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

October 9, 2018 updated by: Rachel Proffitt, University of Missouri-Columbia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: Virtual Reality Mystic Isle Game
8 week virtual reality based exercise program
ACTIVE_COMPARATOR: 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.
Behavioral: Standard Home Exercise Program
8 week standard occupational therapy home exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Canadian Occupational Performance Measure
Time Frame: 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.
Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Performance Assessment of Self-Care Skills
Time Frame: 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.
Baseline, 8 weeks
Change from baseline in the Modified Ashworth Scale
Time Frame: 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).
Baseline, 8 weeks
Change from baseline in the range of motion of shoulder
Time Frame: Baseline, 8 weeks
Angle (degrees) of the shoulder joint as measured by a goniometer
Baseline, 8 weeks
Change from baseline in the bicep strength
Time Frame: Baseline, 8 weeks
Muscle strength of the biceps muscle as measured by manual muscle testing (scale 0-5)
Baseline, 8 weeks
Change from baseline in the PROMIS-29
Time Frame: 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).
Baseline, 8 weeks
Mini-Mental Status Examination
Time Frame: Screening
Questionnaire used to measure cognitive impairment
Screening
Demographic and Health History Questionnaire
Time Frame: Baseline assessment
Includes questions related to demographics and health history
Baseline assessment
Intrinsic Motivation Inventory
Time Frame: 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
8 weeks
Range of Motion Screening
Time Frame: Screening
Participant will be screened to see if they have the minimal movement at the shoulder and elbow.
Screening
Berg Balance Scale
Time Frame: Screening
Assessment of balance ability. Score range is 0-56. Cut-off for screening is 45
Screening
Change from baseline in the Fugl-Meyer Assessment - Upper Extremity
Time Frame: Baseline, 8 weeks
Assessment of upper extremity function post-stroke. Scale ranges from 0-66.
Baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 21, 2017

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

September 30, 2018

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (ACTUAL)

May 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008940

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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