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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03094364
Other study ID # 60052127
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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