Status:
COMPLETED
The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study
Lead Sponsor:
National University of Singapore
Collaborating Sponsors:
Singapore Millennium Foundation
Singapore General Hospital
Conditions:
Stroke
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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 fi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01905917
Start Date
November 1 2013
End Date
September 1 2017
Last Update
September 13 2017
Active Locations (2)
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1
Singapore General Hospital
Singapore, Singapore, 169608
2
Ang Mo Kio Thye Hua Kwan Hospital
Singapore, Singapore, 569766