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

Sponsor

University of Massachusetts, Lowell (Other)

Overall Status

Completed

CT.gov ID

NCT03094364

Collaborator

Ohio State University (Other)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Progressive Multiple Sclerosis Hemiparesis	Behavioral: Gaming CI Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Oct 31, 2018

Actual Study Completion Date :

Oct 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Immediate Treatment 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 Intensive remote (via video game) therapy for upper extremity hemiparesis.
Active Comparator: Delayed Treatment 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 Intensive remote (via video game) therapy for upper extremity hemiparesis.

Arm

Intervention/Treatment

Active Comparator: Immediate Treatment

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

Intensive remote (via video game) therapy for upper extremity hemiparesis.

Active Comparator: Delayed Treatment

Behavioral: Gaming CI Therapy

Intensive remote (via video game) therapy for upper extremity hemiparesis.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Biomechanical Measures [0 to 1 Months]
Recorded during game play through limb activation device and Kinect
Multiple Sclerosis Impact Scale (MSIS-29) [0 to 1 Months]
Scale to asses living with MS
Short form-36 Health Survey [0 to 1 Months]
Survey
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.