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OpenTrials
Completed

NCT Number: NCT03094364

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.

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Key information

Conditions

Primary Progressive Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Hemiparesis Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Neurologic Manifestations Paresis Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University, 2154 Dodd Hall

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gaming CI Therapy

Behavioral

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

Primary outcomes

  1. Bilateral Activity Monitors (Accelerometers)

    Time frame: 0 to 1 Months

    Devices to monitor upper extremity movement throughout treatment

  2. Wolf Motor Function Test

    Time frame: 0 to 1 Months

    Assessment to evaluate motor function

Secondary outcomes

  1. Biomechanical Measures

    Time frame: 0 to 1 Months

    Recorded during game play through limb activation device and Kinect

  2. Multiple Sclerosis Impact Scale (MSIS-29)

    Time frame: 0 to 1 Months

    Scale to asses living with MS

  3. Short form-36 Health Survey

    Time frame: 0 to 1 Months

    Survey

  4. Neuro-QOL

    Time frame: 0 to 1 Months

    Assessment to measure quality of life

  5. Patient Health Questionnaire (PHQ-9)

    Time frame: 0 to 1 Months

  6. Montreal Cognitive Assessment (MoCA)

    Time frame: 0 to 1 Months

    Assessment to measure cognitive function

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Lowell

Other

Collaborators

  • Ohio State University

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2017
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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