Protocol for rapid onset of mobilisation in patients with traumatic spinal cordinjury (PROMPT-SCI) study: a single- arm proof-of-concept trial of early in- bed leg cycling following acute traumatic spinal cord injury
| Résumé | 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. |
| Auteurs | Jean-Marc Mac-Thiong, Andreane Richard-Denis, Yvan Petit, Francis Bernard, Dorothy Barthélemy, Antoine Dionne, David S K Magnuson |
| Titre de revue/journal, volume et numéro | British Medical Journal, volume 11, numéro 11. |
| Langue de la publication et/ou de traduction | Anglais (langue d’origine) |
| Année de parution | 2021 |
| Pays | Québec, Canada. |
| Institutions affiliées | Université de Montréal, Hôpital du Sacré-Cœur de Montréal, University of Louisville. |
| Lien vers la publication | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8562499/ |
| Type d’accès à la publication | Gratuit |
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