Game-Based Home Exercise Programs in Chronic Stroke: A Feasibility Study

Not Applicable

Completed

• Conditions: Chronic Stroke
• Interventions: Behavioral: Virtual Reality Mystic Isle Game; Behavioral: Standard Home Exercise Program

• Registration Number: NCT03531567
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study Start: 2017-09-21
• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Mystic Isle Game	Virtual Reality Mystic Isle Game	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.
Standard Home Exercise Program	Standard Home Exercise Program	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline in the range of motion of shoulder	Baseline, 8 weeks	Angle (degrees) of the shoulder joint as measured by a goniometer
Mini-Mental Status Examination	Screening	Questionnaire used to measure cognitive impairment
Demographic and Health History Questionnaire	Baseline assessment	Includes questions related to demographics and health history
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.
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.
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 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 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).
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.
Berg Balance Scale	Screening	Assessment of balance ability. Score range is 0-56. Cut-off for screening is 45

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States