Early and Intensive Motor Training for people with spinal cord injuries (the SCI-MT Trial): protocol of the process evaluation
Stephen Jan,
Catherine Sherrington,
Hueiming Liu,
Chris Bell,
Lisa A Harvey,
Sharon Roberts,
Joanne V Glinsky,
Jackie Chu,
Giorgio Scivoletto,
Marsha Ben,
Annemie I Spooren,
Lydia W Chen,
Fernanda Di Natal,
Federica Tamburella,
Vivien Jørgensen,
Emilie J Gollan,
Jacqui Agostinello,
Charlotte van Laake-Geelen,
Claire Lincoln,
Jessica van der Lede,
Janneke M Stolwijk,
Sue Paddison,
Donna Rainey,
Kristine M Oostra
Affiliations
Stephen Jan
The George Institute for Global Health, Newtown, New South Wales, Australia
Catherine Sherrington
Institute for Musculoskeletal Health, University of Sydney, Sydney, New South Wales, Australia
Hueiming Liu
The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
Chris Bell
Physiotherapy Department, Repat Health Precinct, Daw Park, South Australia, Australia
Lisa A Harvey
Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia
Sharon Roberts
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Joanne V Glinsky
John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, St Leonards, New South Wales, Australia
Jackie Chu
John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, The University of Sydney, Kolling Institute, Sydney, NSW, Australia
Giorgio Scivoletto
IRCCS, Santa Lucia Foundation, Rome, Italy
Marsha Ben
Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
Annemie I Spooren
REVAL, Hasselt University, Hasselt, Belgium
Lydia W Chen
Physiotherapy Department, Roayl North Shore Hospital, St Leonards, New South Wales, Australia
Fernanda Di Natal
Physiotherapy Department, Prince of Wales Hospital, Randwick, New South Wales, Australia
Federica Tamburella
IRCCS, Santa Lucia Foundation, Rome, Italy
Vivien Jørgensen
Research Department, Sunnaas Rehabilitation Hospital, Nesodden, Norway
Emilie J Gollan
Physiotherapy Department, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Jacqui Agostinello
Physiotherapy Department, Royal Talbot Rehabilitation Centre, Kew, Victoria, Australia
Charlotte van Laake-Geelen
Department of Rehabilitation Medicine, Research School CAPHRI, Maastricht University, Maastricht, The Netherlands
Claire Lincoln
Physiotherapy Department, Queen Elizabeth National Spinal Injuries Unit, Glasgow, Scotland
Jessica van der Lede
Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht Brain Center, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht, The Netherlands
Janneke M Stolwijk
Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht Brain Center, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht, The Netherlands
Sue Paddison
London Spinal Cord Injury Centre, Royal National Orthopaedic Hospital Trust, Stanmore, UK
Donna Rainey
Spinal Injury Unit, Royal Rehab, Ryde, New South Wales, Australia
Kristine M Oostra
Department of Physical Medicine and Rehabilitation, Ghent University Hospital, Ghent, Belgium
Introduction People with spinal cord injury receive physical rehabilitation to promote neurological recovery. Physical rehabilitation commences as soon as possible when a person is medically stable. One key component of physical rehabilitation is motor training. There is initial evidence to suggest that motor training can enhance neurological recovery if it is provided soon after injury and in a high dosage. The Early and Intensive Motor Training Trial is a pragmatic randomised controlled trial to determine whether 10 weeks of intensive motor training enhances neurological recovery for people with spinal cord injury. This pragmatic randomised controlled trial will recruit 220 participants from 15 spinal injury units in Australia, Scotland, Italy, Norway, England, Belgium and the Netherlands. This protocol paper describes the process evaluation that will run alongside the Early and Intensive Motor Training Trial. This process evaluation will help to explain the trial results and explore the potential facilitators and barriers to the possible future rollout of the trial intervention.Methods and analysis The UK Medical Research Council process evaluation framework and the Implementation Research Logic Model will be used to explain the trial outcomes and inform future implementation. Key components of the context, implementation and mechanism of impact, as well as the essential elements of the intervention and outcomes, will be identified and analysed. Qualitative and quantitative data will be collected and triangulated with the results of the Early and Intensive Motor Training Trial to strengthen the findings of this process evaluation.Ethics and dissemination Ethical approval for the Early and Intensive Motor Training Trial and process evaluation has been obtained from the Human Research Ethics Committee at the Northern Sydney Local Health District (New South Wales) in Australia (project identifier: 2020/ETH02540). All participants are required to provide written consent after being informed about the trial and the process evaluation. The results of this process evaluation will be published in peer-reviewed journals.Trial registration number Australian New Zealand Clinical Trial Registry (ACTRN12621000091808); Universal Trial Number (U1111-1264-1689).
