An interventional study of Virtual Reality Mystic Isle Game and Standard Home Exercise Program in Chronic Stroke, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-10-10.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
Study will look at the effect of a game-based, task-oriented home exercise program on adherence in persons with chronic (> 6 months post) stroke as compared to a standard home exercise program. The study will also look at the effect of a game-based, task-oriented home exercise program on upper extremity motor function and occupational performance in persons with chronic (> 6 months post) stroke as compared to a standard home exercise program. Finally, the study will look at barriers and facilitators to successful use of the game-based, task-oriented home exercise program in the home setting.
Approximately 26% of stroke survivors are still fully dependent in activities of daily living (ADLs) when they enter the chronic phase at 6-months post stroke, and over half have hemiparesis that impacts upper extremity motor function. Exercise and activity in the chronic phase of stroke are essential in reducing disability, improving balance, increasing mobility, and improving overall quality of life. Without regular activity and exercise in the chronic phase, survivors are at risk for a developing comorbid conditions (e.g., diabetes) and experiencing a recurrent stroke. Unfortunately, people with stroke report many barriers to exercise, such as fatigue or pain, and lack of motivation and engagement. A promising solution may lie in interactive video games and virtual reality (VR), which have been used as intervention tools to potentially increase patient engagement and adherence, over the past 15 years. The investigators have developed an interactive, customized VR system called Mystic Isle that has shown to be feasible for general home-based rehabilitation. Mystic Isle utilizes portable, low-cost technology (the Microsoft Kinect® sensor, Microsoft) and can provide a customized program with remote monitoring by an occupational therapist (OT). This study will explore the preliminary effect of the game-based home program on adherence to a home program in comparison to a control. It will also explore the barriers and facilitators to home use of a virtual reality-based intervention.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 8 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
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Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.
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Stroke Subjects
Caregivers:
Exclusion Criteria:
Stroke Subject:
Subjects in the treatment arm will complete a prescribed 2-month treatment using the virtual reality program Mystic Isle. The OT will follow the "Treatment Arm Intervention Protocol", which provides standardized guidelines for grading the intensity, level of challenge, and types of games/activities of the intervention up or down. The OT will complete weekly phone calls with participant to discuss progress, answer any questions, and remotely make updates to the game as necessary. The total time on active treatment for a subject is 8 weeks. The maximum amount of time spent on the intervention will be 7 hours/week. The minimum amount of time spent on the intervention will be 3.5 hours/week.
Behavioral: Virtual Reality Mystic Isle Game
Subjects assigned to the control arm will complete the prescribed 2-month treatment. The OT will follow the "Control Arm Intervention Protocol" to design and prescribe the home exercise program. The OT will complete weekly phone calls with the participant to check on progress, adherence, and update the exercises as necessary. The total time on active treatment for a subject is 8 weeks. The maximum amount of time spent on the control intervention will be 7 hours/week. The minimum amount of time spent on the control intervention will be 3.5 hours/week.
Behavioral: Standard Home Exercise Program
8 week virtual reality based exercise program
8 week standard occupational therapy home exercise program
Change from baseline in the Canadian Occupational Performance Measure
The Canadian occupational Performance Measure is a measure of the subject's self-rated performance and satisfaction of their performance with 5 self-identified areas of occupation/activities.
Time frame: Baseline, 8 weeks
Change from baseline in the Performance Assessment of Self-Care Skills
The Performance Assessment of Self-Care Skills (PASS) assesses basic self-care and instrumental activities of daily living. Subscales: Independence, Safety, Adequacy (minimum: 0, maximum: 3). There is no total score reported.
Time frame: Baseline, 8 weeks
Change from baseline in the Modified Ashworth Scale
Assess muscle tone of various joints. Only joints with any spasticity will be recorded. Scale ranges from 0 (no spasticity) to 3 (rigid joint).
Time frame: Baseline, 8 weeks
Change from baseline in the range of motion of shoulder
Angle (degrees) of the shoulder joint as measured by a goniometer
Time frame: Baseline, 8 weeks
Change from baseline in the bicep strength
Muscle strength of the biceps muscle as measured by manual muscle testing (scale 0-5)
Time frame: Baseline, 8 weeks
Change from baseline in the PROMIS-29
General assessment of quality of life and participation in daily life. Assessment is from the standardized NIH Toolbox. T-scores are reported on scale of 0-100 (50 is average).
Time frame: Baseline, 8 weeks
Mini-Mental Status Examination
Questionnaire used to measure cognitive impairment
Time frame: Screening
Demographic and Health History Questionnaire
Includes questions related to demographics and health history
Time frame: Baseline assessment
Intrinsic Motivation Inventory
Determines the person's motivation for completing the task. Non-standardized scale. Scores are calculated for the following sub-scales: Interest/enjoyment, perceived competence, perceived choice, pressure/tension. There are no normative values
Time frame: 8 weeks
Range of Motion Screening
Participant will be screened to see if they have the minimal movement at the shoulder and elbow.
Time frame: Screening
Berg Balance Scale
Assessment of balance ability. Score range is 0-56. Cut-off for screening is 45
Time frame: Screening
Change from baseline in the Fugl-Meyer Assessment - Upper Extremity
Assessment of upper extremity function post-stroke. Scale ranges from 0-66.
Time frame: Baseline, 8 weeks
Plan to share: No — All de-identified clinical outcome assessment data with accompanying key will be deposited in MOspace Institutional Repository, the University of Missouri's digital institutional repository. MOspace is based on MIT's DSpace technology and is a joint venture of the University of Missouri's Division of Information Technology and the University Libraries. MOspace items will include appropriate metadata and a permanent URL. Items will be freely available via the MOspace web site at https://mospace.umsystem.edu and will be searchable via Google and other search engines.
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University of Missouri-Columbia