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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National University, Singapore
Sponsor:
Collaborators:
Singapore Millennium Foundation
Singapore General Hospital
Ang Mo Kio Thye Hua Kwan Hospital
Information provided by (Responsible Party):
Gerald Koh, National University, Singapore
ClinicalTrials.gov Identifier:
NCT01905917
First received: July 18, 2013
Last updated: September 29, 2014
Last verified: September 2014

July 18, 2013
September 29, 2014
November 2013
November 2015   (final data collection date for primary outcome measure)
Jette Late Life Functional and Disability Instrument (LLFDI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Disability component of the Jette Late Life Functional and Disability Instrument (LLFDI)
Same as current
Complete list of historical versions of study NCT01905917 on ClinicalTrials.gov Archive Site
Jette Late Life Functional and Disability Instrument (LLFDI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Disabiity component of Jette Late Life Functional and Disability Instrument (LLFDI)
Same as current
  • Gait speed [ Time Frame: 3 & 6 months ] [ Designated as safety issue: No ]
    Gait speed
  • Two-Minute Walk test [ Time Frame: 3 & 6 months ] [ Designated as safety issue: No ]
    Two-Minute Walk test
  • Shah-modified Barthel Index [ Time Frame: 3 & 6 months ] [ Designated as safety issue: No ]
    Shah-modified Barthel Index
  • Activities-Specific Balance Confidence Scale [ Time Frame: 3 & 6 months ] [ Designated as safety issue: Yes ]
    Activities-Specific Balance Confidence Scale
  • Self-reported health-related quality-of-life using the Euro-QOL (EQ-5D) [ Time Frame: 3 & 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Caregiver reported stress using the Zarit Caregiver Burden Inventory
Same as current
 
The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study
The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study: A Randomized Controlled Trial

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
Other: Tele-rehabilitation
  • No Intervention: Control
    Usual care
  • Experimental: 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.
    Intervention: Other: Tele-rehabilitation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
February 2016
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age ≥ 40 years;
  2. Recent stroke (defined as stroke symptoms occurring within 4 weeks prior to admission into community hospitals);
  3. Diagnosis of stroke made by clinician and/or supported by brain imaging;
  4. Able to sit unsupported for 30 seconds;
  5. Able to stand on the non-paretic leg for >4 sec;
  6. Able to walk at least 2m with maximum of 1 person assist;
  7. Able to follow a 3-step command;
  8. Living in the community before discharge and expected to be discharged home;
  9. Has a caregiver.

Exclusion Criteria:

  1. Has a pacemaker in-situ (because of possible interference of pacemakers by wireless electronic signals);
  2. Unable to ambulate at least 150 feet prior to stroke, or intermittent claudication while walking less than 200 meters;
  3. 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);
  4. History of serious chronic obstructive pulmonary disease or oxygen dependence;
  5. Severe weight bearing pain;
  6. Pre-existing neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS) or severe dementia
  7. History of major head trauma with severe residual deficits;
  8. Lower extremity amputation;
  9. Legal blindness or severe visual impairment;
  10. Severe uncontrolled psychiatric illness such as psychosis, schizophrenia or medication refractory depression;
  11. Life expectancy less than three months;
  12. 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°);
  13. History of sustained alcoholism or drug abuse in the last six months;
  14. 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.
Both
40 Years and older
No
Contact: Gerald CH Koh, MBBS, PhD +65-65164979 Gerald_Koh@nuhs.edu.sg
Contact: Angela Cheong, BSc +65-65168233 Angela_Cheong@nuhs.edu.sg
Singapore
 
NCT01905917
The STARS Study
No
Gerald Koh, National University, Singapore
National University, Singapore
  • Singapore Millennium Foundation
  • Singapore General Hospital
  • Ang Mo Kio Thye Hua Kwan Hospital
Principal Investigator: Shih-Cheng Yes, PhD National University, Singapore
Principal Investigator: Tay Arthur, PhD National University, Singapore
National University, Singapore
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP