The Early and Intensive Motor Training for Spinal Cord Injury Trial: key principles to consider when undertaking large international investigator-driven clinical trials
Year: 2026
Type: article
Abstract: STUDY DESIGN: Methodological commentary. OBJECTIVES: To summarise key methodological and operational principles for designing and conducting large, international, investigator-driven clinical trials involving physical interventions for people with recent spinal cord injuries (SCI). This paper draws on our experience designing and conducting The Early and Intensive Motor Training for SCI Trial (SCI-MT Trial). SETTING: 15 spinal injury units across Australia, Scotland, England, Italy, the Netherlands, Norway, and Belgium. METHODS: We reviewed the SCI-MT Trial protocol, documentation, and procedures to identify key methodological and operational issues relevant to large, international trials involving physical interventions for people with recent SCI. Guidance was developed based on both our practical experience and current recommendations from clinical trial experts, with the aim of informing and supporting future trialists. RESULTS: We identified key principles that should be considered when designing and conducting trials of physical interventions for people with recent SCI. These included principles related to trial design (Methodological Principles) and trial conduct (Operational Principles). CONCLUSIONS: This paper provides guidance on the principles and practicalities of designing and implementing large, international, investigator-driven clinical trials. It is intended to assist future trialists in planning trials that are methodologically rigorous, operationally feasible, and ethically robust. TRIAL REGISTRATION: ACTRN12621000091808 (1.2.2021). TRIAL IDENTIFIER NO: U1111-1264-1689. PROTOCOL NO: Version 1.3, 22nd Oct 2021.
Source: Spinal Cord
Authors: Lisa A. Harvey, Joanne V. Glinsky, Jackie Chu, Marsha Ben, Chris Bell, Lydia W. Chen, Sophia Denis, Fernanda Di Natal, Emilie J. Gollan, Vivien Jørgensen, Charlotte C. M. Van Laake-Geelen, Jessica van der Lede, Claire Lincoln, Mark McDonald, Kristine Oostra, Sue Paddison, Donna Rainey, Christine Rimmer, Sharon Roberts, Lot Van Roey, Giorgio Scivoletto, Annemie I. Spooren, Janneke M. Stolwijk, Federica Tamburella, Keira E. Tranter
Institutions: The University of Sydney, Northern Sydney Local Health District, Royal North Shore Hospital, Prince of Wales Hospital, Princess Alexandra Hospital, Sunnaas sykehus, Leiden University, Leiden University Medical Center, Maastricht University, Adelante, Care and Public Health Research Institute, Utrecht University, University Medical Center Utrecht, De Hoogstraat Revalidatie, Queen Elizabeth University Hospital, Austin Health, Ghent University Hospital, Royal National Orthopaedic Hospital, Royal National Orthopaedic Hospital NHS Trust, Royal Rehabilitation Centre, Fiona Stanley Hospital, CTO Andrea Alesini, Hasselt University, Fondazione Santa Lucia, Link Campus University
Language: English
Topic: Spinal Cord Injury Research
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,990
Funders: Wings for Life, NSW Ministry of Health
OpenAlex ID: W7166663592