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Completed

NCT Number: NCT03531567

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

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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Key information

Conditions

Chronic Stroke

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stroke Subjects
  • Have a cerebrovascular accident diagnosis at least 6 months prior to study enrollment
  • Age 45-85
  • Can comprehend English
  • Have an internet connection in the home
  • Mini Mental Status Examination score > 24 (no more than mild cognitive deficits)
  • Mild to moderate motor deficits (range of motion screening- > 45 degrees shoulder flexion, some wrist movement, partial extension of the fingers)
  • Functional balance (Berg Balance Scale score > 45)
  • Caregivers:
  • 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.
  • Over the age of 18
  • Can comprehend English

Exclusion criteria

  • Stroke Subject:
  • A medical condition that prevents interaction with a television or video games
  • Receiving occupational or physical therapy services at the time of study involvement
  • Caregiver: NONE

Treatment and study plan

Virtual Reality Mystic Isle Game

Behavioral

8 week virtual reality based exercise program

Standard Home Exercise Program

Behavioral

8 week standard occupational therapy home exercise program

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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

  4. 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)

  5. 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).

  6. Mini-Mental Status Examination

    Time frame: Screening

    Questionnaire used to measure cognitive impairment

  7. Demographic and Health History Questionnaire

    Time frame: Baseline assessment

    Includes questions related to demographics and health history

  8. 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

  9. Range of Motion Screening

    Time frame: Screening

    Participant will be screened to see if they have the minimal movement at the shoulder and elbow.

  10. Berg Balance Scale

    Time frame: Screening

    Assessment of balance ability. Score range is 0-56. Cut-off for screening is 45

  11. 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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