Chronic Stroke
Conditions
Keywords
Upper Extremity Hemiparesis, Virtual Reality (VR)
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVirtual Reality Mystic Isle Game
8 week virtual reality based exercise program
BEHAVIORALStandard Home Exercise Program
8 week standard occupational therapy home exercise program
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Stroke Subjects 1. Have a cerebrovascular accident diagnosis at least 6 months prior to study enrollment 2. Age 45-85 3. Can comprehend English 4. Have an internet connection in the home 5. Mini Mental Status Examination score \> 24 (no more than mild cognitive deficits) 6. Mild to moderate motor deficits (range of motion screening- \> 45 degrees shoulder flexion, some wrist movement, partial extension of the fingers) 7. Functional balance (Berg Balance Scale score \> 45) * Caregivers: 1. Provide care or support to a subject that is participating in this research study. This person does not need to be related to the stroke subject. 2. Over the age of 18 3. Can comprehend English
Exclusion criteria
* Stroke Subject: 1. A medical condition that prevents interaction with a television or video games 2. Receiving occupational or physical therapy services at the time of study involvement * Caregiver: NONE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Canadian Occupational Performance Measure | Baseline, 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Modified Ashworth Scale | Baseline, 8 weeks | Assess muscle tone of various joints. Only joints with any spasticity will be recorded. Scale ranges from 0 (no spasticity) to 3 (rigid joint). |
| Change from baseline in the range of motion of shoulder | Baseline, 8 weeks | Angle (degrees) of the shoulder joint as measured by a goniometer |
| Change from baseline in the bicep strength | Baseline, 8 weeks | Muscle strength of the biceps muscle as measured by manual muscle testing (scale 0-5) |
| Change from baseline in the PROMIS-29 | Baseline, 8 weeks | 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). |
| Mini-Mental Status Examination | Screening | Questionnaire used to measure cognitive impairment |
| Change from baseline in the Performance Assessment of Self-Care Skills | Baseline, 8 weeks | 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. |
| Intrinsic Motivation Inventory | 8 weeks | 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 |
| Range of Motion Screening | Screening | Participant will be screened to see if they have the minimal movement at the shoulder and elbow. |
| Berg Balance Scale | Screening | Assessment of balance ability. Score range is 0-56. Cut-off for screening is 45 |
| Change from baseline in the Fugl-Meyer Assessment - Upper Extremity | Baseline, 8 weeks | Assessment of upper extremity function post-stroke. Scale ranges from 0-66. |
| Demographic and Health History Questionnaire | Baseline assessment | Includes questions related to demographics and health history |
Countries
United States
Outcome results
None listed