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Tratamento de EMTr para espasticidade em crianças com paralisia cerebral - um RCT
Estimulação magnética transcraniana repetitiva (EMTr) para o tratamento da espasticidade em crianças com paralisia cerebral hemiplégica - um ensaio clínico randomizado
This RCT aims to investigate the effect of repetitive transcranial magnatic stimulation (rTMS) in treating children with hemiplegoc cerebral palsy. The study will measure any improvement in spasticity after using contra-lesional inhibitory rTMS follow by intensive limb training.
Participants will attend a 10-day rTMS treatment sessions, follow by intensive training of the impaired limb. They will also undergo MRI scans before and after the treatment to investiagte the underlying neurophysiological mechanisms that lead to changes clinically by using TMS as well as MR-DKI. Researchers will compare the intervention group and the sham group to see if rTMS could result in improvement of participants' spasticity.
Visão geral do estudo
Status
Condições
Descrição detalhada
Cerebral palsy is the most common cause of lifelong physical disability in childhood, with an estimated prevalence of 1.5 per 1000 living biths for primary school-aged children. Spasticity is the most common symptoms in children with cerebral palsy, leading to muscle weakness affecting gross motor functions and causing complications such as pain, contracture and subluzation which will lead to inability to perform activity-based training and subsequently lead to further muscle weakness. Standard therapy with regular physiotherapy and occupational therapy are essential but time-consuming and the effects might not last for longer duration. Patients or caregivers decline medications because of side effects drowsiness while other interventions such as intra-thecal baclofen pump, rhizotomy or surgery are invasive.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has the ability to modulate excitation of the motor cortex area of the brain. There were past studies suggesting that using contralesional inhibitory rTMS was safe and feasible for patients with paediatric subcortical stroke and seemed to improve hand function in patients with hemiparesis. However, limited studies have been published on the effects of rTMS on improving spasticity in children with cerebral palsy. Hence, the objective of this study is to use low-frequency rTMS to the contra-lesional hemisphere in children with hemiplegic cerebral palsy to investigate if rTMS follow by intensive limb training would improve spasiticity of these children and whether the improvement can be sustained for a longer time. The underlying mechanisms that lead to the changes clinically will also be investigated by TMS and MRI.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Winnie Wan Yee Tso, MBBS
- Número de telefone: +85222554295
- E-mail: wytso@hku.hk
Estude backup de contato
- Nome: Chai Yin Charlie Fan, MPhil, OTR
- Número de telefone: +85222554375
- E-mail: charliefan@connect.hku.hk
Locais de estudo
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong, 0000
- Recrutamento
- Li Ka Shing Faculty of Medicine
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Contato:
- Charlie Fan, MPhil, OTR
- Número de telefone: +85222554375
- E-mail: charliefan@connect.hku.hk
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients aged between 4 years and 18 years
- Diagnosis of hemiplegia
- Upper limb spasticity ≥ 1
- IQ ≥ 50
Exclusion Criteria:
- Any contra-indications to rTMS
- Severe spasticity (score of 4 or more in Ashworth scale)
- Uncontrollable epilepsy
- History of Botulinum toxin A injection in previous 6 months
- Upper limb casting in previous 6 months
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Interventional rTMS group
The intervention group will receive 1 Hz active rTMS during treatment, lasting for 20 minutes, follow up by 1.5 hours of motor training. |
1 Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training. |
|
Comparador Falso: Sham rTMS group
The sham group will not receive any Hz of rTMS during treatment, also lasting for 20 minutes with 1.5 hours of motor training. |
Sham Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Modified Ashworth Scale
Prazo: Baseline, Day 10, 17 of intervention and 2 months post intervention
|
Clinical measure of spasticity. Scores range from 0 to 4, with a higher score indicate worse in muscle tone |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
|
The range of motion scores
Prazo: Baseline, Day 10, 17 of intervention and 2 months post intervention
|
ROM of thumb adduction, wrist dorsal flexion and extension, and elbow dorsal flexion and extension. Patients' range of motion score will be compared to the normative values |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
|
The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Prazo: Baseline, Day 10, 17 of intervention and 2 months post intervention
|
The BOT-2 provides a comprehensive overview of fine and gross motor skills in children and young adults within school age-range. |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Gross motor function measure
Prazo: Baseline, Day 10, 17 of intervention and 2 months post intervention
|
Changes in motor function. A 4-point Likert scale with higher score indicates better motor function |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
|
Pediatric Quality of Life Cerebral Palsy module
Prazo: Baseline, Day 10, 17 of intervention and 2 months post intervention
|
Quality of life measurement. Scores range from 0 to 100 with higher score indicate better quality of life. |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
|
MRI Brain: fMRI and DKI
Prazo: Baseline, Day 10, 17 of intervention and 2 months post intervention
|
Functional MRI and Diffusion Kurtosis Imaging measuring the brain microstructural changes and structural connectivity during the intervention |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
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Purdue Pegboard Test
Prazo: Baseline, Day 10, 17 of intervention and 2 months post intervention
|
A standardized evaluation tool used to measure gross movements of hands, fingers, and arms, as well as fine fingertip dexterity. |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças musculoesqueléticas
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Musculares
- Hipertonia muscular
- Manifestações Neuromusculares
- Dano Cerebral, Crônico
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Espasticidade muscular
- Paralisia cerebral
- Terapêutica
- Terapia de campo magnético
- Estimulação magnética transcraniana
Outros números de identificação do estudo
- rTMSCPHKU
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