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Completed

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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Key information

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

Loading trial locations.

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

Tele-rehabilitation

Other

Primary outcomes

  1. 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

  1. 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

  1. Gait speed

    Time frame: 3 & 6 months

    Gait speed

  2. Two-Minute Walk test

    Time frame: 3 & 6 months

    Two-Minute Walk test

  3. Shah-modified Barthel Index

    Time frame: 3 & 6 months

    Shah-modified Barthel Index

  4. Activities-Specific Balance Confidence Scale

    Time frame: 3 & 6 months

    Activities-Specific Balance Confidence Scale

  5. 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)

  6. 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

  7. 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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