The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study: A Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- National University of Singapore
- Enrollment
- 124
- Locations
- 2
- Primary Endpoint
- Jette Late Life Functional and Disability Instrument (LLFDI)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 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.
Investigators
Gerald Koh
Associate Professor
National University of Singapore
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Jette Late Life Functional and Disability Instrument (LLFDI)
Time Frame: 3 months
Disability component of the Jette Late Life Functional and Disability Instrument (LLFDI)
Secondary Outcomes
- Jette Late Life Functional and Disability Instrument (LLFDI)(6 months)