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

NCT03094364 | Completed

• 1 other identifier: 60052127
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Progressive Multiple Sclerosis; Hemiparesis

Keywords

Constraint-induced movement therapy; video game; virtual reality; upper extremity; CI therapy; rehabilitation; hemiparesis; MS; multiple sclerosis; progressive multiple sclerosis; primary progressive multiple sclerosis; secondary progressive multiple sclerosis; motor; physical therapy; physiotherapy; occupational therapy; arm; hand

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Biomechanical Measures

  0 to 1 Months

• Multiple Sclerosis Impact Scale (MSIS-29)

  0 to 1 Months

• Short form-36 Health Survey

  0 to 1 Months

• Neuro-QOL

  0 to 1 Months

• Patient Health Questionnaire (PHQ-9)

  0 to 1 Months

Study Arms (2)

Immediate Treatment

ACTIVE COMPARATOR

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

Delayed Treatment

ACTIVE COMPARATOR

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

Interventions

Gaming CI Therapy BEHAVIORAL

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

Delayed Treatment; Immediate Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Lowell: lead
• Ohio State University: collaborator

Study Sites (1)

The Ohio State University, 2154 Dodd Hall

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Paresis; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy and Kinesiology

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 29, 2017
• Study Start: November 1, 2015
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)