Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia

BackgroundLoss of upper extremity function after tetraplegia results in significant disability. Emerging evidence from pilot studies suggests that functional electrical stimulation (FES) therapy may enhance recovery of upper extremity function after tetraplegia. The aim of this trial was to determin...

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Main Authors: Kim D. Anderson (Author), Radha Korupolu (Author), Kristin E. Musselman (Author), Jacqueline Pierce (Author), James R. Wilson (Author), Nuray Yozbatiran (Author), Naaz Desai (Author), Milos R. Popovic (Author), Lehana Thabane (Author)
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Published: Frontiers Media S.A., 2022-09-01T00:00:00Z.
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042 |a dc 
100 1 0 |a Kim D. Anderson  |e author 
700 1 0 |a Kim D. Anderson  |e author 
700 1 0 |a Radha Korupolu  |e author 
700 1 0 |a Radha Korupolu  |e author 
700 1 0 |a Kristin E. Musselman  |e author 
700 1 0 |a Kristin E. Musselman  |e author 
700 1 0 |a Jacqueline Pierce  |e author 
700 1 0 |a James R. Wilson  |e author 
700 1 0 |a James R. Wilson  |e author 
700 1 0 |a Nuray Yozbatiran  |e author 
700 1 0 |a Nuray Yozbatiran  |e author 
700 1 0 |a Naaz Desai  |e author 
700 1 0 |a Milos R. Popovic  |e author 
700 1 0 |a Milos R. Popovic  |e author 
700 1 0 |a Milos R. Popovic  |e author 
700 1 0 |a Lehana Thabane  |e author 
700 1 0 |a Lehana Thabane  |e author 
700 1 0 |a Lehana Thabane  |e author 
245 0 0 |a Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia 
260 |b Frontiers Media S.A.,   |c 2022-09-01T00:00:00Z. 
500 |a 2673-6861 
500 |a 10.3389/fresc.2022.995244 
520 |a BackgroundLoss of upper extremity function after tetraplegia results in significant disability. Emerging evidence from pilot studies suggests that functional electrical stimulation (FES) therapy may enhance recovery of upper extremity function after tetraplegia. The aim of this trial was to determine the effectiveness of FES therapy delivered by the Myndmove stimulator in people with tetraplegia.MethodsA multi-center, single-blind, parallel-group, two-arm, randomized controlled trial was conducted comparing FES to conventional therapy in adults (≥18 years) with C4-C7 traumatic incomplete tetraplegia between 4 and 96 months post-injury, and with a baseline spinal cord injury independence measure III -self-care (SCIM III-SC) score of ≤10. Participants were enrolled at four SCI-specialized neurorehabilitation centers in the U.S. and Canada. Participants were stratified by center and randomized in a 1:1 ratio to receive either 40 sessions of FES or conventional therapy targeting upper extremities over a 14-week period. Blinded assessors measured SCIM III, Toronto Rehabilitation Institute Hand Function Test, and Graded Redefined Assessment of Strength, Sensibility, and Prehension at baseline, after 20th session, after 40th session or 14 weeks after 1st session, and at 24 weeks after 1st session. The primary outcome measure was change in SCIM III-SC from baseline to end of the treatment. Based on the primary outcome measure, a sample size of 60 was calculated. Seventeen participants' progress in the study was interrupted due to the COVID-19 lockdown. The protocol was modified for these participants to allow them to complete the study.ResultsBetween June 2019 to August 2021, 51 participants were randomized to FES (n = 27) and conventional therapy (n = 24). Both groups gained a mean of 2 points in SCIM-SC scores at the end of treatment, which was a clinically meaningful change. However, there was no statistically significant difference between the groups on any outcomes.ConclusionForty sessions of FES therapy delivered by the MyndMove stimulator are as effective as conventional therapy in producing meaningful functional improvements that persist after therapy is completed. Limitations of this study include the impact of COVID-19 limiting the ability to recruit the target sample size and per-protocol execution of the study in one-third of the participants.RegistrationThis trial is registered at www.ClinicalTrials.gov, NCT03439319. 
546 |a EN 
690 |a functional electrical simulation (FES) 
690 |a spinal cord injury 
690 |a tetraplegia 
690 |a therapy 
690 |a rehabilation 
690 |a Other systems of medicine 
690 |a RZ201-999 
690 |a Medical technology 
690 |a R855-855.5 
655 7 |a article  |2 local 
786 0 |n Frontiers in Rehabilitation Sciences, Vol 3 (2022) 
787 0 |n https://www.frontiersin.org/articles/10.3389/fresc.2022.995244/full 
787 0 |n https://doaj.org/toc/2673-6861 
856 4 1 |u https://doaj.org/article/8dee12c38afa4c8d9cb8f33d7ece2376  |z Connect to this object online.