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Effects of Intensive Training on Reocvery of Fingers Dexterity Following Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Intensive Finger Individuation Therapy
Intensive non-directed finger movement therapy
Sponsored by
Loewenstein Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First symptomatic ischemic or hemorrhagic stroke
  • Clinically evident upper-limb motor deficit
  • Understand the study aim, is able to cooperate with the task for the specified time
  • Clinically stable

Exclusion Criteria:

  • Other neurological or psychiatric illness which affects upper-limb motor function
  • An orthopedic or rheumatologic disease that affects the ability to undergo a robotic hand therapy.
  • Sensory problems that prevent the patient from reporting pain during the robotic hand therapy
  • Skin breakdown or wounds located in places where the hand contacts the robot.
  • Patients with C/I to TMS (history of seizures, the existence of cardiac pacer, VP shunt, spinal stimulator or any other hardware that may malfunction at the presence of strong magnetic fields) will no undergo TMS but may participate in the study
  • Participation in another interventional study for upper limb rehabilitation

Sites / Locations

  • Loewenstein Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Control

Arm Description

The patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded visually and auditory when a higher degree of finger individuation will be measured. Specifically, when the applied force of the instructed fingers hit the predefined force target and at the same, the force in the non-instructed fingers stay as low as possible

The patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded in a way that is unrelated to the degree of individuation. In other words, a successful trial considered when the applied force of the instructed fingers hits the predefined force target regardless of the force exerted in the non-instructed fingers.

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer Assessment Score for Upper Extremity at the immediate post-intervention time
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Change in Fugl-Meyer Assessment Score for Upper Extermity at 1-month post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Change in Fugl-Meyer Assessment Score for Upper Extermity at 3-month post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Change in Individuation Index at the immediate post-intervention time
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Change in Individuation Index at 1-month post-intervention
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Change in Individuation Index at 3-month post-intervention
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.

Secondary Outcome Measures

Arm Research Action Test (ARAT) Score at the immediate post-intervention time
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Tange: 0 - 57. Higher values correlate with better motor control.
Arm Research Action Test (ARAT) Score at at 1-month post-intervention
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Range: 0 - 57. Higher values correlate with better motor control.
Arm Research Action Test (ARAT) Score at at 3-month post-intervention
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Range: 0 - 57. Higher values correlate with better motor control.
Change in M1 MEP (motor evoked potentials) amplitude at immediate post-intervention time
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Change in M1 MEP (motor evoked potentials) amplitude at 1-month post-intervention
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Change in MEP (motor evoked potentials) amplitude at 3-months post-intervention
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Change in extent of SICI (short-interval cortical inhibition) at the immediate post-intervention time
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Change in extent of SICI (short-interval cortical inhibition) at 1-month post-intervention
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Change in extent of SICI (short-interval cortical inhibition) at 3-months post-intervention
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.

Full Information

First Posted
December 31, 2019
Last Updated
September 17, 2022
Sponsor
Loewenstein Hospital
Collaborators
Technion, Israel Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04229329
Brief Title
Effects of Intensive Training on Reocvery of Fingers Dexterity Following Stroke
Official Title
The Effect of Intensive Training on Recovery of Fingers Dexterity Following Stroke: Behavioral, Physiological and Anatomical Predictors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loewenstein Hospital
Collaborators
Technion, Israel Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The investigators aim to test whether intensive training of finger individuation during the sensitive window of the subacute phases can lead to a clinically-meaningful recovery of dexterous movement in stroke patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded visually and auditory when a higher degree of finger individuation will be measured. Specifically, when the applied force of the instructed fingers hit the predefined force target and at the same, the force in the non-instructed fingers stay as low as possible
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
The patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded in a way that is unrelated to the degree of individuation. In other words, a successful trial considered when the applied force of the instructed fingers hits the predefined force target regardless of the force exerted in the non-instructed fingers.
Intervention Type
Combination Product
Intervention Name(s)
Intensive Finger Individuation Therapy
Intervention Description
Interactive robot-mediated treatment aimed at increased individuation done repeatedly for at least1 hour per day for 2 weeks (5 training days a week).
Intervention Type
Combination Product
Intervention Name(s)
Intensive non-directed finger movement therapy
Intervention Description
Interactive robot-mediated treatment not aimed specifically at increased individuation done repeatedly for at least 1 hour per day for 2 weeks (5 training days per week)
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment Score for Upper Extremity at the immediate post-intervention time
Description
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Time Frame
Change from Baseline Score at 1-3 days post-intervention
Title
Change in Fugl-Meyer Assessment Score for Upper Extermity at 1-month post-intervention
Description
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Time Frame
Change from Baseline Score at 1 month post-intervention
Title
Change in Fugl-Meyer Assessment Score for Upper Extermity at 3-month post-intervention
Description
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Time Frame
Change from Baseline Score at 3 month post-intervention
Title
Change in Individuation Index at the immediate post-intervention time
Description
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Time Frame
Change from Baseline Score at 1-3 days post-intervention
Title
Change in Individuation Index at 1-month post-intervention
Description
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Time Frame
Change from Baseline Score at 1-month post-intervention
Title
Change in Individuation Index at 3-month post-intervention
Description
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Time Frame
Change from Baseline Score at 3-month post-intervention
Secondary Outcome Measure Information:
Title
Arm Research Action Test (ARAT) Score at the immediate post-intervention time
Description
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Tange: 0 - 57. Higher values correlate with better motor control.
Time Frame
Change from Baseline Score at 1-3 days post-intervention
Title
Arm Research Action Test (ARAT) Score at at 1-month post-intervention
Description
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Range: 0 - 57. Higher values correlate with better motor control.
Time Frame
Change from Baseline Score at 1-month post-intervention
Title
Arm Research Action Test (ARAT) Score at at 3-month post-intervention
Description
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Range: 0 - 57. Higher values correlate with better motor control.
Time Frame
Change from Baseline Score at 3-month post-intervention
Title
Change in M1 MEP (motor evoked potentials) amplitude at immediate post-intervention time
Description
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Time Frame
Change from Baseline Score at 1-3 days post-intervention
Title
Change in M1 MEP (motor evoked potentials) amplitude at 1-month post-intervention
Description
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Time Frame
Change from Baseline Score at 1-month post-intervention
Title
Change in MEP (motor evoked potentials) amplitude at 3-months post-intervention
Description
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Time Frame
Change from Baseline Score at 3-months post-intervention
Title
Change in extent of SICI (short-interval cortical inhibition) at the immediate post-intervention time
Description
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Time Frame
Change from Baseline Score at 1-3 days post-intervention
Title
Change in extent of SICI (short-interval cortical inhibition) at 1-month post-intervention
Description
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Time Frame
Change from Baseline Score at 1-month post-intervention
Title
Change in extent of SICI (short-interval cortical inhibition) at 3-months post-intervention
Description
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Time Frame
Change from Baseline Score at 3-months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First symptomatic ischemic or hemorrhagic stroke Clinically evident upper-limb motor deficit Understand the study aim, is able to cooperate with the task for the specified time Clinically stable Exclusion Criteria: Other neurological or psychiatric illness which affects upper-limb motor function An orthopedic or rheumatologic disease that affects the ability to undergo a robotic hand therapy. Sensory problems that prevent the patient from reporting pain during the robotic hand therapy Skin breakdown or wounds located in places where the hand contacts the robot. Patients with C/I to TMS (history of seizures, the existence of cardiac pacer, VP shunt, spinal stimulator or any other hardware that may malfunction at the presence of strong magnetic fields) will no undergo TMS but may participate in the study Participation in another interventional study for upper limb rehabilitation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shay Ofir-Geva, M.D.
Phone
972-522204842
Email
shinofir@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Silvi Frenkel-Toledo, Ph.D.
Phone
972-545509413
Email
silvft@ariel.ac.il
Facility Information:
Facility Name
Loewenstein Rehabilitation Center
City
Raanana
ZIP/Postal Code
43100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shay ofir
Phone
972-522204842
Email
shinofir@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Effects of Intensive Training on Reocvery of Fingers Dexterity Following Stroke

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