Home-based Virtual Reality Training After Discharge From Hospital-based Stroke Rehabilitation: A Parallel Randomised Feasibility Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
Virtual reality (VR) training (VRT) uses computer software to track a user's movements and allow them to interact with a game presented on a TV. It is fun and engaging and may encourage the user to do more exercise. VRT is increasingly being used for rehabilitation after stroke. Patients often require ongoing therapy post-discharge from inpatient rehabilitation. Outpatient therapy may be unavailable due to waiting lists, transportation issues, distance etc.; therefore, home-based VRT may be the answer. Our objectives are to determine: 1) the feasibility of home-based VRT for stroke patients after discharge from hospital-based rehabilitation, and 2) the feasibility of a battery of outcome measures. Forty stroke rehabilitation patients will be recruited over 18 months and randomize them to experimental or control groups. VRT participants will be introduced to VRT at the hospital and a VRT system will be set up in their homes shortly after discharge. Control participants will be provided with games and apps on an iPad focusing on cognition and fine motor skills. Participants will be instructed to perform 30 minutes of VRT 5 days a week for 6 weeks. Training will be monitored remotely. Both groups will receive weekly phone calls to review their home activity and answer questions. Measurements will be made of standing balance and general function before and after training, and feasibility (compliance, enjoyment, safety).
详细描述
Stroke causes approximately 15 300 hospital admissions per year in Ontario and 50% of individuals who have had a stroke are left with moderate to severe impairment. Because of the severity of their condition, these individuals often cannot stand and have poor sitting and standing balance. Most patients who are discharged from inpatient stroke rehabilitation are 8-10 weeks post-stroke and have not completely recovered. Their brains are still in a period of enhanced neuroplasticity, during which great functional change can be made; Therapy outcomes are dose-dependent; intensive, high-repetition, task-oriented and task-specific therapies are most effective. Therefore, for the greatest recovery possible, these patients require ongoing therapy. Most are offered this on an outpatient basis. However, for many reasons (transportation difficulties, distance from downtown, weather etc.), not all eligible patients are able to attend outpatient therapy. Also, there is a waiting list and a limited number of outpatient therapy sessions are offered to each patient.
Virtual reality training (VRT) uses computer software to track the user's movements and allow him or her to interact with a game or activity presented on a TV screen. It is convenient, timely, and enjoyable, and may be done for an unlimited period post-stroke. VRT has been shown to benefit upper extremity function, standing balance, gait and overall function. Home-based VRT offers a promising addition or alternative to existing rehabilitation programs and home exercise programs that could make a significant difference in the lives of stroke survivors. A few pilot studies have investigated the use of home-based VRT for standing balance and upper extremity recovery after stroke and shown the feasibility of these systems for ongoing rehabilitation in the home. The investigators wish to expand on these studies by using a new VR system, made by Jintronix Inc. (Montreal, QC). This system was initially developed for stroke rehabilitation and has also been used extensively with healthy and frail elderly individuals. The Jintronix system is marketed for institutional and home use and has a simple-to-use interface but its home use has not yet been fully evaluated. The games are designed to incorporate motor learning principles such as multiple forms of feedback and task-specific practice that can be progressed to maintain an appropriate level of challenge. The purpose of this study is to investigate the feasibility, acceptance and safety of this new, simple-to-use VRT system used in the home, combined with substantial remote support for the user.
The primary objectives assessed the feasibility of using VRT in the home by patients post-stroke, using quantitative and qualitative methods. Specific objectives were:
- To estimate the recruitment rate of participants into the study;
- To assess the ability and compliance of the participants with respect to the components of the research protocol (ability to learn VRT through the training program; ability to comply with the exercise protocol; participant retention);
- To determine the safety of home-based VRT (presence of minor and major adverse events);
- To assess the ability of stroke survivors and their study partners to use VRT technology in the home (i.e. technical difficulties, difficulty learning the games);
- To assess the acceptability of the VRT intervention (enjoyment; perceived efficacy)
- To estimate the cost for a future definitive randomised control trial (RCT) on in-home VRT.
The secondary objectives assessed the feasibility of the outcome measures, using quantitative and qualitative methods. Specific objectives were:
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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor does not know the participant's intervention group allocation.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have had a stroke (ischemic or hemorrhagic) resulting in physical impairment;
- •have enough preserved cognitive ability to learn VRT
- •are receiving inpatient or outpatient stroke rehabilitation services;
- •are able to stand independently for at least 2 minutes
- •have a study partner who could attend 2 training sessions with the participant and was able to be in the home with the participant while doing VRT;
- •can read, speak and understand English;
- •live within 50 km of Élisabeth Bruyère Hospital;
- •are able and willing to attend 4 appointments at Élisabeth Bruyère Hospital (2 for assessment; 2 for training);
- •will not be travelling away from home for more than 2 days a week for the duration of the study;
- •have enough space in their home to do VRT safely.
排除标准
- •have an unstable medical condition, seizures or vertigo,
- •are unable to perform mild to moderate exercise safely.
研究组 & 干预措施
Virtual Reality
Virtual reality training designed to train standing balance, reaching, stepping, gentle strengthening and aerobic conditioning.
干预措施: Virtual reality (Device)
Control
iPad apps designed to train memory, cognition, visual tracking and fine motor skills.
干预措施: Control (Device)
结局指标
主要结局
Recruitment rate
时间窗: 18 months
number of participants recruited over 18 months of participant intake relative to the number who met study criteria and number who were approached
Quantitative assessment of ability and compliance to research protocol
时间窗: 18 months
assessed by monitoring the use and progression of the VRT program
Qualitative assessment of ability and compliance to research protocol
时间窗: 18 months
assessed through comments made by the participant and study partner
Adverse events (incidence & type) due to home-based VRT intervention
时间窗: 18 months
presence of adverse effects (minor and severe) recorded from telephone conversations and through log book
Ability to use VRT in the home
时间窗: 18 months
assessed through comments made by the participant and study partner
Quantitative assessment of acceptability of VRT intervention
时间窗: 18 months
assessed with the Physical Activity Enjoyment Scale
Qualitative assessment of acceptability of VRT intervention
时间窗: 18 months
assessed through comments made by the participant and study partner
Estimate cost for a future definitive RCT
时间窗: 18 months
calculate costs of all components of this study
次要结局
- Ability of participants to perform Berg Balance Scale without quitting due to fatigue or frustration(18 months)
- Ability of participants to perform Timed Up & Go (original version) without quitting due to fatigue or frustration(18 months)
- Ability of participants to perform Timed Up & Go (manual version) without quitting due to fatigue or frustration(18 months)
- Ability of participants to perform Timed Up & Go (cognitive version) without quitting due to fatigue or frustration(18 months)
- Ability of participants to perform Five Times Sit-to-Stand without quitting due to fatigue or frustration(18 months)
- Ability of participants to perform Community Balance & Mobility Scale without quitting due to fatigue or frustration(18 months)
- Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (cognitive version)(18 months)
- Potential for home-based VRT to maintain or improve performance on the Five Times Sit-To-Stand Test(18 months)
- Potential for home-based VRT to maintain or improve performance on the Community Balance and Mobility Scale(18 months)
- Ability of participants to perform quantitative analysis of quiet stance in standing without quitting due to fatigue or frustration(18 months)
- Ability of participants to perform quantitative analysis of limits of stability in standing without quitting due to fatigue or frustration(18 months)
- Potential for home-based VRT to maintain or improve performance on the Berg Balance Scale(18 months)
- Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (original version)(18 months)
- Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (manual version)(18 months)
- Potential for home-based VRT to maintain or improve performance on quantitative analyses of quiet stance and limits of stability in standing(18 months)
- Potential for home-based VRT to maintain or improve performance on the Stroke Impact Scale(18 months)
- Potential for home-based VRT to maintain or improve performance on the Reintegration to Normal Living Index(18 months)
- Determine a sample size for a definitive RCT on home-based VRT(18 months)
