Clinical trial NCT03094364: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Massachusetts, Lowell
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2017-03-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Bilateral Activity Monitors (Accelerometers)
timeFrame: 0 to 1 Months
measure: Wolf Motor Function Test
timeFrame: 0 to 1 Months
Secondary outcomes:
measure: Biomechanical Measures
timeFrame: 0 to 1 Months
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: 0 to 1 Months
measure: Short form-36 Health Survey
timeFrame: 0 to 1 Months
measure: Neuro-QOL
timeFrame: 0 to 1 Months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 0 to 1 Months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 0 to 1 Months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University, 2154 Dodd Hall
state: Ohio
Study officials:
References: