NCT Number: NCT01905917
The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study
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.
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Notify MeKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Ang Mo Kio Thye Hua Kwan Hospital, Singapore
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
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)
Time frame: 6 months
Disabiity component of Jette Late Life Functional and Disability Instrument (LLFDI)
Other outcomes
-
Gait speed
Time frame: 3 & 6 months
Gait speed
-
Two-Minute Walk test
Time frame: 3 & 6 months
Two-Minute Walk test
-
Shah-modified Barthel Index
Time frame: 3 & 6 months
Shah-modified Barthel Index
-
Activities-Specific Balance Confidence Scale
Time frame: 3 & 6 months
Activities-Specific Balance Confidence Scale
-
Self-reported health-related quality-of-life using the Euro-QOL (EQ-5D)
Time frame: 3 & 6 months
Self-reported health-related quality-of-life using the Euro-QOL (EQ-5D)
-
Health service utilization (perform cost-effectiveness analyses) using the Singapore Stroke Study Health Service Utilization Form
Time frame: 3 & 6 months
Health service utilization (perform cost-effectiveness analyses) using the Singapore Stroke Study Health Service Utilization Form
-
Caregiver reported stress using the Zarit Caregiver Burden Inventory
Time frame: 3 & 6 months
Caregiver reported stress using the Zarit Caregiver Burden Inventory
Sponsors and collaborators
Lead sponsor
National University of Singapore
Other
Collaborators
- Ang Mo Kio - Thye Hua Kwan Hospital
- Singapore General Hospital
- Singapore Millennium Foundation
Registry information
Official study title
The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study: A Randomized Controlled Trial
Acronym: STARS
Important dates
- Study start
- 2013
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jul 23, 2013
- Registry last updated
- Sep 13, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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