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

Hemiparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094364
• Other study ID #: 60052127
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: October 31, 2018

Study information

• Verified date: April 2019
• Source: University of Massachusetts, Lowell
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemiparesis
• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Paresis
• Primary Progressive Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Gaming CI Therapy
Intensive remote (via video game) therapy for upper extremity hemiparesis.

Locations

Country	Name	City	State
United States	The Ohio State University, 2154 Dodd Hall	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Lowell	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bilateral Activity Monitors (Accelerometers)	Devices to monitor upper extremity movement throughout treatment	0 to 1 Months
Primary	Wolf Motor Function Test	Assessment to evaluate motor function	0 to 1 Months
Secondary	Biomechanical Measures	Recorded during game play through limb activation device and Kinect	0 to 1 Months
Secondary	Multiple Sclerosis Impact Scale (MSIS-29)	Scale to asses living with MS	0 to 1 Months
Secondary	Short form-36 Health Survey	Survey	0 to 1 Months
Secondary	Neuro-QOL	Assessment to measure quality of life	0 to 1 Months
Secondary	Patient Health Questionnaire (PHQ-9)		0 to 1 Months
Secondary	Montreal Cognitive Assessment (MoCA)	Assessment to measure cognitive function	0 to 1 Months