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...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-09-01
|
| Series: | Frontiers in Rehabilitation Sciences |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fresc.2022.995244/full |
| _version_ | 1797964759270686720 |
|---|---|
| author | Kim D. Anderson Kim D. Anderson Radha Korupolu Radha Korupolu Kristin E. Musselman Kristin E. Musselman Jacqueline Pierce James R. Wilson James R. Wilson Nuray Yozbatiran Nuray Yozbatiran Naaz Desai Milos R. Popovic Milos R. Popovic Milos R. Popovic Lehana Thabane Lehana Thabane Lehana Thabane |
| author_facet | Kim D. Anderson Kim D. Anderson Radha Korupolu Radha Korupolu Kristin E. Musselman Kristin E. Musselman Jacqueline Pierce James R. Wilson James R. Wilson Nuray Yozbatiran Nuray Yozbatiran Naaz Desai Milos R. Popovic Milos R. Popovic Milos R. Popovic Lehana Thabane Lehana Thabane Lehana Thabane |
| author_sort | Kim D. Anderson |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T01:48:58Z |
| format | Article |
| id | doaj.art-8dee12c38afa4c8d9cb8f33d7ece2376 |
| institution | Directory Open Access Journal |
| issn | 2673-6861 |
| language | English |
| last_indexed | 2024-04-11T01:48:58Z |
| publishDate | 2022-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Rehabilitation Sciences |
| spelling | doaj.art-8dee12c38afa4c8d9cb8f33d7ece23762023-01-03T07:14:12ZengFrontiers Media S.A.Frontiers in Rehabilitation Sciences2673-68612022-09-01310.3389/fresc.2022.995244995244Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegiaKim D. Anderson0Kim D. Anderson1Radha Korupolu2Radha Korupolu3Kristin E. Musselman4Kristin E. Musselman5Jacqueline Pierce6James R. Wilson7James R. Wilson8Nuray Yozbatiran9Nuray Yozbatiran10Naaz Desai11Milos R. Popovic12Milos R. Popovic13Milos R. Popovic14Lehana Thabane15Lehana Thabane16Lehana Thabane17MetroHealth Rehabilitation Institute, MetroHealth System, Cleveland, OH, United StatesDepartment of Physical Medicine and Rehabilitation, Case Western Reserve University School of Medicine, Cleveland, OH, United StatesDepartment of Physical Medicine and Rehabilitation, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, United StatesThe Institute of Rehabilitation / Research (TIRR) Memorial Hermann, Houston, TX, United StatesThe KITE Research Institute, University Health Network, Toronto, ON, CanadaDepartment of Physical Therapy, University of Toronto, Toronto, ON, CanadaHealthTech Connex Centre for Neurology Studies/Neuromotion Physiotherapy, Vancouver, BC, CanadaMetroHealth Rehabilitation Institute, MetroHealth System, Cleveland, OH, United StatesDepartment of Physical Medicine and Rehabilitation, Case Western Reserve University School of Medicine, Cleveland, OH, United StatesDepartment of Physical Medicine and Rehabilitation, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, United StatesThe Institute of Rehabilitation / Research (TIRR) Memorial Hermann, Houston, TX, United StatesKrembil Research Institute-University Health Network, Toronto, ON, CanadaThe KITE Research Institute, University Health Network, Toronto, ON, CanadaInstitute of Biomedical Engineering, University of Toronto, Toronto, ON, Canada0CRANIA, University Health Network, Toronto, ON, Canada1Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton ON, Canada2Biostatistics Unit, St. Joseph’s Healthcare, Hamilton, ON, Canada3Faculty of Health Sciences, University of Johannesburg, Johannesburg, Gauteng, South AfricaBackgroundLoss 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.https://www.frontiersin.org/articles/10.3389/fresc.2022.995244/fullfunctional electrical simulation (FES)spinal cord injurytetraplegiatherapyrehabilation |
| spellingShingle | Kim D. Anderson Kim D. Anderson Radha Korupolu Radha Korupolu Kristin E. Musselman Kristin E. Musselman Jacqueline Pierce James R. Wilson James R. Wilson Nuray Yozbatiran Nuray Yozbatiran Naaz Desai Milos R. Popovic Milos R. Popovic Milos R. Popovic Lehana Thabane Lehana Thabane Lehana Thabane Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia Frontiers in Rehabilitation Sciences functional electrical simulation (FES) spinal cord injury tetraplegia therapy rehabilation |
| title | Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia |
| title_full | Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia |
| title_fullStr | Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia |
| title_full_unstemmed | Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia |
| title_short | Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia |
| title_sort | multi center single blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia |
| topic | functional electrical simulation (FES) spinal cord injury tetraplegia therapy rehabilation |
| url | https://www.frontiersin.org/articles/10.3389/fresc.2022.995244/full |
| work_keys_str_mv | AT kimdanderson multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT kimdanderson multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT radhakorupolu multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT radhakorupolu multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT kristinemusselman multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT kristinemusselman multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT jacquelinepierce multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT jamesrwilson multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT jamesrwilson multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT nurayyozbatiran multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT nurayyozbatiran multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT naazdesai multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT milosrpopovic multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT milosrpopovic multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT milosrpopovic multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT lehanathabane multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT lehanathabane multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia AT lehanathabane multicentersingleblindrandomizedcontrolledtrialcomparingfunctionalelectricalstimulationtherapytoconventionaltherapyinincompletetetraplegia |