Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial: protocol of a randomized clinical trial on tele-rehabilitation for stroke patients.
BACKGROUND
Most acute stroke patients with disabilities do not receive recommended rehabilitation following discharge to the community. Functional and social barriers are common reasons for non-adherence to post-discharge rehabilitation. Home rehabilitation is an alternative to centre-based rehabilitation but is costlier. Tele-rehabilitation is a possible solution, allowing for remote supervision of rehabilitation and eliminating access barriers. The objective of the Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial is to determine if a novel tele-rehabilitation intervention for the first three months after stroke admission improves functional recovery compared to usual care.


METHODS
This is a single blind (evaluator blinded), parallel, two-arm randomised controlled trial study design involving 100 recent stroke patients. The inclusion criteria are age ≥40 years, having caregiver support and recent stroke defined as stroke diagnosis within 4 weeks. Consenting participants will be randomized with varying block size of 4 or 6 assuming a 1:1 treatment allocation with the participating centre as the stratification factor. The baseline assessment will be done within 4 weeks of stroke onset, followed by follow-up assessments at 3 and 6 months. The tele-rehabilitation intervention lasts for 3 months and includes exercise 5-days-a-week using an iPad-based system that allows recording of daily exercise with video and sensor data and weekly video-conferencing with tele-therapists after data review. Those allocated to the control group will receive usual care. The primary outcome measure is improvement in life task's social activity participation at three months as measured by the disability component of the Jette Late Life Functional and Disability Instrument (LLFDI). Secondary outcome variables consist of gait speed (Timed 5-Meter Walk Test) and endurance (Two-Minute Walk test), performance of basic activities of daily living (Shah-modified Barthel Index), balance confidence (Activities-Specific Balance Confidence Scale), patient self-reported health-related quality-of-life [Euro-QOL (EQ-5D)], health service utilization (Singapore Stroke Study Health Service Utilization Form) and caregiver reported stress (Zarit Caregiver Burden Inventory).


CONCLUSIONS
The goal of this trial is to provide evidence on the potential benefit and cost-effectiveness of this novel tele-rehabilitation programme which will guide health care decision-making and potentially improve performance of post-stroke community-based rehabilitation.


BACKGROUND
This trial protocol was registered under ClinicalTrials.gov on 18 July 2013 as study title "The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study" (ID: The STARS Study, ClinicalTrials.gov Identifier: NCT01905917 ).
Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, #10-03-G, Tahir Foundation Building, Block MD1, 12 Science Drive 2, Singapore, 117549, Singapore. Gerald_Koh@nuhs.edu.sg.|Yong Loo Lin School of Medicine, National University of Singapore, National University Health System, Singapore, Singapore. Gerald_Koh@nuhs.edu.sg.
Gerald Choon-Huat
GC
Koh
Department of Electrical and Computer Engineering, National University of Singapore, Singapore, Singapore. shihcheng@nus.edu.sg.
Shih Cheng
SC
Yen
Department of Electrical and Computer Engineering, National University of Singapore, Singapore, Singapore. arthurtay@nus.edu.sg.
Arthur
A
Tay
Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, #10-03-G, Tahir Foundation Building, Block MD1, 12 Science Drive 2, Singapore, 117549, Singapore. angela_cheong@nuhs.edu.sg.|Yong Loo Lin School of Medicine, National University of Singapore, National University Health System, Singapore, Singapore. angela_cheong@nuhs.edu.sg.
Angela
A
Cheong
Singapore General Hospital, Singapore, Singapore. ng.yee.sien@sgh.com.sg.
Yee Sien
YS
Ng
National Neuroscience Institute, Singapore General Hospital campus, Singapore, Singapore. gnrdsd@sgh.com.sg.
Deidre Anne
DA
De Silva
Ang Mo Kio Thye Hua Kwan Hospital, Singapore, Singapore. Carolina_Png@amkh.org.sg.
Carolina
C
Png
Department of Surgery, Medicine and Biomedical Engineering, Duke University, Durham, USA. kevin.caves@duke.edu.
Kevin
K
Caves
Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, #10-03-G, Tahir Foundation Building, Block MD1, 12 Science Drive 2, Singapore, 117549, Singapore. karenkoh7@gmail.com.
Karen
K
Koh
Department of Electrical and Computer Engineering, National University of Singapore, Singapore, Singapore. yoga.nus@gmail.com.
Yogaprakash
Y
Kumar
Department of Electrical and Computer Engineering, National University of Singapore, Singapore, Singapore. phan@nus.edu.sg.
Shi Wen
SW
Phan
Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, #10-03-G, Tahir Foundation Building, Block MD1, 12 Science Drive 2, Singapore, 117549, Singapore. bee_choo_tai@nuhs.edu.sg.
Bee Choo
BC
Tai
Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, #10-03-G, Tahir Foundation Building, Block MD1, 12 Science Drive 2, Singapore, 117549, Singapore. cynthiachen@u.nus.edu.
Cynthia
C
Chen
Department of Rehabilitation Medicine, National University Hospital, Singapore, Singapore. effie_chew@nuhs.edu.sg.
Effie
E
Chew
Investigational Medicine Unit, National University Health System, Singapore, Singapore. medcz@nus.edu.sg.
Zhaojin
Z
Chao
Yong Loo Lin School of Medicine, National University of Singapore, National University Health System, Singapore, Singapore. A0102238@nus.edu.sg.
Chun En
CE
Chua
Department of Biological Science, National University of Singapore, Singapore, Singapore. koh.yen.sin91@nus.edu.sg.
Yen Sin
YS
Koh
Physical Medicine & Rehabilitation Service, Durham Veterans Affairs Medical Centre, Durham, USA. helen.hoenig@va.gov.
Helen
H
Hoenig
D000203:Activities of Daily Living; D000328:Adult; D004185:Disability Evaluation; D020233:Gait Disorders, Neurologic / Q000534:rehabilitation; D006801:Humans; D011788:Quality of Life; D020127:Recovery of Function; D012846:Singapore; D016037:Single-Blind Method; D058992:Social Participation; D000071939:Stroke Rehabilitation; D000069350:Telerehabilitation