SPiRE Maestro Hand Exoskeleton for Rehabilitation Post Stroke

Study Overview
=================
Brief Summary
-----------------
The research team will develop a novel training tool to improve finger joint coordination, to address the unmet need in the current rehabilitation, thereby enhancing hand function and contributing to improved independence and quality of life for Veterans with stroke.

Detailed Description
-----------------
The research team will determine feasibility of training using CA and TA controllers in subacute stroke. Specifically, we will examine if joint coordination improves over a training session. The investigators will compare the extent of improvement for each controller and impairment severity.

Official Title
-----------------
Feasibility of Using Maestro Hand Exoskeleton in Post-stroke Hand Rehabilitation to Improve Joint Coordination

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Exoskeleton


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Veterans with a stroke 1-6 months ago Ability to move fingers (Chedoke-McMaster Hand Section Stage 2-4) Exclusion Criteria: Inability to follow 2-step commands Severe muscle tone prohibiting proper placement of the fingers (Modified Ashworth Scale, MAS=5 out of 5) Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will experience all controller conditions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>All participants will receive assistance to move finger joints away from the compensatory coordination (compensation avoidance), toward the desired trajectories (task assistance), both, and none in different days. | Device: Exoskeleton<br>* Participants will receive assistance to move finger joints away from the compensatory coordination (compensation avoidance), toward the desired trajectories (task assistance), both, and none in different days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in finger joint torque assistance | Change in finger joint torque assistance needed from the 1st half to the 2nd half of the 1-hour training session. Reduction in torque is considered a good outcome. There is no predefined minimum/maximum. | from the 1st half to the 2nd half of the 1-hour training session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurologic Rehabilitation, Soft Robotics, Robotic Exoskeleton, Physical Medicine and Rehabilitation, Rehabilitation Exercise