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

Primary Purpose

Chronic Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Mystic Isle Game
Standard Home Exercise Program
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Upper Extremity Hemiparesis, Virtual Reality (VR)

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Mystic Isle Game

Standard Home Exercise Program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in the Canadian Occupational Performance Measure
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

Change from baseline in the Performance Assessment of Self-Care Skills
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 Modified Ashworth Scale
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
Angle (degrees) of the shoulder joint as measured by a goniometer
Change from baseline in the bicep strength
Muscle strength of the biceps muscle as measured by manual muscle testing (scale 0-5)
Change from baseline in the PROMIS-29
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
Questionnaire used to measure cognitive impairment
Demographic and Health History Questionnaire
Includes questions related to demographics and health history
Intrinsic Motivation Inventory
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
Participant will be screened to see if they have the minimal movement at the shoulder and elbow.
Berg Balance Scale
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
Assessment of upper extremity function post-stroke. Scale ranges from 0-66.

Full Information

First Posted
April 26, 2018
Last Updated
October 9, 2018
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03531567
Brief Title
Game-Based Home Exercise Programs in Chronic Stroke: A Feasibility Study
Official Title
Game-Based Home Exercise Programs in Chronic Stroke: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
Upper Extremity Hemiparesis, Virtual Reality (VR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Mystic Isle Game
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Home Exercise Program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Mystic Isle Game
Intervention Description
8 week virtual reality based exercise program
Intervention Type
Behavioral
Intervention Name(s)
Standard Home Exercise Program
Intervention Description
8 week standard occupational therapy home exercise program
Primary Outcome Measure Information:
Title
Change from baseline in the Canadian Occupational Performance Measure
Description
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.
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the Performance Assessment of Self-Care Skills
Description
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.
Time Frame
Baseline, 8 weeks
Title
Change from baseline in the Modified Ashworth Scale
Description
Assess muscle tone of various joints. Only joints with any spasticity will be recorded. Scale ranges from 0 (no spasticity) to 3 (rigid joint).
Time Frame
Baseline, 8 weeks
Title
Change from baseline in the range of motion of shoulder
Description
Angle (degrees) of the shoulder joint as measured by a goniometer
Time Frame
Baseline, 8 weeks
Title
Change from baseline in the bicep strength
Description
Muscle strength of the biceps muscle as measured by manual muscle testing (scale 0-5)
Time Frame
Baseline, 8 weeks
Title
Change from baseline in the PROMIS-29
Description
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).
Time Frame
Baseline, 8 weeks
Title
Mini-Mental Status Examination
Description
Questionnaire used to measure cognitive impairment
Time Frame
Screening
Title
Demographic and Health History Questionnaire
Description
Includes questions related to demographics and health history
Time Frame
Baseline assessment
Title
Intrinsic Motivation Inventory
Description
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
Time Frame
8 weeks
Title
Range of Motion Screening
Description
Participant will be screened to see if they have the minimal movement at the shoulder and elbow.
Time Frame
Screening
Title
Berg Balance Scale
Description
Assessment of balance ability. Score range is 0-56. Cut-off for screening is 45
Time Frame
Screening
Title
Change from baseline in the Fugl-Meyer Assessment - Upper Extremity
Description
Assessment of upper extremity function post-stroke. Scale ranges from 0-66.
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
26673558
Citation
Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available. Erratum In: Circulation. 2016 Apr 12;133(15):e599.
Results Reference
background
PubMed Identifier
21642065
Citation
Jurkiewicz MT, Marzolini S, Oh P. Adherence to a home-based exercise program for individuals after stroke. Top Stroke Rehabil. 2011 May-Jun;18(3):277-84. doi: 10.1310/tsr1803-277.
Results Reference
background
PubMed Identifier
19635344
Citation
Morris JH, Williams B. Optimising long-term participation in physical activities after stroke: exploring new ways of working for physiotherapists. Physiotherapy. 2009 Sep;95(3):228-34. doi: 10.1016/j.physio.2008.11.006. Epub 2009 Jan 29.
Results Reference
background
PubMed Identifier
22974010
Citation
Nicholson S, Sniehotta FF, van Wijck F, Greig CA, Johnston M, McMurdo ME, Dennis M, Mead GE. A systematic review of perceived barriers and motivators to physical activity after stroke. Int J Stroke. 2013 Jul;8(5):357-64. doi: 10.1111/j.1747-4949.2012.00880.x. Epub 2012 Sep 13.
Results Reference
background
PubMed Identifier
21474804
Citation
Saposnik G, Levin M; Outcome Research Canada (SORCan) Working Group. Virtual reality in stroke rehabilitation: a meta-analysis and implications for clinicians. Stroke. 2011 May;42(5):1380-6. doi: 10.1161/STROKEAHA.110.605451. Epub 2011 Apr 7.
Results Reference
background
PubMed Identifier
27563384
Citation
Proffitt R, Lange B. Feasibility of a Customized, In-Home, Game-Based Stroke Exercise Program Using the Microsoft Kinect(R) Sensor. Int J Telerehabil. 2015 Nov 20;7(2):23-34. doi: 10.5195/ijt.2015.6177. eCollection 2015 Fall.
Results Reference
background
PubMed Identifier
30157019
Citation
Proffitt RM, Henderson W, Scholl S, Nettleton M. Lee Silverman Voice Treatment BIG(R) for a Person With Stroke. Am J Occup Ther. 2018 Sep/Oct;72(5):7205210010p1-7205210010p6. doi: 10.5014/ajot.2018.028217.
Results Reference
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PubMed Identifier
20814005
Citation
Wolf SL, Thompson PA, Winstein CJ, Miller JP, Blanton SR, Nichols-Larsen DS, Morris DM, Uswatte G, Taub E, Light KE, Sawaki L. The EXCITE stroke trial: comparing early and delayed constraint-induced movement therapy. Stroke. 2010 Oct;41(10):2309-15. doi: 10.1161/STROKEAHA.110.588723. Epub 2010 Sep 2.
Results Reference
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Game-Based Home Exercise Programs in Chronic Stroke: A Feasibility Study

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