RehabTouch Home Therapy for Stroke Patients

Study Overview
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Brief Summary
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We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.

Official Title
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RehabTouch: A Mixed-reality Gym for Rehabilitating the Hands, Arms, Trunk, and Legs After Stroke

Conditions
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Cerebral Stroke

Intervention / Treatment
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* Device: RehabTouch
* Other: Conventional tabletop exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to 85 years old Upper extremity weakness measured by a clinical scale Absence of moderate to severe pain on affected upper extremity Able to understand the instructions to operate RehabTouch Exclusion Criteria: Concurrent severe medical problems, visual deficits, severe neglect or apraxia Enrollment to other therapy studies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RehabTouch Exercise Program<br>Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. | Device: RehabTouch<br>* Exercise using the motion sensing devices and a computer<br>* Other names: FitMi;|
| Active Comparator: Conventional tabletop exercise program<br>Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. | Other: Conventional tabletop exercise program<br>* Exercise following printed sheets of exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy | The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly. | From Baseline to One-month Post-therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Box and Blocks Test Score | The Box & Blocks Test (BBT) score assess hand function and gripping ability by instructing an individual to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. | From Baseline to One-month Post-therapy | 
| 10 Meter Walk Test | The 10MWT assesses walking speed in meters per second over a short duration. | From Baseline to One-month Post-therapy | 
| Motor Activity Log | The Motor Activity Log (MAL) is a semi-structured interview to assess arm function after hemiparetic stroke. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 28 daily functional tasks on a 0-5 point scale. For the QOM subscale, 0 represents an inability to use the affected arm to perform an activity, while 5 represents a normal ability to use the affected arm. For the AOM scale, 0 represents never using the affected arm to perform the activity, and 5 indicates always using the affected arm to perform the activity. | One-month Post-therapy | 
| Visual Analog Pain Scale | A standard analog scale that ranges from 0 to 10 for assessing pain. | From Baseline to One-month Post-therapy | 
| Modified Ashworth Spasticity Scale | The Modified Ashworth Spasticity (MAS) Scale measures spasticity in patients with lesions of the Central Nervous System. Tests resistance to passive movement about a joint with varying degrees of velocity, with movements in flexion and extension scored separately. Scores for each movement direction and joint range from 0-5, with 6 choices. A score of 0 indicates no increase in tone during movement. A score of 5 indicates that the limb was rigid during the passive movement. | From Baseline to One-month Post-therapy |