Safety and efficacy of intensive task-specific training in people with recent spinal cord injury: a phase 3, pragmatic, randomised, assessor-blinded, superiority trial
作者:Joanne V. Glinsky, Jackie Chu, Christine Rimmer, Sharon Roberts, Giorgio Scivoletto, Federica Tamburella, Claire Lincoln, Marsha Ben, Qiang Li, Robert D Herbert, Fernanda Di Natal, Lydia W. Chen, Donna Rainey, Vivien Jørgensen, J Stolwijk, Jessica van der Lede, Charlotte C. M. van Laake-Geelen, Mark McDonald, Emilie Gollan, Sue Paddison, Chris Bell, Kristine Oostra, Lot Van Roey, Jayanthi Mysore, Annemie Spooren, Keira E Tranter, Hueiming Liu, Stephen Jan, Daniel Treacy, Ian D. Cameron, Gerard Weber, Catherine Sherrington, Euan J. McCaughey, Emma-Leigh Synnott, Jasbeer Kaur, Sachin Shetty, Lisa A Harvey · 发表于:The Lancet Neurology · 年份:2026 · DOI:10.1016/s1474-4422(26)00010-4 · 被引用次数:4 · 研究领域:Spinal Cord Injury Research、Traumatic Brain Injury Research、Stroke Rehabilitation and Recovery
BACKGROUND: It is widely believed that intensive task-specific training enhances neurological recovery in people with spinal cord injury (SCI) by exploiting activity-dependent spinal plasticity. We aimed to determine whether 10 weeks of intensive task-specific training supplemented with strength training that targets motor function at and below the level of the lesion improves recovery following recent SCI. METHODS: We conducted a pragmatic phase 3 superiority randomised controlled trial at 15 hospitals in Australia, Belgium, Italy, the Netherlands, Norway, and the UK (England and Scotland). People who sustained a SCI in the preceding 10 weeks, had some motor function below the level of injury, and were receiving inpatient rehabilitation were randomly assigned to usual care (control group) or usual care plus 12 h per week for 10 weeks of intensive task-specific training targeting voluntary motor function below the level of the lesion supplemented with strength training (intervention group). Randomisation was computer generated, concealed, and stratified by site and level of injury. The primary outcome was Total Motor Score of the International Standards for the Neurological Classification of SCI (0-100 points) at 10 weeks. The outcome assessors were blinded to group assignment. Serious adverse events were defined as those resulting in death, life-threatening conditions, prolongation of hospitalisation, or substantial disability. All analyses were conducted by intention to tre...