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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 National University, Singapore:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: November 2015 (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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905917

Contacts
Contact: Gerald CH Koh, MBBS, PhD +65-65164979 Gerald_Koh@nuhs.edu.sg
Contact: Angela Cheong, BSc +65-65168233 Angela_Cheong@nuhs.edu.sg

Locations
Singapore
Ang Mo Kio Thye Hua Kwan Hospital Recruiting
Singapore, Singapore, 569766
Contact: Carolina Png, MSc       Carolina_Png@amkh.org.sg   
Principal Investigator: Carolina Png, MSc         
Singapore General Hospital Not yet recruiting
Singapore, Singapore, 169608
Contact: Yee Sien Ng, FAMS    63213563    ng.yee.sien@sgh.com.sg   
Contact: Deidre DeSilva, FAMS       deidre.a.de.silva@sgh.com.sg   
Principal Investigator: Yee Sien Ng, FAMS         
Sub-Investigator: Deidre De Silva, FAMS         
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:
Responsible Party: Gerald Koh, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT01905917     History of Changes
Other Study ID Numbers: The STARS Study
Study First Received: July 18, 2013
Last Updated: September 29, 2014
Health Authority: Singapore: Institutional Review Board

Keywords provided by National University, Singapore:
Stroke

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

ClinicalTrials.gov processed this record on November 20, 2014