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

NCT ID: NCT03094364

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-10-31

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.

Conditions

Primary Progressive Multiple Sclerosis; Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Gaming CI Therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Gaming CI Therapy

Intervention Type: BEHAVIORAL

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

Interventions

Gaming CI Therapy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: collaborator

University of Massachusetts, Lowell

OTHER

Sponsor Role: lead

Responsible Party

Lynne Gauthier

Associate Professor of Physical Therapy and Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University, 2154 Dodd Hall

Columbus, Ohio, United States

Countries

United States

Other Identifiers

60052127

Identifier Type: -

Identifier Source: org_study_id