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

Chronic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531567
• Other study ID #: 2008940
• Status: Completed
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2018
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Behavioral:
• Virtual Reality Mystic Isle Game
8 week virtual reality based exercise program
• Standard Home Exercise Program
8 week standard occupational therapy home exercise program

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. Review. — View Citation

Proffitt R, Henderson W, Scholl S, Nettleton M. Lee Silverman Voice Treatment- BIG® to improve occupational performance in stroke. American Journal of Occupational Therapy. In press.

Proffitt R, Lange B. Feasibility of a Customized, In-Home, Game-Based Stroke Exercise Program Using the Microsoft Kinect® Sensor. Int J Telerehabil. 2015 Nov 20;7(2):23-34. doi: 10.5195/ijt.2015.6177. eCollection 2015 Fall. — View 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. — View 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. — View Citation

Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jiménez 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. Erratum in: Circulation. 2016 Apr 12;133(15):e599. — View Citation

Outcome

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