The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- Jette Late Life Functional and Disability Instrument (LLFDI)
研究概览
简要总结
The primary hypothesis tested in this randomized control trial is that a tele-rehabilitation intervention involving video-conferencing with a therapist and use of wearable monitoring devices in the first three months after stroke results greater functional recovery using the Jette Late Life Functional and Disability Instrument (LLFDI) (primary outcome) among stroke at three months survivors compared to usual care.
The secondary hypotheses tested in this randomized control trial are that a tele-rehabilitation intervention involving video-conferencing with a therapist and use of wearable monitoring devices in the first three months after stroke results in:
- Functional recovery using the LLFDI at 6 months,
- Functional recovery using gait speed, 2-minute walk test and Shah modified Barthel Index at 3 and 6 months,
- Greater contact time with a therapist at 3 & 6 months,
- Better balance at 3 & 6 months,
- Better self-report health-related quality of life at 3 & 6 months,
- Decreased health service utilization at 3 & 6 months,
- Reduced caregiver burden at three months survivors compared to usual care at 3 & 6 months.
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)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years;
- •Recent stroke (defined as stroke symptoms occurring within 4 weeks prior to admission into community hospitals);
- •Diagnosis of stroke made by clinician and/or supported by brain imaging;
- •Able to sit unsupported for 30 seconds;
- •Able to stand on the non-paretic leg for >4 sec;
- •Able to walk at least 2m with maximum of 1 person assist;
- •Able to follow a 3-step command;
- •Living in the community before discharge and expected to be discharged home;
- •Has a caregiver.
排除标准
- •Has a pacemaker in-situ (because of possible interference of pacemakers by wireless electronic signals);
- •Unable to ambulate at least 150 feet prior to stroke, or intermittent claudication while walking less than 200 meters;
- •Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of severe congestive heart failure, serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living);
- •History of serious chronic obstructive pulmonary disease or oxygen dependence;
- •Severe weight bearing pain;
- •Pre-existing neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS) or severe dementia
- •History of major head trauma with severe residual deficits;
- •Lower extremity amputation;
- •Legal blindness or severe visual impairment;
- •Severe uncontrolled psychiatric illness such as psychosis, schizophrenia or medication refractory depression;
- •Life expectancy less than three months;
- •Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of > 10°, knee flexion ROM < 90°, hip flexion contracture > 25°, and ankle plantar flexion contracture > 15°);
- •History of sustained alcoholism or drug abuse in the last six months;
- •Hypertension with systolic blood pressure greater than 200 mmHg and diastolic blood pressure greater than 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg.
研究组 & 干预措施
Control
Usual care
Tele-Rehabilitation
A tele-rehabilitation intervention involving weekly video-conferencing with a therapist, training exercise videos and use of wearable sensors to capture patient participation in exercises.
干预措施: Tele-rehabilitation (Other)
结局指标
主要结局
Jette Late Life Functional and Disability Instrument (LLFDI)
时间窗: 3 months
Disability component of the Jette Late Life Functional and Disability Instrument (LLFDI)
次要结局
- Jette Late Life Functional and Disability Instrument (LLFDI)(6 months)
研究者
Gerald Koh
Associate Professor
National University of Singapore