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HAND-IN (hand function after neuromodulation and intensive training in children with cerebral palsy): study protocol for a randomized, triple-blind, controlled trial with embedded implementation and cost-effectiveness analyses.

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Τίτλος: HAND-IN (hand function after neuromodulation and intensive training in children with cerebral palsy): study protocol for a randomized, triple-blind, controlled trial with embedded implementation and cost-effectiveness analyses.
Συγγραφείς: Vancetto Maglione A; Physical Therapist, Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil., Firmo Dos Santos J; Physical Therapist, Associação de Assistência à Criança Deficiente, São Paulo, Brazil., Rodrigues da Silva AC; Occupational Therapist, Associação de Assistência à Criança Deficiente, São Paulo, Brazil., Roveron Souto LE; Physical Therapist, Associação de Assistência à Criança Deficiente, São Paulo, Brazil., da Silva Matuti G; Physical Therapist, Associação de Assistência à Criança Deficiente, São Paulo, Brazil., Wentz Moura E; Supervisor of the Pediatric Physical Therapy Sector at Associação de Assistência à Criança Deficiente, São Paulo, Brazil., Costa Cespedes M; Clinical Neurophysiologist at the Department of Neurology and Neurosurgery, Federal University of São Paulo (UNIFESP-SP), São Paulo, Brazil., Uchida CGP; Clinical Neurophysiologist at the Department of Neurology and Neurosurgery, Head of the Electroencephalography Unit, Federal University of São Paulo (UNIFESP-SP), São Paulo, Brazil., Oliveira ASB; Neurologist in Charge of the Neuromuscular Diseases Unit, The Federal University of São Paulo (UNIFESP-SP), São Paulo, Brazil., Alouche SR; Physical Therapist, Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.
Πηγή: Expert review of neurotherapeutics [Expert Rev Neurother] 2026 Oct; Vol. 26 (10), pp. 1017-1026. Date of Electronic Publication: 2026 Sep 03.
Τύπος έκδοσης: Journal Article; Clinical Trial Protocol
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Taylor & Francis Country of Publication: England NLM ID: 101129944 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1744-8360 (Electronic) Linking ISSN: 14737175 NLM ISO Abbreviation: Expert Rev Neurother Subsets: MEDLINE
Imprint Name(s): Publication: 2015- : Abingdon, Oxford : Taylor & Francis
Original Publication: London : Future Drugs Ltd., 2001-
Ιατρικοί όροι (MeSH): Cerebral Palsy*/therapy , Cerebral Palsy*/physiopathology , Cerebral Palsy*/rehabilitation , Transcranial Direct Current Stimulation*/methods , Constraint Induced Movement Therapy*/methods , Hand*/physiopathology , Transcranial Magnetic Stimulation*, Humans ; Child ; Adolescent ; Cost-Benefit Analysis ; Randomized Controlled Trials as Topic ; Cost-Effectiveness Analysis ; Female ; Male
Περίληψη: Aim: The following clinical trial protocol aims to investigate the additional effects of bilateral transcranial direct current stimulation (tDCS) combined with constraint-induced movement therapy (CIMT) compared to CIMT alone in children and adolescents with spastic hemiparetic cerebral palsy.
Methods: This randomized, triple-blind, controlled trial will enroll 32 participants aged 7-16 years with spastic hemiparetic cerebral palsy (MACS I-II). Participants will be allocated to CIMT with sham or active bilateral tDCS (C3-C4, 1 mA, 20 min), with electrode placement guided by transcranial magnetic stimulation mapping. The intervention will last 3 weeks (5 days/week, 3 h/day). Primary outcomes will assess upper limb use (PMAL/TMAL). Secondary outcomes include dexterity (Box and Block Test), strength (dynamometry), functional performance (PAFT), and participation (COPM, GAS). Assessments will occur post-intervention and at 1, 3, and 6 months. Implementation of outcomes and cost-effectiveness will also be evaluated. Once completed, the study team will perform intention-to-treat analyses using linear mixed-effects models.
Expected Results: The HAND-IN trial will provide evidence on the clinical, implementation, and economic effects of combining CIMT with bilateral tDCS in children with spastic hemiparetic cerebral palsy. If effective, this approach may enhance the durability of upper limb functional gains and support the adoption of neuromodulation in pediatric neurorehabilitation.Trial Registration Number (Brazilian Clinical Trials Record- REBEC): RBR-2fczbt2 (https://ensaiosclinicos.gov.br/rg/RBR-2fczbt2). Registration on January 15, 2026.
Contributed Indexing: Keywords: Cerebral palsy; Neurological Rehabilitation; constraint-induced movement therapy; transcranial direct current stimulation; upper limb
Entry Date(s): Date Created: 20260904 Date Completed: 20261002 Latest Revision: 20261005
Update Code: 20261006
DOI: 10.1080/14737175.2026.2727670
PMID: 42693609
Βάση Δεδομένων: MEDLINE
FullText Text:
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PubType: Academic Journal
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  Data: HAND-IN (hand function after neuromodulation and intensive training in children with cerebral palsy): study protocol for a randomized, triple-blind, controlled trial with embedded implementation and cost-effectiveness analyses.
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  Data: <searchLink fieldCode="AU" term="%22Vancetto+Maglione+A%22">Vancetto Maglione A</searchLink>; Physical Therapist, Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Firmo+Dos+Santos+J%22">Firmo Dos Santos J</searchLink>; Physical Therapist, Associação de Assistência à Criança Deficiente, São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Rodrigues+da+Silva+AC%22">Rodrigues da Silva AC</searchLink>; Occupational Therapist, Associação de Assistência à Criança Deficiente, São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Roveron+Souto+LE%22">Roveron Souto LE</searchLink>; Physical Therapist, Associação de Assistência à Criança Deficiente, São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22da+Silva+Matuti+G%22">da Silva Matuti G</searchLink>; Physical Therapist, Associação de Assistência à Criança Deficiente, São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Wentz+Moura+E%22">Wentz Moura E</searchLink>; Supervisor of the Pediatric Physical Therapy Sector at Associação de Assistência à Criança Deficiente, São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Costa+Cespedes+M%22">Costa Cespedes M</searchLink>; Clinical Neurophysiologist at the Department of Neurology and Neurosurgery, Federal University of São Paulo (UNIFESP-SP), São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Uchida+CGP%22">Uchida CGP</searchLink>; Clinical Neurophysiologist at the Department of Neurology and Neurosurgery, Head of the Electroencephalography Unit, Federal University of São Paulo (UNIFESP-SP), São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Oliveira+ASB%22">Oliveira ASB</searchLink>; Neurologist in Charge of the Neuromuscular Diseases Unit, The Federal University of São Paulo (UNIFESP-SP), São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Alouche+SR%22">Alouche SR</searchLink>; Physical Therapist, Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.
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  Data: <searchLink fieldCode="JN" term="%22101129944%22">Expert review of neurotherapeutics</searchLink> [Expert Rev Neurother] 2026 Oct; Vol. 26 (10), pp. 1017-1026. <i>Date of Electronic Publication: </i>2026 Sep 03.
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  Data: Journal Article; Clinical Trial Protocol
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Taylor+%26+Francis%22">Taylor & Francis </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101129944 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1744-8360 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2214737175%22">14737175 </searchLink><i>NLM ISO Abbreviation: </i>Expert Rev Neurother <i>Subsets: </i>MEDLINE
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  Data: <i>Publication</i>: 2015- : Abingdon, Oxford : Taylor & Francis<br /><i>Original Publication</i>: London : Future Drugs Ltd., 2001-
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  Data: <searchLink fieldCode="MM" term="%22Cerebral+Palsy%22">Cerebral Palsy*</searchLink>/<searchLink fieldCode="MM" term="%22Cerebral+Palsy+therapy%22">therapy</searchLink> <br /><searchLink fieldCode="MM" term="%22Cerebral+Palsy%22">Cerebral Palsy*</searchLink>/<searchLink fieldCode="MM" term="%22Cerebral+Palsy+physiopathology%22">physiopathology</searchLink> <br /><searchLink fieldCode="MM" term="%22Cerebral+Palsy%22">Cerebral Palsy*</searchLink>/<searchLink fieldCode="MM" term="%22Cerebral+Palsy+rehabilitation%22">rehabilitation</searchLink> <br /><searchLink fieldCode="MM" term="%22Transcranial+Direct+Current+Stimulation%22">Transcranial Direct Current Stimulation*</searchLink>/<searchLink fieldCode="MM" term="%22Transcranial+Direct+Current+Stimulation+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Constraint+Induced+Movement+Therapy%22">Constraint Induced Movement Therapy*</searchLink>/<searchLink fieldCode="MM" term="%22Constraint+Induced+Movement+Therapy+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Hand%22">Hand*</searchLink>/<searchLink fieldCode="MM" term="%22Hand+physiopathology%22">physiopathology</searchLink> <br /><searchLink fieldCode="MM" term="%22Transcranial+Magnetic+Stimulation%22">Transcranial Magnetic Stimulation*</searchLink><br /><searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Child%22">Child</searchLink> ; <searchLink fieldCode="MH" term="%22Adolescent%22">Adolescent</searchLink> ; <searchLink fieldCode="MH" term="%22Cost-Benefit+Analysis%22">Cost-Benefit Analysis</searchLink> ; <searchLink fieldCode="MH" term="%22Randomized+Controlled+Trials+as+Topic%22">Randomized Controlled Trials as Topic</searchLink> ; <searchLink fieldCode="MH" term="%22Cost-Effectiveness+Analysis%22">Cost-Effectiveness Analysis</searchLink> ; <searchLink fieldCode="MH" term="%22Female%22">Female</searchLink> ; <searchLink fieldCode="MH" term="%22Male%22">Male</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: Aim: The following clinical trial protocol aims to investigate the additional effects of bilateral transcranial direct current stimulation (tDCS) combined with constraint-induced movement therapy (CIMT) compared to CIMT alone in children and adolescents with spastic hemiparetic cerebral palsy.<br />Methods: This randomized, triple-blind, controlled trial will enroll 32 participants aged 7-16 years with spastic hemiparetic cerebral palsy (MACS I-II). Participants will be allocated to CIMT with sham or active bilateral tDCS (C3-C4, 1 mA, 20 min), with electrode placement guided by transcranial magnetic stimulation mapping. The intervention will last 3 weeks (5 days/week, 3 h/day). Primary outcomes will assess upper limb use (PMAL/TMAL). Secondary outcomes include dexterity (Box and Block Test), strength (dynamometry), functional performance (PAFT), and participation (COPM, GAS). Assessments will occur post-intervention and at 1, 3, and 6 months. Implementation of outcomes and cost-effectiveness will also be evaluated. Once completed, the study team will perform intention-to-treat analyses using linear mixed-effects models.<br />Expected Results: The HAND-IN trial will provide evidence on the clinical, implementation, and economic effects of combining CIMT with bilateral tDCS in children with spastic hemiparetic cerebral palsy. If effective, this approach may enhance the durability of upper limb functional gains and support the adoption of neuromodulation in pediatric neurorehabilitation.Trial Registration Number (Brazilian Clinical Trials Record- REBEC): RBR-2fczbt2 (https://ensaiosclinicos.gov.br/rg/RBR-2fczbt2). Registration on January 15, 2026.
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  Data: <i>Keywords: </i>Cerebral palsy; Neurological Rehabilitation; constraint-induced movement therapy; transcranial direct current stimulation; upper limb
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  Data: <i>Date Created: </i>20260904 <i>Date Completed: </i>20261002 <i>Latest Revision: </i>20261005
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  Data: 10.1080/14737175.2026.2727670
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