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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Tele-rehabilitation
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Singapore General Hospital
  • Ang Mo Kio Thye Hua Kwan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Tele-Rehabilitation

Arm Description

Usual care

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.

Outcomes

Primary Outcome Measures

Jette Late Life Functional and Disability Instrument (LLFDI)
Disability component of the Jette Late Life Functional and Disability Instrument (LLFDI)

Secondary Outcome Measures

Jette Late Life Functional and Disability Instrument (LLFDI)
Disabiity component of Jette Late Life Functional and Disability Instrument (LLFDI)

Full Information

First Posted
July 18, 2013
Last Updated
September 12, 2017
Sponsor
National University of Singapore
Collaborators
Singapore Millennium Foundation, Singapore General Hospital, Ang Mo Kio - Thye Hua Kwan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01905917
Brief Title
The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study
Acronym
STARS
Official Title
The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
Singapore Millennium Foundation, Singapore General Hospital, Ang Mo Kio - Thye Hua Kwan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Tele-Rehabilitation
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Tele-rehabilitation
Primary Outcome Measure Information:
Title
Jette Late Life Functional and Disability Instrument (LLFDI)
Description
Disability component of the Jette Late Life Functional and Disability Instrument (LLFDI)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Jette Late Life Functional and Disability Instrument (LLFDI)
Description
Disabiity component of Jette Late Life Functional and Disability Instrument (LLFDI)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Gait speed
Description
Gait speed
Time Frame
3 & 6 months
Title
Two-Minute Walk test
Description
Two-Minute Walk test
Time Frame
3 & 6 months
Title
Shah-modified Barthel Index
Description
Shah-modified Barthel Index
Time Frame
3 & 6 months
Title
Activities-Specific Balance Confidence Scale
Description
Activities-Specific Balance Confidence Scale
Time Frame
3 & 6 months
Title
Self-reported health-related quality-of-life using the Euro-QOL (EQ-5D)
Description
Self-reported health-related quality-of-life using the Euro-QOL (EQ-5D)
Time Frame
3 & 6 months
Title
Health service utilization (perform cost-effectiveness analyses) using the Singapore Stroke Study Health Service Utilization Form
Description
Health service utilization (perform cost-effectiveness analyses) using the Singapore Stroke Study Health Service Utilization Form
Time Frame
3 & 6 months
Title
Caregiver reported stress using the Zarit Caregiver Burden Inventory
Description
Caregiver reported stress using the Zarit Caregiver Burden Inventory
Time Frame
3 & 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Cheng Yes, PhD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tay Arthur, PhD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Ang Mo Kio Thye Hua Kwan Hospital
City
Singapore
ZIP/Postal Code
569766
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
21612471
Citation
Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK, Cen S, Hayden SK; LEAPS Investigative Team. Body-weight-supported treadmill rehabilitation after stroke. N Engl J Med. 2011 May 26;364(21):2026-36. doi: 10.1056/NEJMoa1010790.
Results Reference
background
PubMed Identifier
17996052
Citation
Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39.
Results Reference
background
PubMed Identifier
22627983
Citation
Chumbler NR, Quigley P, Li X, Morey M, Rose D, Sanford J, Griffiths P, Hoenig H. Effects of telerehabilitation on physical function and disability for stroke patients: a randomized, controlled trial. Stroke. 2012 Aug;43(8):2168-74. doi: 10.1161/STROKEAHA.111.646943. Epub 2012 May 24.
Results Reference
background
PubMed Identifier
26341358
Citation
Koh GC, Yen SC, Tay A, Cheong A, Ng YS, De Silva DA, Png C, Caves K, Koh K, Kumar Y, Phan SW, Tai BC, Chen C, Chew E, Chao Z, Chua CE, Koh YS, Hoenig H. Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial: protocol of a randomized clinical trial on tele-rehabilitation for stroke patients. BMC Neurol. 2015 Sep 5;15:161. doi: 10.1186/s12883-015-0420-3.
Results Reference
derived
Links:
URL
http://www.amkh.com.sg/
Description
Ang Mo Kio Thye Hua Kwan Hospital

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

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