THE LOGISTICS OF COLLABORATING ON LARGE CLINICAL TRIALS INVOLVING PEOPLE WITH SPINAL CORD INJURIES ACROSS ASIA

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Chen LW1,2,3, Glinsky JV2,3, Kataria C4, Islam MS5, Boswell-Ruys C6, Denis S6, Redhead J7, Gollan E8, Ben M9, Hossain MM5, Chaudhary L4, Xiong Y10, Gandevia SC11, Harvey LA2,3
1Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia, 2John Walsh Centre for Rehabilitation Research, Kolling Institute, Northern Sydney Local Health District, St Leonards, NSW, Australia, 3Sydney Medical School Northern, University of Sydney, Sydney, Australia, 4Indian Spinal Injuries Centre, New Delhi, India, 5Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh, 6Prince of Wales Hospital, Randwick, NSW, Australia, 7Royal Rehab, Ryde, NSW, Australia, 8Queensland Spinal Injuries Service, Metro South Health, Brisbane, Australia, 9NSW Spinal Outreach Service, Ryde, NSW, Australia, 10Guangdong Work Injury Rehabilitation Hospital, Guangdong, China, 11Neuroscience Research Australia and University of New South Wales, Randwick, NSW, Australia

Background: To date, there are approximately 150 trials examining the effectiveness of different physiotherapy interventions for the management of people with spinal cord injuries. However, the results of most trials are inconclusive due to an insufficient sample size. We therefore need to be collaborating internationally across multiple sites to run large trials that can provide definitive answers and help develop a strong evidence base for clinical practice.

Purpose: To collaborate with multiple physiotherapy teams on a large pragmatic randomised controlled trial at spinal cord injuries units across Asia. The trial was designed to determine the effectiveness of 200 repetitions of contractions per day for 8 weeks on muscle strength in people with recent spinal cord injuries.

Methods: Over a 1-year period we have set up a trial at 5 spinal cord injury units in Australia, Bangladesh, India and China with the plan to recruit 120 people. The trial was designed to be collaborative across all sites with a physiotherapy intervention that is commonly and easily administered.

Results: All sites have successfully contributed to the trial. Recruitment began 18 months ago. To date, 725 participants have been screened, with 103 participants recruited. Eighty-two people have completed the trial. We have administered 952 treatments and collected 748 outcomes so far with only 2 drop-outs.

Conclusion(s): We are one of the first physiotherapy teams to conduct a multi-centred trial across 4 countries in our region involving people with spinal cord injuries. This type of collaboration is particularly challenging because of differences in language, healthcare systems and prior research experience. We have overcome these barriers through good communication, ongoing training and regular site monitoring. We have proven that research collaboration across very different countries in our region is possible.

Implications: Ongoing international collaboration amongst spinal cord injuries units is vital for ensuring we can conduct the large and adequately powered studies required to develop a strong evidence base for physiotherapy practice.

Keywords: Spinal Cord Injury, Rehabilitation, Physical Therapy

Funding acknowledgements: icare and The Slater and Gordon Foundation

Topic: Neurology; Disability & rehabilitation

Ethics approval required: Yes
Institution: Northern Sydney Local Health District
Ethics committee: Northern Sydney Local Health District Human Research Ethics Committee
Ethics number: HREC/16/HAWKE/251


All authors, affiliations and abstracts have been published as submitted.

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