Early and intensive motor training to enhance neurological recovery in people with spinal cord injury: trial protocol
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Published:2023-07-06
Issue:9
Volume:61
Page:521-527
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ISSN:1362-4393
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Container-title:Spinal Cord
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language:en
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Short-container-title:Spinal Cord
Author:
Harvey Lisa A.ORCID, Glinsky Joanne V., Chu JackieORCID, Herbert Robert D., Liu HueimingORCID, Jan Stephen, Billot LaurentORCID, Scivoletto GiorgioORCID, Spooren Annemie I., Seelen Henk A., Ben Marsha, Tranter Keira, Chen Lydia W., Rainey Donna, Rimmer Christine, Jorgensen VivienORCID, Di Natal Fernanda, Denis Sophie, Gollan Emilie J., Tamburella FedericaORCID, Agostinello Jacqui, van Laake-Geelen Charlotte M., Bell Chris, Lincoln Claire, Stolwijk Janneke M.ORCID, van der Lede Jessica, Paddison Sue, Oostra Kristine, Cameron Ian D., Weber Gerard, Sherrington Catherine, Nunn Andrew K., Synnott Emma-Leigh, McCaughey EuanORCID, Kaur Jasbeer, Shetty Sachin
Abstract
Abstract
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).
Funder
NSW Ministry of Health, Australia; and Wings for Life Foundation, Austria.
Publisher
Springer Science and Business Media LLC
Subject
Neurology (clinical),Neurology,General Medicine
Reference59 articles.
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