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The effect of side-alternating vibration therapy on mobility and health outcomes in young children with mild to moderate cerebral palsy: design and rationale for the randomized controlled study

BACKGROUND: Cerebral palsy (CP) is the most common cause of physical disability in early childhood. Vibration therapy (VT) is a promising rehabilitation approach for children with CP with potential to impact mobility, bone and muscle health as demonstrated by extant research. However, it is still un...

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Autores principales: Adaikina, Alena, Hofman, Paul L., Gusso, Silmara
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7643348/
https://www.ncbi.nlm.nih.gov/pubmed/33153439
http://dx.doi.org/10.1186/s12887-020-02377-2
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author Adaikina, Alena
Hofman, Paul L.
Gusso, Silmara
author_facet Adaikina, Alena
Hofman, Paul L.
Gusso, Silmara
author_sort Adaikina, Alena
collection PubMed
description BACKGROUND: Cerebral palsy (CP) is the most common cause of physical disability in early childhood. Vibration therapy (VT) is a promising rehabilitation approach for children with CP with potential to impact mobility, bone and muscle health as demonstrated by extant research. However, it is still unclear how long therapy must be conducted for and what the optimal vibration frequency is in order to gain health benefits. METHODS/DESIGN: The study is a randomized clinical trial evaluating and comparing the effects of two vibration frequency (20 Hz vs 25 Hz) and duration protocols (12 weeks vs 20 weeks) of side-alternating VT on mobility and other health parameters in children with CP. Children aged 5–12 years old with CP and GMFCS level I-III who are able to understand instruction and safely stand are eligible for the study. Exclusion criteria include bone fracture within 12 weeks of enrolment; acute conditions; the history of significant organic disease; the history of taking anabolic agents, glucocorticoids, growth hormone, and botulinum toxin injection into lower limbs within 3 months of enrolment. All participants will act as their own control with a 12-week lead-in period prior to intervention. The intervention period will consist of 20 weeks of home- or school-based VT 9 min per day, 4 times a week. After the baseline assessment, participants will be randomized to either a 20 Hz or 25 Hz vibration-frequency group. The primary outcome is mobility measured by a 6-min walking test, with analysis performed on the principle of intention to treat. Secondary outcomes include body composition, muscle strength, physical activity level, balance, gross motor function, respiratory function, and quality of life. Participants will undergo four assessment visits over the study period: baseline, at weeks 12, 24, and 32. DISCUSSION: The results of the study will provide evidence-based insights into the health benefits of side-alternating VT as a therapeutic tool in young children with cerebral palsy. The investigation of different vibration training protocols will help define the optimal parameters of intervention protocols (duration, frequency) of side-alternating VT to maximize outcomes on the health of 5–12-year-old children with CP. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): 12618002026202 (Registration date 18/12/2018).
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spelling pubmed-76433482020-11-06 The effect of side-alternating vibration therapy on mobility and health outcomes in young children with mild to moderate cerebral palsy: design and rationale for the randomized controlled study Adaikina, Alena Hofman, Paul L. Gusso, Silmara BMC Pediatr Study Protocol BACKGROUND: Cerebral palsy (CP) is the most common cause of physical disability in early childhood. Vibration therapy (VT) is a promising rehabilitation approach for children with CP with potential to impact mobility, bone and muscle health as demonstrated by extant research. However, it is still unclear how long therapy must be conducted for and what the optimal vibration frequency is in order to gain health benefits. METHODS/DESIGN: The study is a randomized clinical trial evaluating and comparing the effects of two vibration frequency (20 Hz vs 25 Hz) and duration protocols (12 weeks vs 20 weeks) of side-alternating VT on mobility and other health parameters in children with CP. Children aged 5–12 years old with CP and GMFCS level I-III who are able to understand instruction and safely stand are eligible for the study. Exclusion criteria include bone fracture within 12 weeks of enrolment; acute conditions; the history of significant organic disease; the history of taking anabolic agents, glucocorticoids, growth hormone, and botulinum toxin injection into lower limbs within 3 months of enrolment. All participants will act as their own control with a 12-week lead-in period prior to intervention. The intervention period will consist of 20 weeks of home- or school-based VT 9 min per day, 4 times a week. After the baseline assessment, participants will be randomized to either a 20 Hz or 25 Hz vibration-frequency group. The primary outcome is mobility measured by a 6-min walking test, with analysis performed on the principle of intention to treat. Secondary outcomes include body composition, muscle strength, physical activity level, balance, gross motor function, respiratory function, and quality of life. Participants will undergo four assessment visits over the study period: baseline, at weeks 12, 24, and 32. DISCUSSION: The results of the study will provide evidence-based insights into the health benefits of side-alternating VT as a therapeutic tool in young children with cerebral palsy. The investigation of different vibration training protocols will help define the optimal parameters of intervention protocols (duration, frequency) of side-alternating VT to maximize outcomes on the health of 5–12-year-old children with CP. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): 12618002026202 (Registration date 18/12/2018). BioMed Central 2020-11-05 /pmc/articles/PMC7643348/ /pubmed/33153439 http://dx.doi.org/10.1186/s12887-020-02377-2 Text en © The Author(s) 2020 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/. The Creative Commons Public Domain Dedication waiver (http://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
Adaikina, Alena
Hofman, Paul L.
Gusso, Silmara
The effect of side-alternating vibration therapy on mobility and health outcomes in young children with mild to moderate cerebral palsy: design and rationale for the randomized controlled study
title The effect of side-alternating vibration therapy on mobility and health outcomes in young children with mild to moderate cerebral palsy: design and rationale for the randomized controlled study
title_full The effect of side-alternating vibration therapy on mobility and health outcomes in young children with mild to moderate cerebral palsy: design and rationale for the randomized controlled study
title_fullStr The effect of side-alternating vibration therapy on mobility and health outcomes in young children with mild to moderate cerebral palsy: design and rationale for the randomized controlled study
title_full_unstemmed The effect of side-alternating vibration therapy on mobility and health outcomes in young children with mild to moderate cerebral palsy: design and rationale for the randomized controlled study
title_short The effect of side-alternating vibration therapy on mobility and health outcomes in young children with mild to moderate cerebral palsy: design and rationale for the randomized controlled study
title_sort effect of side-alternating vibration therapy on mobility and health outcomes in young children with mild to moderate cerebral palsy: design and rationale for the randomized controlled study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7643348/
https://www.ncbi.nlm.nih.gov/pubmed/33153439
http://dx.doi.org/10.1186/s12887-020-02377-2
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