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A randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the FES on participation (FESPa) trial
BACKGROUND: Spastic cerebral palsy is the most common cause of motor disability in children. It often leads to foot drop or equinus, interfering with walking. Ankle-foot orthoses (AFOs) are commonly used in these cases. However, AFOs can be too restrictive for mildly impaired patients. Functional el...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8756646/ https://www.ncbi.nlm.nih.gov/pubmed/35027013 http://dx.doi.org/10.1186/s12887-021-03037-9 |
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author | Moll, Irene Marcellis, Rik G. J. Coenen, Marcel L. P. Fleuren, Sabine M. Willems, Paul J. B. Speth, Lucianne A. W. M. Witlox, M. Adhiambo Meijer, Kenneth Vermeulen, R. Jeroen |
author_facet | Moll, Irene Marcellis, Rik G. J. Coenen, Marcel L. P. Fleuren, Sabine M. Willems, Paul J. B. Speth, Lucianne A. W. M. Witlox, M. Adhiambo Meijer, Kenneth Vermeulen, R. Jeroen |
author_sort | Moll, Irene |
collection | PubMed |
description | BACKGROUND: Spastic cerebral palsy is the most common cause of motor disability in children. It often leads to foot drop or equinus, interfering with walking. Ankle-foot orthoses (AFOs) are commonly used in these cases. However, AFOs can be too restrictive for mildly impaired patients. Functional electrical stimulation (FES) of the ankle-dorsiflexors is an alternative treatment as it could function as a dynamic functional orthosis. Despite previous research, high level evidence on the effects of FES on activities and participation in daily life is missing. The primary aim of this study is to evaluate whether FES improves the activity and participation level in daily life according to patients, and the secondary aim is to provide evidence of the effect of FES at the level of body functions and activities. Furthermore, we aim to collect relevant information for decisions on its clinical implementation. METHODS: A randomized crossover trial will be performed on 25 children with unilateral spastic cerebral palsy. Patients aged between 4 and 18 years, with Gross Motor Functioning Classification System level I or II and unilateral foot drop of central origin, currently treated with AFO or adapted shoes, will be included. All participants will undergo twelve weeks of conventional treatment (AFO/adapted shoes) and 12 weeks of FES treatment, separated by a six-week washout-phase. FES treatment consists of wearing the WalkAide® device, with surface electrodes stimulating the peroneal nerve during swing phase of gait. For the primary objective, the Goal Attainment Scale is used to test whether FES improves activities and participation in daily life. The secondary objective is to prove whether FES is effective at the level of body functions and structures, and activities, including ankle kinematics and kinetics measured during 3D-gait analysis and questionnaire-based frequency of falling. The tertiary objective is to collect relevant information for clinical implementation, including acceptability using the device log file and side effect registration, cost-effectiveness based on quality adjusted life years (QALYs) and clinical characteristics for patient selection. DISCUSSION: We anticipate that the results of this study will allow evidence-based use of FES during walking in children with unilateral spastic cerebral palsy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03440632. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12887-021-03037-9. |
format | Online Article Text |
id | pubmed-8756646 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-87566462022-01-18 A randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the FES on participation (FESPa) trial Moll, Irene Marcellis, Rik G. J. Coenen, Marcel L. P. Fleuren, Sabine M. Willems, Paul J. B. Speth, Lucianne A. W. M. Witlox, M. Adhiambo Meijer, Kenneth Vermeulen, R. Jeroen BMC Pediatr Study Protocol BACKGROUND: Spastic cerebral palsy is the most common cause of motor disability in children. It often leads to foot drop or equinus, interfering with walking. Ankle-foot orthoses (AFOs) are commonly used in these cases. However, AFOs can be too restrictive for mildly impaired patients. Functional electrical stimulation (FES) of the ankle-dorsiflexors is an alternative treatment as it could function as a dynamic functional orthosis. Despite previous research, high level evidence on the effects of FES on activities and participation in daily life is missing. The primary aim of this study is to evaluate whether FES improves the activity and participation level in daily life according to patients, and the secondary aim is to provide evidence of the effect of FES at the level of body functions and activities. Furthermore, we aim to collect relevant information for decisions on its clinical implementation. METHODS: A randomized crossover trial will be performed on 25 children with unilateral spastic cerebral palsy. Patients aged between 4 and 18 years, with Gross Motor Functioning Classification System level I or II and unilateral foot drop of central origin, currently treated with AFO or adapted shoes, will be included. All participants will undergo twelve weeks of conventional treatment (AFO/adapted shoes) and 12 weeks of FES treatment, separated by a six-week washout-phase. FES treatment consists of wearing the WalkAide® device, with surface electrodes stimulating the peroneal nerve during swing phase of gait. For the primary objective, the Goal Attainment Scale is used to test whether FES improves activities and participation in daily life. The secondary objective is to prove whether FES is effective at the level of body functions and structures, and activities, including ankle kinematics and kinetics measured during 3D-gait analysis and questionnaire-based frequency of falling. The tertiary objective is to collect relevant information for clinical implementation, including acceptability using the device log file and side effect registration, cost-effectiveness based on quality adjusted life years (QALYs) and clinical characteristics for patient selection. DISCUSSION: We anticipate that the results of this study will allow evidence-based use of FES during walking in children with unilateral spastic cerebral palsy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03440632. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12887-021-03037-9. BioMed Central 2022-01-13 /pmc/articles/PMC8756646/ /pubmed/35027013 http://dx.doi.org/10.1186/s12887-021-03037-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Moll, Irene Marcellis, Rik G. J. Coenen, Marcel L. P. Fleuren, Sabine M. Willems, Paul J. B. Speth, Lucianne A. W. M. Witlox, M. Adhiambo Meijer, Kenneth Vermeulen, R. Jeroen A randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the FES on participation (FESPa) trial |
title | A randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the FES on participation (FESPa) trial |
title_full | A randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the FES on participation (FESPa) trial |
title_fullStr | A randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the FES on participation (FESPa) trial |
title_full_unstemmed | A randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the FES on participation (FESPa) trial |
title_short | A randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the FES on participation (FESPa) trial |
title_sort | randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the fes on participation (fespa) trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8756646/ https://www.ncbi.nlm.nih.gov/pubmed/35027013 http://dx.doi.org/10.1186/s12887-021-03037-9 |
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