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

Stroke Clinical Trial

— STARS  

Official title:

The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905917
• Other study ID #: The STARS Study
• Status: Completed
• Phase: N/A
• First received: July 18, 2013
• Last updated: September 12, 2017
• Start date: November 2013
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Tele-rehabilitation

Locations

Country	Name	City	State
Singapore	Ang Mo Kio Thye Hua Kwan Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
National University, Singapore	Ang Mo Kio Thye Hua Kwan Hospital, Singapore General Hospital, Singapore Millennium Foundation

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gait speed	Gait speed	3 & 6 months
Other	Two-Minute Walk test	Two-Minute Walk test	3 & 6 months
Other	Shah-modified Barthel Index	Shah-modified Barthel Index	3 & 6 months
Other	Activities-Specific Balance Confidence Scale	Activities-Specific Balance Confidence Scale	3 & 6 months
Other	Self-reported health-related quality-of-life using the Euro-QOL (EQ-5D)	Self-reported health-related quality-of-life using the Euro-QOL (EQ-5D)	3 & 6 months
Other	Health service utilization (perform cost-effectiveness analyses) using the Singapore Stroke Study Health Service Utilization Form	Health service utilization (perform cost-effectiveness analyses) using the Singapore Stroke Study Health Service Utilization Form	3 & 6 months
Other	Caregiver reported stress using the Zarit Caregiver Burden Inventory	Caregiver reported stress using the Zarit Caregiver Burden Inventory	3 & 6 months
Primary	Jette Late Life Functional and Disability Instrument (LLFDI)	Disability component of the Jette Late Life Functional and Disability Instrument (LLFDI)	3 months
Secondary	Jette Late Life Functional and Disability Instrument (LLFDI)	Disabiity component of Jette Late Life Functional and Disability Instrument (LLFDI)	6 months

External Links

•   Ang Mo Kio Thye Hua Kwan Hospital
•   Singapore Millennium Foundation