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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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. |
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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 – name: 4 Instituto Nacional de Ciência e Tecnologia Neurotech R Universidade Federal de Minas Gerais Belo Horizonte Brazil – name: 2 Instituto Nacional de Ciência e Tecnologia de Medicina Molecular Universidade Federal de Minas Gerais Belo Horinzote Brazil – 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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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 |
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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 |
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References | Castelli, E (ref7) 2016; 52 ref13 ref12 ref15 ref14 ref20 ref10 Aran, A (ref19) 2010 ref2 ref1 ref17 ref16 Russel, DJ (ref11) 2021 ref18 ref8 ref4 ref3 ref6 ref5 Vitrikas, K (ref9) 2020; 101 |
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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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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 |
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