Motor Effects of Intervention With Transcranial Direct Current Stimulation for Physiotherapy Treatment in Children With Cerebral Palsy: Protocol for a Randomized Clinical Trial

Children diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily living. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has been used to improve movement, gross motor funct...

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Published in:JMIR research protocols Vol. 13; p. e52922
Main Authors: Cangussu, Anna Izabel, Lucarini, Beatriz, Melo, Igor de Freitas, Diniz, Paula Araújo, Mancini, Marisa, Viana, Bernardo de Mattos, Romano-Silva, Marco Aurélio, Miranda, Débora Marques de
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Abstract Children diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily living. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has been used to improve movement, gross motor function, and activities of daily living. This study aims to evaluate the potential additional effects of physiotherapy combined with tDCS in children with CP in comparison with physiotherapy only. This is a 2-arm randomized controlled trial that will compare the effects of tDCS as an adjunctive treatment during rehabilitation sessions to rehabilitation without tDCS. Children with CP classified by the Gross Motor Function Classification System as levels I and II will be randomly assigned to either the sham + rehabilitation group or the tDCS + rehabilitation group. The primary outcome will be the motor skills assessed using the Gross Motor Function Measure domain E scores, and the secondary outcome will be the measurement scores of the children's quality of life. The intervention will consist of a 10-day stimulation protocol with tDCS spread over 2 weeks, with stimulation or sham tDCS administered for 20 minutes at a frequency of 1 Hz, in combination with physiotherapy. Physical therapy exercises will be conducted in a circuit based on each child's baseline Gross Motor Function Measure results. The participants' changes will be evaluated and compared in both groups. Intervenient features will be tested. Data collection is ongoing and is expected to be completed by January 2025. A homogeneous sample and clear outcomes may be a highlight of this protocol, which may allow us to understand the potential use of tDCS and for whom it should or should not be used. A study with good evidence and clear outcomes in children with CP might open an avenue for the potential best use of neurostimulation. Brazilian Registry of Clinical Trials RBR-104h4s4y; https://tinyurl.com/47r3x2e4. PRR1-10.2196/52922.
AbstractList Children diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily living. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has been used to improve movement, gross motor function, and activities of daily living. This study aims to evaluate the potential additional effects of physiotherapy combined with tDCS in children with CP in comparison with physiotherapy only. This is a 2-arm randomized controlled trial that will compare the effects of tDCS as an adjunctive treatment during rehabilitation sessions to rehabilitation without tDCS. Children with CP classified by the Gross Motor Function Classification System as levels I and II will be randomly assigned to either the sham + rehabilitation group or the tDCS + rehabilitation group. The primary outcome will be the motor skills assessed using the Gross Motor Function Measure domain E scores, and the secondary outcome will be the measurement scores of the children's quality of life. The intervention will consist of a 10-day stimulation protocol with tDCS spread over 2 weeks, with stimulation or sham tDCS administered for 20 minutes at a frequency of 1 Hz, in combination with physiotherapy. Physical therapy exercises will be conducted in a circuit based on each child's baseline Gross Motor Function Measure results. The participants' changes will be evaluated and compared in both groups. Intervenient features will be tested. Data collection is ongoing and is expected to be completed by January 2025. A homogeneous sample and clear outcomes may be a highlight of this protocol, which may allow us to understand the potential use of tDCS and for whom it should or should not be used. A study with good evidence and clear outcomes in children with CP might open an avenue for the potential best use of neurostimulation. Brazilian Registry of Clinical Trials RBR-104h4s4y; https://tinyurl.com/47r3x2e4. PRR1-10.2196/52922.
BackgroundChildren diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily living. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has been used to improve movement, gross motor function, and activities of daily living. ObjectiveThis study aims to evaluate the potential additional effects of physiotherapy combined with tDCS in children with CP in comparison with physiotherapy only. MethodsThis is a 2-arm randomized controlled trial that will compare the effects of tDCS as an adjunctive treatment during rehabilitation sessions to rehabilitation without tDCS. Children with CP classified by the Gross Motor Function Classification System as levels I and II will be randomly assigned to either the sham + rehabilitation group or the tDCS + rehabilitation group. The primary outcome will be the motor skills assessed using the Gross Motor Function Measure domain E scores, and the secondary outcome will be the measurement scores of the children’s quality of life. The intervention will consist of a 10-day stimulation protocol with tDCS spread over 2 weeks, with stimulation or sham tDCS administered for 20 minutes at a frequency of 1 Hz, in combination with physiotherapy. Physical therapy exercises will be conducted in a circuit based on each child’s baseline Gross Motor Function Measure results. The participants’ changes will be evaluated and compared in both groups. Intervenient features will be tested. ResultsData collection is ongoing and is expected to be completed by January 2025. A homogeneous sample and clear outcomes may be a highlight of this protocol, which may allow us to understand the potential use of tDCS and for whom it should or should not be used. ConclusionsA study with good evidence and clear outcomes in children with CP might open an avenue for the potential best use of neurostimulation. Trial RegistrationBrazilian Registry of Clinical Trials RBR-104h4s4y; https://tinyurl.com/47r3x2e4 International Registered Report Identifier (IRRID)PRR1-10.2196/52922
BACKGROUNDChildren diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily living. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has been used to improve movement, gross motor function, and activities of daily living.OBJECTIVEThis study aims to evaluate the potential additional effects of physiotherapy combined with tDCS in children with CP in comparison with physiotherapy only.METHODSThis is a 2-arm randomized controlled trial that will compare the effects of tDCS as an adjunctive treatment during rehabilitation sessions to rehabilitation without tDCS. Children with CP classified by the Gross Motor Function Classification System as levels I and II will be randomly assigned to either the sham + rehabilitation group or the tDCS + rehabilitation group. The primary outcome will be the motor skills assessed using the Gross Motor Function Measure domain E scores, and the secondary outcome will be the measurement scores of the children's quality of life. The intervention will consist of a 10-day stimulation protocol with tDCS spread over 2 weeks, with stimulation or sham tDCS administered for 20 minutes at a frequency of 1 Hz, in combination with physiotherapy. Physical therapy exercises will be conducted in a circuit based on each child's baseline Gross Motor Function Measure results. The participants' changes will be evaluated and compared in both groups. Intervenient features will be tested.RESULTSData collection is ongoing and is expected to be completed by January 2025. A homogeneous sample and clear outcomes may be a highlight of this protocol, which may allow us to understand the potential use of tDCS and for whom it should or should not be used.CONCLUSIONSA study with good evidence and clear outcomes in children with CP might open an avenue for the potential best use of neurostimulation.TRIAL REGISTRATIONBrazilian Registry of Clinical Trials RBR-104h4s4y; https://tinyurl.com/47r3x2e4.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)PRR1-10.2196/52922.
Background:Children diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily living. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has been used to improve movement, gross motor function, and activities of daily living.Objective:This study aims to evaluate the potential additional effects of physiotherapy combined with tDCS in children with CP in comparison with physiotherapy only.Methods:This is a 2-arm randomized controlled trial that will compare the effects of tDCS as an adjunctive treatment during rehabilitation sessions to rehabilitation without tDCS. Children with CP classified by the Gross Motor Function Classification System as levels I and II will be randomly assigned to either the sham + rehabilitation group or the tDCS + rehabilitation group. The primary outcome will be the motor skills assessed using the Gross Motor Function Measure domain E scores, and the secondary outcome will be the measurement scores of the children’s quality of life. The intervention will consist of a 10-day stimulation protocol with tDCS spread over 2 weeks, with stimulation or sham tDCS administered for 20 minutes at a frequency of 1 Hz, in combination with physiotherapy. Physical therapy exercises will be conducted in a circuit based on each child’s baseline Gross Motor Function Measure results. The participants’ changes will be evaluated and compared in both groups. Intervenient features will be tested.Results:Data collection is ongoing and is expected to be completed by January 2025. A homogeneous sample and clear outcomes may be a highlight of this protocol, which may allow us to understand the potential use of tDCS and for whom it should or should not be used.Conclusions:A study with good evidence and clear outcomes in children with CP might open an avenue for the potential best use of neurostimulation.Trial Registration:Brazilian Registry of Clinical Trials RBR-104h4s4y; https://tinyurl.com/47r3x2e4International Registered Report Identifier (IRRID):PRR1-10.2196/52922
Author Lucarini, Beatriz
Romano-Silva, Marco Aurélio
Cangussu, Anna Izabel
Melo, Igor de Freitas
Diniz, Paula Araújo
Mancini, Marisa
Miranda, Débora Marques de
Viana, Bernardo de Mattos
AuthorAffiliation 1 Faculdade de Medicina da Universidade Federal de Minas Gerais Federal University of Minas Gerais Belo Horizonte Brazil
3 Departament of Occupational Therapy Universidade Federal de Minas Gerais Belo Horizonte Brazil
5 Departamento de Pediatria Faculdade de Medicina Universidade Federal de Minas Gerais Belo Horizonte Brazil
2 Instituto Nacional de Ciência e Tecnologia de Medicina Molecular Universidade Federal de Minas Gerais Belo Horinzote Brazil
4 Instituto Nacional de Ciência e Tecnologia Neurotech R Universidade Federal de Minas Gerais Belo Horizonte Brazil
AuthorAffiliation_xml – name: 3 Departament of Occupational Therapy Universidade Federal de Minas Gerais Belo Horizonte Brazil
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– name: 5 Departamento de Pediatria Faculdade de Medicina Universidade Federal de Minas Gerais Belo Horizonte Brazil
– name: 1 Faculdade de Medicina da Universidade Federal de Minas Gerais Federal University of Minas Gerais Belo Horizonte Brazil
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  givenname: Marco Aurélio
  orcidid: 0000-0002-6558-4639
  surname: Romano-Silva
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  surname: Miranda
  fullname: Miranda, Débora Marques de
  organization: Departamento de Pediatria, Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
BackLink https://www.ncbi.nlm.nih.gov/pubmed/38687586$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Copyright Anna Izabel Cangussu, Beatriz Lucarini, Igor de Freitas Melo, Paula Araújo Diniz, Marisa Mancini, Bernardo de Mattos Viana, Marco Aurélio Romano-Silva, Débora Marques de Miranda. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.04.2024.
2024. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
Anna Izabel Cangussu, Beatriz Lucarini, Igor de Freitas Melo, Paula Araújo Diniz, Marisa Mancini, Bernardo de Mattos Viana, Marco Aurélio Romano-Silva, Débora Marques de Miranda. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.04.2024. 2024
Copyright_xml – notice: Anna Izabel Cangussu, Beatriz Lucarini, Igor de Freitas Melo, Paula Araújo Diniz, Marisa Mancini, Bernardo de Mattos Viana, Marco Aurélio Romano-Silva, Débora Marques de Miranda. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.04.2024.
– notice: 2024. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
– notice: Anna Izabel Cangussu, Beatriz Lucarini, Igor de Freitas Melo, Paula Araújo Diniz, Marisa Mancini, Bernardo de Mattos Viana, Marco Aurélio Romano-Silva, Débora Marques de Miranda. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.04.2024. 2024
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Keywords clinical trial
motor
RCT
development
researcher
injuries
researchers
patients
randomized clinical trial
neurological injuries
transcranial direct current stimulation
brain stimulation
children
gait
tDCS
patient
cerebral palsy
physical therapy
injury
quality of life
randomized
child
stimulation
Language English
License Anna Izabel Cangussu, Beatriz Lucarini, Igor de Freitas Melo, Paula Araújo Diniz, Marisa Mancini, Bernardo de Mattos Viana, Marco Aurélio Romano-Silva, Débora Marques de Miranda. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.04.2024.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
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Snippet Children diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily living....
Background:Children diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily...
BACKGROUNDChildren diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily...
BackgroundChildren diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily...
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StartPage e52922
SubjectTerms Cerebral palsy
Cerebral Palsy - physiopathology
Cerebral Palsy - rehabilitation
Cerebral Palsy - therapy
Child
Child, Preschool
Electric stimulation therapy
Female
Fitness equipment
Humans
Intervention
Male
Mobility
Motor ability
Motor Skills - physiology
Participation
Pediatrics
Physical therapy
Physical Therapy Modalities
Protocol
Quality of Life
Randomized Controlled Trials as Topic
Rehabilitation
Transcranial Direct Current Stimulation - methods
Treatment Outcome
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Title Motor Effects of Intervention With Transcranial Direct Current Stimulation for Physiotherapy Treatment in Children With Cerebral Palsy: Protocol for a Randomized Clinical Trial
URI https://www.ncbi.nlm.nih.gov/pubmed/38687586
https://www.proquest.com/docview/3053995027
https://search.proquest.com/docview/3049719113
https://pubmed.ncbi.nlm.nih.gov/PMC11094605
https://doaj.org/article/2300d52a174a473b9ec5e84bed14c702
Volume 13
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