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

Not Applicable

Completed

• Conditions: Primary Progressive Multiple Sclerosis; Hemiparesis

• Registration Number: NCT03094364
• Lead Sponsor: University of Massachusetts, Lowell

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wolf Motor Function Test	0 to 1 Months	Assessment to evaluate motor function
Bilateral Activity Monitors (Accelerometers)	0 to 1 Months	Devices to monitor upper extremity movement throughout treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Ohio State University, 2154 Dodd Hall; 🇺🇸 Columbus, Ohio, United States