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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01905917
First Posted: July 23, 2013
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Singapore Millennium Foundation
Singapore General Hospital
Ang Mo Kio Thye Hua Kwan Hospital
Information provided by (Responsible Party):
Gerald Koh, National University, Singapore
  Purpose

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.

Condition Intervention
Stroke Other: Tele-rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Gerald Koh, National University, Singapore:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Jette Late Life Functional and Disability Instrument (LLFDI) [ Time Frame: 6 months ]
    Disabiity component of Jette Late Life Functional and Disability Instrument (LLFDI)


Other Outcome Measures:
  • 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


Enrollment: 124
Study Start Date: November 2013
Study Completion Date: September 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Tele-rehabilitation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905917


Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Ang Mo Kio Thye Hua Kwan Hospital
Singapore, Singapore, 569766
Sponsors and Collaborators
National University, Singapore
Singapore Millennium Foundation
Singapore General Hospital
Ang Mo Kio Thye Hua Kwan Hospital
Investigators
Principal Investigator: Shih-Cheng Yes, PhD National University, Singapore
Principal Investigator: Tay Arthur, PhD National University, Singapore
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerald Koh, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT01905917     History of Changes
Other Study ID Numbers: The STARS Study
First Submitted: July 18, 2013
First Posted: July 23, 2013
Last Update Posted: September 13, 2017
Last Verified: September 2017

Keywords provided by Gerald Koh, National University, Singapore:
Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases