search
Back to results

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

Primary Purpose

Primary Progressive Multiple Sclerosis, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gaming CI Therapy
Sponsored by
University of Massachusetts, Lowell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Progressive Multiple Sclerosis focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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.

Sites / Locations

  • The Ohio State University, 2154 Dodd Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Immediate Treatment

Delayed Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Biomechanical Measures
Recorded during game play through limb activation device and Kinect
Multiple Sclerosis Impact Scale (MSIS-29)
Scale to asses living with MS
Short form-36 Health Survey
Survey
Neuro-QOL
Assessment to measure quality of life
Patient Health Questionnaire (PHQ-9)
Montreal Cognitive Assessment (MoCA)
Assessment to measure cognitive function

Full Information

First Posted
March 23, 2017
Last Updated
April 16, 2019
Sponsor
University of Massachusetts, Lowell
Collaborators
Ohio State University
search

1. Study Identification

Unique Protocol Identification Number
NCT03094364
Brief Title
Video Game-based Therapy for Arm Weakness In Progressive Multiple Sclerosis
Official Title
Video Game-based Therapy for Arm Weakness In Progressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Lowell
Collaborators
Ohio State University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Delayed Treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gaming CI Therapy
Intervention Description
Intensive remote (via video game) therapy for upper extremity hemiparesis.
Primary Outcome Measure Information:
Title
Bilateral Activity Monitors (Accelerometers)
Description
Devices to monitor upper extremity movement throughout treatment
Time Frame
0 to 1 Months
Title
Wolf Motor Function Test
Description
Assessment to evaluate motor function
Time Frame
0 to 1 Months
Secondary Outcome Measure Information:
Title
Biomechanical Measures
Description
Recorded during game play through limb activation device and Kinect
Time Frame
0 to 1 Months
Title
Multiple Sclerosis Impact Scale (MSIS-29)
Description
Scale to asses living with MS
Time Frame
0 to 1 Months
Title
Short form-36 Health Survey
Description
Survey
Time Frame
0 to 1 Months
Title
Neuro-QOL
Description
Assessment to measure quality of life
Time Frame
0 to 1 Months
Title
Patient Health Questionnaire (PHQ-9)
Time Frame
0 to 1 Months
Title
Montreal Cognitive Assessment (MoCA)
Description
Assessment to measure cognitive function
Time Frame
0 to 1 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Ohio State University, 2154 Dodd Hall
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made public 1 year after study completion.

Learn more about this trial

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

We'll reach out to this number within 24 hrs