The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study

Study Overview
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Brief Summary
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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.

Official Title
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The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study: A Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Other: Tele-rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care | |
| Experimental: Tele-Rehabilitation<br>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. | Other: Tele-rehabilitation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jette Late Life Functional and Disability Instrument (LLFDI) | Disability component of the Jette Late Life Functional and Disability Instrument (LLFDI) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jette Late Life Functional and Disability Instrument (LLFDI) | Disabiity component of Jette Late Life Functional and Disability Instrument (LLFDI) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke