TY - JOUR
T1 - Transcutaneous spinal cord stimulation combined with locomotor training to improve walking ability in people with chronic spinal cord injury
T2 - study protocol for an international multi-centred double-blinded randomised sham-controlled trial (eWALK)
AU - Bye, Elizabeth A.
AU - Héroux, Martin E.
AU - Boswell-Ruys, Claire L.
AU - Perez, Monica A.
AU - Purcell, Mariel
AU - Taylor, Julian
AU - Lee, Bonsan B.
AU - McCaughey, Euan J.
AU - Butler, Jane E.
AU - Gandevia, Simon C.
N1 - Funding Information:
Funding for this study has been received from SpinalCure Australia and Catwalk NZ.
Publisher Copyright:
© 2021, The Author(s), under exclusive licence to International Spinal Cord Society.
PY - 2022/6
Y1 - 2022/6
N2 - Study design: An international multi-centred, double-blinded, randomised sham-controlled trial (eWALK). Objective: To determine the effect of 12 weeks of transcutaneous spinal stimulation (TSS) combined with locomotor training on walking ability in people with spinal cord injury (SCI). Setting: Dedicated SCI research centres in Australia, Spain, USA and Scotland. Methods: Fifty community-dwelling individuals with chronic SCI will be recruited. Participants will be eligible if they have bilateral motor levels between T1 and T11, a reproducible lower limb muscle contraction in at least one muscle group, and a Walking Index for SCI II (WISCI II) between 1 and 6. Eligible participants will be randomised to one of two groups, either the active stimulation group or the sham stimulation group. Participants allocated to the stimulation group will receive TSS combined with locomotor training for three 30-min sessions a week for 12 weeks. The locomotor sessions will include walking on a treadmill and overground. Participants allocated to the sham stimulation group will receive the same locomotor training combined with sham stimulation. The primary outcome will be walking ability with stimulation using the WISCI II. Secondary outcomes will record sensation, strength, spasticity, bowel function and quality of life. Trial registration: ANZCTR.org.au
AB - Study design: An international multi-centred, double-blinded, randomised sham-controlled trial (eWALK). Objective: To determine the effect of 12 weeks of transcutaneous spinal stimulation (TSS) combined with locomotor training on walking ability in people with spinal cord injury (SCI). Setting: Dedicated SCI research centres in Australia, Spain, USA and Scotland. Methods: Fifty community-dwelling individuals with chronic SCI will be recruited. Participants will be eligible if they have bilateral motor levels between T1 and T11, a reproducible lower limb muscle contraction in at least one muscle group, and a Walking Index for SCI II (WISCI II) between 1 and 6. Eligible participants will be randomised to one of two groups, either the active stimulation group or the sham stimulation group. Participants allocated to the stimulation group will receive TSS combined with locomotor training for three 30-min sessions a week for 12 weeks. The locomotor sessions will include walking on a treadmill and overground. Participants allocated to the sham stimulation group will receive the same locomotor training combined with sham stimulation. The primary outcome will be walking ability with stimulation using the WISCI II. Secondary outcomes will record sensation, strength, spasticity, bowel function and quality of life. Trial registration: ANZCTR.org.au
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U2 - 10.1038/s41393-021-00734-1
DO - 10.1038/s41393-021-00734-1
M3 - Article
C2 - 35013547
AN - SCOPUS:85122691294
SN - 1362-4393
VL - 60
SP - 491
EP - 497
JO - Spinal Cord
JF - Spinal Cord
IS - 6
ER -