Clinical trial NCT03531567: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Keywords: Upper Extremity Hemiparesis
Virtual Reality (VR)
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 8
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the Canadian Occupational Performance Measure
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change from baseline in the Performance Assessment of Self-Care Skills
timeFrame: Baseline, 8 weeks
measure: Change from baseline in the Modified Ashworth Scale
timeFrame: Baseline, 8 weeks
measure: Change from baseline in the range of motion of shoulder
timeFrame: Baseline, 8 weeks
measure: Change from baseline in the bicep strength
timeFrame: Baseline, 8 weeks
measure: Change from baseline in the PROMIS-29
timeFrame: Baseline, 8 weeks
measure: Mini-Mental Status Examination
timeFrame: Screening
measure: Demographic and Health History Questionnaire
timeFrame: Baseline assessment
measure: Intrinsic Motivation Inventory
timeFrame: 8 weeks
measure: Range of Motion Screening
timeFrame: Screening
measure: Berg Balance Scale
timeFrame: Screening
measure: Change from baseline in the Fugl-Meyer Assessment - Upper Extremity
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
References:
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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.
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.
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.
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.
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