technology-assisted-training while having fNIRS recordings of their brain activity. Analysis of these brain activation patterns will help determine what areas of the brain are necessary to respond to this type of training. Objectives: 1) to investigate brain network activity changes that occur during technology-assisted-training and 2) to determine the baseline residual brain network connectivity required for patients to respond to robot-assisted-training. Endpoints: The study will evaluate increases in cortical connectivity between bilateral primary motor areas, angular gyrus and parietal operculum to test the hypothesis that cortical connectivity in these areas will positively correlate with improvement in technology-assisted-assessments. The study will also assess baseline connectivity of the angular gyrus and parietal operculum to sensorimotor networks to test the hypothesis that cortical connectivity in these areas will predict reductions in arm motor impairments that occur with technology-assisted-training. Study Population: Patients of either gender with chronic (at least 6 months or more) hemiparesis of the arm caused by a single unilateral stroke will be recruited from Baltimore city and the surrounding counties.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Stroke Sequelae
Keywords
stroke, robot-assisted rehabilitation, neural networks, fnirs, rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Robot-Assisted Training Group
Arm Type
Other
Arm Description
Patients will undergo robot-assisted physical therapy three times a week, for a total of 9 sessions, while functional near-infrared spectroscopy data is collected.
Intervention Type
Device
Intervention Name(s)
robot-assisted training
Other Intervention Name(s)
IMT InMotion Wrist Robot, IMT InMotion2 Shoulder-Elbow Robot, IMT InMotion2 Planar Robot
Intervention Description
These training platforms use gamified training tasks to improve motor control in the hemiparetic arm
Primary Outcome Measure Information:
Title
Changes in cortical connectivity measures as assessed using MRI
Description
Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum. MRI sequences include T1 MPRAGE, BOLD (T2*), FLAIR T2, ASL, and DTI.
Time Frame
Baseline MRI will be collected at the time of study enrollment (for a total of up to 4 weeks during study enrollment)
Title
Changes in cortical connectivity measures as assessed using fNIRS
Description
Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum.
Time Frame
Baseline fNIRS collected at the time of study enrollment, with repeated fNIRS measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Secondary Outcome Measure Information:
Title
Changes in arm kinematics (position)
Description
Arm kinematics measures of position collected by the rehabilitation training technology devices
Time Frame
Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Title
Changes in arm kinematics (velocity)
Description
Arm kinematics measures of velocity collected by the rehabilitation training technology devices
Time Frame
Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Title
Changes in arm kinematics (acceleration)
Description
Arm kinematics measures of acceleration collected by the rehabilitation training technology devices
Time Frame
Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Title
Changes in Fugl-Myer Scores for the Upper Extremity ("FM-UE")
Description
Standardized bedside test examining the degree of motor impairment for the arm/hand. Scores range from 0 - 66 with higher scores representing better recovery.
Time Frame
At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Title
Changes in Action Research Arm Test
Description
Standardized bedside test examining behavioral tasks for the arm/hand. Scores range from 0-57 points, with a maximum score of 57 points indicating better performance.
Time Frame
At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment).
Title
Changes in Wolf Motor Function Test ("WMFT")
Description
Standardized bedside test examining behavioral tasks for the arm/hand. Score Ranges Minimum 0 to Maximum 75; Lower scores are indicative of lower functioning levels.
Time Frame
At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment).
Title
Changes in Shoulder Abduction Finger Extension ("SAFE") score
Description
Standardized bedside test examining strength of the arm/hand. Scores range from 0-10 with higher scores representing better strength.
Time Frame
At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Title
Changes in NIH Stroke Scale Score ("NIHSS")
Description
Standardized bedside test to assess stroke symptoms. Scores range from 0 - 42, where higher scores indicate greater symptom severity.
Time Frame
At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Title
Changes in Stroke Impact Scale ("SIS")
Description
Standardized questionnaire examining patient perceptions of how stroke impacts their function and quality of life. Scores range from 0 to 100 with higher scores indicating a higher quality of life.
Time Frame
At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 88 years Able to provide informed consent based on Evaluation to Sign Informed Consent. History of clinically defined, unilateral hemiparetic stroke, with radiologic exclusion of other possible diagnosis, causing weakness in 1 arm 6 months or more prior to enrollment. Fugl-Meyer upper extremity score <= 50 at time of enrollment Medically stable to participate in the study and have mobility, visual, and cognitive abilities sufficient to follow directions and engage in the gamified therapeutic tasks. Exclusion Criteria: Undergoing any significant medical treatments requiring regular visits, treatments, or therapies at the time of enrollment or anytime during the study. Hair or scalp implant that would not allow near infrared spectroscopy probes to sit on scalp. Injection of botulinum toxin to the paretic arm within 3 months of enrollment or during the study or injection of daxibotulinumtoxinA within 6 months of enrollment or during the study Orthopedic, rheumatologic, or other medical disease that would make the procedures of participation dangerous, painful, or uncomfortable. Contraindications to MRI, including intracranial magnetic items, implanted pumps, pacemakers, or stimulators, or claustrophobia.
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Director, Brain Rehab and Recovery Lab
Phone
410-448-6763
Email
rbraun@som.umaryland.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Neural Mechanisms of Motor Recovery With Technology Assisted Training

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