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

September 12, 2017 updated by: Gerald Koh, National University, Singapore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 569766
        • Ang Mo Kio Thye Hua Kwan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jette Late Life Functional and Disability Instrument (LLFDI)
Time Frame: 3 months
Disability component of the Jette Late Life Functional and Disability Instrument (LLFDI)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jette Late Life Functional and Disability Instrument (LLFDI)
Time Frame: 6 months
Disabiity component of Jette Late Life Functional and Disability Instrument (LLFDI)
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed
Time Frame: 3 & 6 months
Gait speed
3 & 6 months
Two-Minute Walk test
Time Frame: 3 & 6 months
Two-Minute Walk test
3 & 6 months
Shah-modified Barthel Index
Time Frame: 3 & 6 months
Shah-modified Barthel Index
3 & 6 months
Activities-Specific Balance Confidence Scale
Time Frame: 3 & 6 months
Activities-Specific Balance Confidence Scale
3 & 6 months
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)
3 & 6 months
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
3 & 6 months
Caregiver reported stress using the Zarit Caregiver Burden Inventory
Time Frame: 3 & 6 months
Caregiver reported stress using the Zarit Caregiver Burden Inventory
3 & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University, Singapore

Collaborators

Ang Mo Kio - Thye Hua Kwan Hospital
Singapore General Hospital
Singapore Millennium Foundation

Investigators

  • Principal Investigator: Shih-Cheng Yes, PhD, National University, Singapore
  • Principal Investigator: Tay Arthur, PhD, National University, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 22, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The STARS Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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