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

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.

Study Overview

• Status: Completed
• Conditions: Hemiparesis; Primary Progressive Multiple Sclerosis
• Intervention / Treatment: Behavioral: Gaming CI Therapy

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University, 2154 Dodd Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Lowell
• Collaborators: Ohio State University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): October 31, 2018
• Study Completion (ACTUAL): October 31, 2018

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (ACTUAL): March 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: rehabilitation; MS; multiple sclerosis; physiotherapy; hemiparesis; virtual reality; physical therapy; occupational therapy; hand; video game; motor; upper extremity; arm; Constraint-induced movement therapy; progressive multiple sclerosis; secondary progressive multiple sclerosis; primary progressive multiple sclerosis; CI therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Paresis
• Other Study ID Numbers: 60052127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made public 1 year after study completion.