Pilot Study to Assess the Feasibility and Initial Efficacy of Therapist-as-consultant, Game-based CI Therapy

Study Overview
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Brief Summary
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Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant, game-based CI therapy. Pre/post study design. Participant received a target of 30 hours game-based motor intervention, 100 hours constraint of the less affected upper extremity, and 5 hours therapist consultation (including completion of a behavioral contract at the first study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and post-treatment testing performed within 1 week prior to and 1 week post-intervention by an independent tester.

Official Title
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A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis

Conditions
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Stroke, Hemiparesis, Upper Extremity Dysfunction

Intervention / Treatment
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* Behavioral: Hemiparesis Therapy with VR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study Male or female aged > 17 Preserved ability to comprehend English and participate in basic elements of the therapy Community-dwelling Experienced mild to moderate hemiparesis at least six months prior Can independently operate the gaming system (those with severe cognitive impairments can usually achieve this) Corrected vision of at least 20/70 as assessed by their ability to identify game objects on the monitor from 5 feet away Exclusion Criteria: concurrent participation in other experimental upper extremity trials concurrent participation in other outpatient rehabilitation for their upper extremity Botox within the last 3 months (confound) near-normal motor function (9-hole Peg Test score above the 10th percentile of a normative sample) minimal nonuse (Motor Activity Log at baseline >2.5, Accelerometry > 60%) major medical issues that would interfere with study treatments or make intensive rehabilitation difficult to tolerate

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke<br> | Behavioral: Hemiparesis Therapy with VR<br>* An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids<br>|
| Experimental: Hemiparesis other<br> | Behavioral: Hemiparesis Therapy with VR<br>* An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Motor Activity Log | Self-report measure of arm use for daily activities | Week 0 and Week 3 | 
| Change in Wolf Motor Function Test | Objective measure of motor function in a laboratory setting | Week 0 and Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematic Data | Kinematic data recorded during game play | Week 0 and Week 3 | 
| Brief Kinesthesia test | Clinical Assessment of sensation | Week 0 and Week 3 | 
| Patient Health Questionnaire | Measures Depression | Week 0 and Week 3 | 
| Strok Specific Quality of Life Scale | Quality of life measurement | Week 0 and Week 3 | 
| Weschler Adult Intelligence Scale Symbol Seach | Cognitive processing speed assessment | Week 0 and Week 3 | 
| Montreal Cognitive Assessment | Baseline cognitive screen | Week 0 and Week 3 | 
| Survey | Survey on satisfaction with the intervention | Week 0 and Week 3 | 
| Mitt Compliance | Hours of use | Week 0 and Week 3 | 
| Total game-play time |  | Week 0 and Week 3 | 
| Gestures | Number of gestures of each type registered in game | Week 0 and Week 3 | 
| Bilateral activity monitors | Objective measure of arm use | Week 0 and Week 3 | 
| Action Research Arm Test (ARAT) | Asses Changes in Limb Function | Week 0 and Week 3 |