Protocol for rapid onset of mobilisation in patients with traumatic spinal cord injury (PROMPT-SCI) study: a single-arm proof-of-concept trial of early in-bed leg cycling following acute traumatic spinal cord injury

Jean-Marc Mac-Thiong, Andreane Richard-Denis, Yvan Petit, Francis Bernard, Dorothy Barthélemy, Antoine Dionne, David S K Magnuson, Jean-Marc Mac-Thiong, Andreane Richard-Denis, Yvan Petit, Francis Bernard, Dorothy Barthélemy, Antoine Dionne, David S K Magnuson

Abstract

Introduction: Activity-based therapy (ABT) is an important aspect of rehabilitation following traumatic spinal cord injury (SCI). Unfortunately, it has never been adapted to acute care despite compelling preclinical evidence showing that it is safe and effective for promoting neurological recovery when started within days after SCI. This article provides the protocol for a study that will determine the feasibility and explore potential benefits of early ABT in the form of in-bed leg cycling initiated within 48 hours after the end of spinal surgery for SCI.

Methods and analysis: PROMPT-SCI (protocol for rapid onset of mobilisation in patients with traumatic SCI) is a single-site single-arm proof-of-concept trial. Forty-five patients aged 18 years or older with a severe traumatic SCI (American Spinal Injury Association Impairment Scale grade A, B or C) from C0 to L2 undergoing spinal surgery within 48 hours of the injury will be included. Participants will receive daily 30 min continuous sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours of the end of spinal surgery. The feasibility outcomes are: (1) absence of serious adverse events associated with cycling, (2) completion of 1 full session within 48 hours of spinal surgery for 90% of participants and (3) completion of 11 sessions for 80% of participants. Patient outcomes 6 weeks and 6 months after the injury will be measured using neurofunctional assessments, quality of life questionnaires and inpatient length of stay. Feasibility and patient outcomes will be analysed with descriptive statistics. Patient outcomes will also be compared with a matched historical cohort that has not undergone in-bed cycling using McNemar and Student's t-tests for binary and continuous outcomes, respectively.

Ethics and dissemination: PROMPT-SCI is approved by the Research Ethics Board of the CIUSSS NIM. Recruitment began in April 2021. Dissemination strategies include publications in scientific journals and presentations at conferences.

Trial registration number: NCT04699474.

Keywords: adult intensive & critical care; neurophysiology; rehabilitation medicine; spine; surgery; trauma management.

Conflict of interest statement

Competing interests: J-MM-T is chairholder of Medtronic research chair in spinal trauma at Université de Montréal, owns stocks and is a board member in Spinologics Inc. and subsidaries, has received a scholarship and research grants from the Fonds de recherche du Québec—Santé, an investigator-initiated research grant from Medline Industries, educational grants from Medtronic and Depuy-Synthes, as well as research grants from the US Department of Defence—Congressionally directed medical research programmes, Craig H. Neilsen Foundation, from Social Sciences and Humanities Research Council, Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, Canada foundation for innovation, Praxis Spinal Cord Institute, Fondation de recherche et d’Éducation en Orthopédie de Montréal, and has obtained research contracts from Vertex Pharmaceutical, AbbVie and Asahi KASEI Pharma Corporation. AR-D has received a scholarship and research grants from the Fonds de recherche du Québec—Santé, an investigator-initiated research grant from Medline Industries, as well as research grants from Praxis Spinal Cord Institute, Craig H. Neilsen Foundation, Social Sciences and Humanities Research Council, Canadian Institutes of Health Research, and Natural Sciences and Engineering Research Council. YP is chairholder of the Canada Research Chair in biomechanics of head and spine trauma at École de technologie supérieure. He is currently principal investigator or coinvestigator of research grants obtained from the Fonds de recherche du Québec—Nature et technologies (FRQNT), Fonds de recherche du Québec—Société et Culture (FRQSC), Canadian Social Sciences and Humanities Research Council, Natural Science and Engineering and Research Council (NSERC), PRIMA Québec Consortium, MedTeQ Consortium, CCM Hockey and Kollide Inc. He also currently has a research collaboration agreement (no funding associated) with Spinologics Inc. FB has no competing interests. DB received a New investigator award and research grant from the Fonds de recherche du Québec—Santé and research grants from Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council and Canada Foundation for Innovation. AD has no competing interests. DSKM is the Friends for Michael Chair of Neurosurgery at the University of Louisville. He has received grants from the Kentucky Spinal Cord and Head Injury Research Trust, the National Institutes of Health (NINDS), the Department of Defence—Congressionally Directed Medical Research Programmes, the Craig H. Neilsen Foundation, and from the Wings for Life Foundation. He is also part of the ReCon Team supported by the Ontario Neurotrauma Foundation.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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