TY - JOUR
T1 - Early and intensive motor training to enhance neurological recovery in people with spinal cord injury
T2 - trial protocol
AU - Harvey, Lisa A.
AU - Glinsky, Joanne V.
AU - Chu, Jackie
AU - Herbert, Robert D.
AU - Liu, Hueiming
AU - Jan, Stephen
AU - Billot, Laurent
AU - Scivoletto, Giorgio
AU - Spooren, Annemie I.
AU - Seelen, Henk A.
AU - Ben, Marsha
AU - Tranter, Keira
AU - Chen, Lydia W.
AU - Rainey, Donna
AU - Rimmer, Christine
AU - Jorgensen, Vivien
AU - Di Natal, Fernanda
AU - Denis, Sophie
AU - Gollan, Emilie J.
AU - Tamburella, Federica
AU - Agostinello, Jacqui
AU - van Laake-Geelen, Charlotte M.
AU - Bell, Chris
AU - Lincoln, Claire
AU - Stolwijk, Janneke M.
AU - van der Lede, Jessica
AU - Paddison, Sue
AU - Oostra, Kristine
AU - Cameron, Ian D.
AU - Weber, Gerard
AU - Sherrington, Catherine
AU - Nunn, Andrew K.
AU - Synnott, Emma Leigh
AU - McCaughey, Euan
AU - Kaur, Jasbeer
AU - Shetty, Sachin
N1 - Copyright the Author(s) 2023. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.
PY - 2023/9
Y1 - 2023/9
N2 - Study design: Protocol for a multi-centre randomised controlled trial (the SCI-MT trial). Objectives: To determine whether 10 weeks of intensive motor training enhances neurological recovery in people with recent spinal cord injury (SCI). Setting: Fifteen spinal injury units in Australia, Scotland, England, Italy, Netherlands, Norway, and Belgium. Methods: A pragmatic randomised controlled trial will be undertaken. Two hundred and twenty people with recent SCI (onset in the preceding 10 weeks, American Spinal Injuries Association Impairment Scale (AIS) A lesion with motor function more than three levels below the motor level on one or both sides, or an AIS C or D lesion) will be randomised to receive either usual care plus intensive motor training (12 h of motor training per week for 10 weeks) or usual care alone. The primary outcome is neurological recovery at 10 weeks, measured with the Total Motor Score from the International Standards for Neurological Classification of SCI. Secondary outcomes include global measures of motor function, ability to walk, quality of life, participants’ perceptions about ability to perform self-selected goals, length of hospital stay and participants’ impressions of therapeutic benefit at 10 weeks and 6 months. A cost-effectiveness study and process evaluation will be run alongside the trial. The first participant was randomised in June 2021 and the trial is due for completion in 2025. Conclusions: The findings of the SCI-MT Trial will guide recommendations about the type and dose of inpatient therapy that optimises neurological recovery in people with SCI. Trial registration: ACTRN12621000091808 (1.2.2021).
AB - Study design: Protocol for a multi-centre randomised controlled trial (the SCI-MT trial). Objectives: To determine whether 10 weeks of intensive motor training enhances neurological recovery in people with recent spinal cord injury (SCI). Setting: Fifteen spinal injury units in Australia, Scotland, England, Italy, Netherlands, Norway, and Belgium. Methods: A pragmatic randomised controlled trial will be undertaken. Two hundred and twenty people with recent SCI (onset in the preceding 10 weeks, American Spinal Injuries Association Impairment Scale (AIS) A lesion with motor function more than three levels below the motor level on one or both sides, or an AIS C or D lesion) will be randomised to receive either usual care plus intensive motor training (12 h of motor training per week for 10 weeks) or usual care alone. The primary outcome is neurological recovery at 10 weeks, measured with the Total Motor Score from the International Standards for Neurological Classification of SCI. Secondary outcomes include global measures of motor function, ability to walk, quality of life, participants’ perceptions about ability to perform self-selected goals, length of hospital stay and participants’ impressions of therapeutic benefit at 10 weeks and 6 months. A cost-effectiveness study and process evaluation will be run alongside the trial. The first participant was randomised in June 2021 and the trial is due for completion in 2025. Conclusions: The findings of the SCI-MT Trial will guide recommendations about the type and dose of inpatient therapy that optimises neurological recovery in people with SCI. Trial registration: ACTRN12621000091808 (1.2.2021).
UR - http://www.scopus.com/inward/record.url?scp=85164125827&partnerID=8YFLogxK
U2 - 10.1038/s41393-023-00908-z
DO - 10.1038/s41393-023-00908-z
M3 - Article
C2 - 37414835
AN - SCOPUS:85164125827
SN - 1362-4393
VL - 61
SP - 521
EP - 527
JO - Spinal Cord
JF - Spinal Cord
IS - 9
ER -