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

NCT03531567 | Completed

• 1 other identifier: 2008940
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Keywords

Upper Extremity Hemiparesis; Virtual Reality (VR)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change from baseline in the Performance Assessment of Self-Care Skills

  Baseline, 8 weeks

• Change from baseline in the Modified Ashworth Scale

  Baseline, 8 weeks

• Change from baseline in the range of motion of shoulder

  Baseline, 8 weeks

• Change from baseline in the bicep strength

  Baseline, 8 weeks

• Change from baseline in the PROMIS-29

  Baseline, 8 weeks

Study Arms (2)

Virtual Reality Mystic Isle Game

EXPERIMENTAL

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

Standard Home Exercise Program

ACTIVE COMPARATOR

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

Interventions

Virtual Reality Mystic Isle Game BEHAVIORAL

8 week virtual reality based exercise program

Virtual Reality Mystic Isle Game

Standard Home Exercise Program BEHAVIORAL

8 week standard occupational therapy home exercise program

Standard Home Exercise Program

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (8)

• 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.

  PMID: 26673558 BACKGROUND

• 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.

  PMID: 21642065 BACKGROUND

• 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.

  PMID: 19635344 BACKGROUND

• 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.

  PMID: 22974010 BACKGROUND

• 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.

  PMID: 21474804 BACKGROUND

• 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.

  PMID: 27563384 BACKGROUND

• 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.

  PMID: 30157019 BACKGROUND

• 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.

  PMID: 20814005 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Occupational Therapy

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 21, 2018
• Study Start: September 21, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)