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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-21

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual Reality Mystic Isle Game

Intervention Type BEHAVIORAL

8 week virtual reality based 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.

Group Type ACTIVE_COMPARATOR

Standard Home Exercise Program

Intervention Type BEHAVIORAL

8 week standard occupational therapy home exercise program

Interventions

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Virtual Reality Mystic Isle Game

8 week virtual reality based exercise program

Intervention Type BEHAVIORAL

Standard Home Exercise Program

8 week standard occupational therapy home exercise program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No