Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project)
Introduction Treadmill training and virtual reality have been investigated in children with cerebral palsy. However, few studies have assessed the effectiveness of the combination of both treatments on children’s functional and balance activities. The project aims to compare the effects of treadmill...
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BMJ Publishing Group
2022-11-01
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Series: | BMJ Open |
Online Access: | https://bmjopen.bmj.com/content/12/11/e061988.full |
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author | Mirari Ochandorena-Acha Marc Terradas-Monllor Tania Fabiola Nunes Cabrera Meritxell Torrabias Rodas Sergi Grau |
author_facet | Mirari Ochandorena-Acha Marc Terradas-Monllor Tania Fabiola Nunes Cabrera Meritxell Torrabias Rodas Sergi Grau |
author_sort | Mirari Ochandorena-Acha |
collection | DOAJ |
description | Introduction Treadmill training and virtual reality have been investigated in children with cerebral palsy. However, few studies have assessed the effectiveness of the combination of both treatments on children’s functional and balance activities. The project aims to compare the effects of treadmill training with and without virtual reality on walking endurance and speed, static and dynamic balance, gross motor function, functional independence, quality of life and occupational participation in children with spastic cerebral palsy between the ages of 4 and 12 years classified at levels I, II and III of the Gross Motor Function Classification System.Methods and analysis This study is a single-blind, two-arm parallel group, randomised, controlled clinical trial. Participants will be recruited at the Pediatric Department of the Vic Hospital Consortium, and the research will be conducted at the University of Vic – Central University of Catalonia. The participants will be randomly allocated into two groups: (1) the experimental group, which will receive the treadmill training at the same time as the virtual reality; and (2) the control group, which will undertake treadmill gait training alone. The training will be provided in 10 sessions over 2 weeks with 30 min for each session. Assessments will be performed on three occasions: 1 week before the intervention, 1 week following the intervention and 1 month after the end of the intervention. The evaluations will involve the 6 min walk test, stabilometry, the Berg Balance Scale, the 10 m walk test, the Gross Motor Function Measure, the Functional Independence Measure, the paediatric quality of life inventory and the Children Participation Questionnaire. For between-within group comparison, a mixed-effect linear model will be used.Ethics and dissemination The study has been approved by the Clinical Research Ethics Committee of the Osona Foundation for Health Research and Education (2021061). Results will be published in peer-reviewed journals and presented at international conferences.Trial registration number NCT05131724. |
first_indexed | 2024-04-11T07:08:06Z |
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issn | 2044-6055 |
language | English |
last_indexed | 2024-04-11T07:08:06Z |
publishDate | 2022-11-01 |
publisher | BMJ Publishing Group |
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series | BMJ Open |
spelling | doaj.art-a772cf8dcd464751991ba63ed9aaac612022-12-22T04:38:20ZengBMJ Publishing GroupBMJ Open2044-60552022-11-01121110.1136/bmjopen-2022-061988Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project)Mirari Ochandorena-Acha0Marc Terradas-Monllor1Tania Fabiola Nunes Cabrera2Meritxell Torrabias Rodas3Sergi Grau4Research group on Methodology, Methods, Models and Outcomes of Health and Social Sciences (M3O). Faculty of Health Sciences and Welfare. Centre for Health and Social Care Research (CESS). University of Vic-Central University of Catalonia (UVic-UCC), C.Sagrada Família, 7, 08500 Vic, SpainResearch group on Methodology, Methods, Models and Outcomes of Health and Social Sciences (M3O). Faculty of Health Sciences and Welfare. Centre for Health and Social Care Research (CESS). University of Vic-Central University of Catalonia (UVic-UCC), C.Sagrada Família, 7, 08500 Vic, SpainNeurology department, Sant Joan de Deu Barcelona Children`s Hospital, Barcelona, Catalonia, SpainPediatric Department, Consorci Hospitalari de Vic, Vic, Catalunya, SpainFaculty of Science and Technology, University of Vic - Central University of Catalonia, Vic, SpainIntroduction Treadmill training and virtual reality have been investigated in children with cerebral palsy. However, few studies have assessed the effectiveness of the combination of both treatments on children’s functional and balance activities. The project aims to compare the effects of treadmill training with and without virtual reality on walking endurance and speed, static and dynamic balance, gross motor function, functional independence, quality of life and occupational participation in children with spastic cerebral palsy between the ages of 4 and 12 years classified at levels I, II and III of the Gross Motor Function Classification System.Methods and analysis This study is a single-blind, two-arm parallel group, randomised, controlled clinical trial. Participants will be recruited at the Pediatric Department of the Vic Hospital Consortium, and the research will be conducted at the University of Vic – Central University of Catalonia. The participants will be randomly allocated into two groups: (1) the experimental group, which will receive the treadmill training at the same time as the virtual reality; and (2) the control group, which will undertake treadmill gait training alone. The training will be provided in 10 sessions over 2 weeks with 30 min for each session. Assessments will be performed on three occasions: 1 week before the intervention, 1 week following the intervention and 1 month after the end of the intervention. The evaluations will involve the 6 min walk test, stabilometry, the Berg Balance Scale, the 10 m walk test, the Gross Motor Function Measure, the Functional Independence Measure, the paediatric quality of life inventory and the Children Participation Questionnaire. For between-within group comparison, a mixed-effect linear model will be used.Ethics and dissemination The study has been approved by the Clinical Research Ethics Committee of the Osona Foundation for Health Research and Education (2021061). Results will be published in peer-reviewed journals and presented at international conferences.Trial registration number NCT05131724.https://bmjopen.bmj.com/content/12/11/e061988.full |
spellingShingle | Mirari Ochandorena-Acha Marc Terradas-Monllor Tania Fabiola Nunes Cabrera Meritxell Torrabias Rodas Sergi Grau Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project) BMJ Open |
title | Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project) |
title_full | Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project) |
title_fullStr | Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project) |
title_full_unstemmed | Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project) |
title_short | Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project) |
title_sort | effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy a single blind two arm parallel group randomised clinical trial virtwalkcp project |
url | https://bmjopen.bmj.com/content/12/11/e061988.full |
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