Game-Based Home Exercise Programs in Chronic Stroke: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change from baseline in the Canadian Occupational Performance Measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke Subjects
- •Have a cerebrovascular accident diagnosis at least 6 months prior to study enrollment
- •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
排除标准
- •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
研究组 & 干预措施
Virtual Reality Mystic Isle Game
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.
干预措施: Virtual Reality Mystic Isle Game (Behavioral)
Standard Home Exercise Program
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.
干预措施: Standard Home Exercise Program (Behavioral)
结局指标
主要结局
Change from baseline in the Canadian Occupational Performance Measure
时间窗: 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.
次要结局
- Change from baseline in the bicep strength(Baseline, 8 weeks)
- Change from baseline in the range of motion of shoulder(Baseline, 8 weeks)
- Mini-Mental Status Examination(Screening)
- Demographic and Health History Questionnaire(Baseline assessment)
- Intrinsic Motivation Inventory(8 weeks)
- Range of Motion Screening(Screening)
- 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 PROMIS-29(Baseline, 8 weeks)
- Berg Balance Scale(Screening)
- Change from baseline in the Fugl-Meyer Assessment - Upper Extremity(Baseline, 8 weeks)
研究者
Rachel Proffitt
Assistant Professor, Occupational Therapy
University of Missouri-Columbia