Video Game-based Therapy for Arm Weakness In Progressive Multiple Sclerosis

Study Overview
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Brief Summary
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Participants will receive intensive therapy through a video game in their own homes for 1 month. The game is operated by movements of the body (no controller needed) and acts like a virtual therapist. Participants will agree to play the game for 30 hours. They will also receive 4 home visits from a therapist designed to increase use of their arm for daily activities that are important to them. Participants will also receive a smart watch that will measure use of their weaker arm and alert them when their arm is not participating in activities. Arm strength and function will be measured before and after the therapy program.

Detailed Description
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Randomized waitlist control trial. One group will receive treatment immediately (50%) and the other group will receive treatment following a three-week delay (50%). Group 1 will be assessed by physical/occupational therapists and rehabilitation psychologists (blinded to treatment phase) before and after the virtual gaming treatment. Group 2 will receive two baseline assessments (baseline followed by three weeks of usual and customary care and then another baseline before starting the gaming treatment), and again after three weeks of virtual gaming treatment.

Official Title
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Video Game-based Therapy for Arm Weakness In Progressive Multiple Sclerosis

Conditions
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Primary Progressive Multiple Sclerosis, Hemiparesis

Intervention / Treatment
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* Behavioral: Gaming CI Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have progressive multiple sclerosis resulting in upper extremity motor impairment. Have the ability to comprehend and participate in basic elements of the therapy. Have substantial non-use in the more affected upper extremity. Exclusion Criteria: Are currently participating in other experimental trials. Are currently participating in additional upper extremity therapy. Experienced relapse within the past 6 months. Too frail to undergo intensive rehabilitation, Those with serious, uncontrolled medical problems.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate Treatment<br>Patients will receive an in-home consultation with an occupational/physical therapist in which they are educated about the intervention, the system is set up, and they are guided through use of the system. After initial contact, therapist support will be available via telephone to address specific difficulties with operating the system, as well as three additional home visits throughout the 3 week intervention. The rehabilitation program requires use of the rehabilitation gaming system for 1.5 hours daily for 21 consecutive days (equivalent dosage to standard CI therapy), limb activation device worn for 90% of waking hours, and completion of the automated transfer package to facilitate real-world arm use (e.g., problem-solving modules, daily monitoring of arm use). After completing the intervention, the patient will receive additional consultation with the therapist to formulate goals for follow-up. Follow-up assessments will be conducted to assess long-term retention of motor gains. | Behavioral: Gaming CI Therapy<br>* Intensive remote (via video game) therapy for upper extremity hemiparesis.<br>|
| Active Comparator: Delayed Treatment<br>Patients will receive an in-home consultation with an occupational/physical therapist in which they are educated about the intervention, the system is set up, and they are guided through use of the system. After initial contact, therapist support will be available via telephone to address specific difficulties with operating the system, as well as three additional home visits throughout the 3 week intervention. The rehabilitation program requires use of the rehabilitation gaming system for 1.5 hours daily for 21 consecutive days (equivalent dosage to standard CI therapy), limb activation device worn for 90% of waking hours, and completion of the automated transfer package to facilitate real-world arm use (e.g., problem-solving modules, daily monitoring of arm use). After completing the intervention, the patient will receive additional consultation with the therapist to formulate goals for follow-up. Follow-up assessments will be conducted to assess long-term retention of motor gains. | Behavioral: Gaming CI Therapy<br>* Intensive remote (via video game) therapy for upper extremity hemiparesis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilateral Activity Monitors (Accelerometers) | Devices to monitor upper extremity movement throughout treatment | 0 to 1 Months | 
| Wolf Motor Function Test | Assessment to evaluate motor function | 0 to 1 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomechanical Measures | Recorded during game play through limb activation device and Kinect | 0 to 1 Months | 
| Multiple Sclerosis Impact Scale (MSIS-29) | Scale to asses living with MS | 0 to 1 Months | 
| Short form-36 Health Survey | Survey | 0 to 1 Months | 
| Neuro-QOL | Assessment to measure quality of life | 0 to 1 Months | 
| Patient Health Questionnaire (PHQ-9) |  | 0 to 1 Months | 
| Montreal Cognitive Assessment (MoCA) | Assessment to measure cognitive function | 0 to 1 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemiparesis, multiple sclerosis, progressive multiple sclerosis, primary progressive multiple sclerosis, secondary progressive multiple sclerosis, motor, physical therapy, physiotherapy, arm, hand, rehabilitation, MS, Constraint-induced movement therapy, video game, virtual reality, upper extremity, CI therapy, occupational therapy