Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis. The Neurolutions System is a brain-computer interface (BCI) comprised of a robotic orthosis, worn on the hand and wrist, and operated by the patient's brain waves which are measured by EEG electrodes. The system also utilizes a tablet interface to provide therapy instructions to the patient.

Detailed Description
-----------------
Participants will complete 12 weeks of home therapy with the Neurolutions IpsiHand System. Outcomes will be based on a comparison of the patient's baseline measurements to post-therapy assessments.

Official Title
-----------------
Ipsihand Device Use in Stroke Patients to Assess Motor Recovery of the Upper Extremity and Functional Outcomes

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

Intervention / Treatment
-----------------
* Device: IpsiHand Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6-months or more post stroke Presentation of upper extremity hemiparesis or hemiplegia Participants must english speaking Demonstrate intact cognition to provide informed consent Botox injections are allowed, and must continue regimen at regular intervals throughout the study Exclusion Criteria - Not active in another clinical study Not receiving formal therapy for the upper extremity No use of other modalities or technologies to the upper extremity Cognitive Impairment: Short Blessed Test Score 9 or above Significant Spasticity: Modified Ashworth Scale score 3 or more at the elbow Significant Hemispatial Neglect: Mesulam Cancellation Test 3 or more unilaterally Insufficient Strength: Motricity Index score for shoulder abduction 18 - Any contractors of the affected upper extremity that would not allow the IpsiHand robotic exoskeleton to be worn comfortably and/or safely for device use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IpsiHand Device<br>All participants will receive treatment with the IpsiHand Device. | Device: IpsiHand Therapy<br>* The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of hometherapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment - Upper Extremity | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity. | Fugl-Meyer Assessment - Upper Extremity average change in points from the baseline average score and 12-week average score. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks | The Arm Motor Ability Test (AMAT is used to measure functional limitation in the upper extremity in rehabilitative trials enrolling individuals with stroke primarily. The measure requires clients to perform 28 common unilateral and bilateral UE tasks. Performance on each task is timed by the evaluator and rated by the evaluator using a 6-point Functional Ability Scale from 0 to 5. A score of 0 indicates no attempt moving the affected upper extremity in the task. A score of 5 indicates one is using their affected arm with full movement, normal. One can achieve a total a range of 0 points to 140 points | Change in AMAT score (points) from Baseline to 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Brain-Computer Interface