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- Ensaio Clínico NCT07769099
Musical Training: Promoting Brain Function in Children Who Have Survived Brain Tumours
13 de agosto de 2026 atualizado por: Dr Joyce Chung, The Hong Kong Polytechnic University
Efficacy of a Musical Training Programme in Promoting Neuroplasticity in Children Who Have Survived Brain Tumours: a Randomized Controlled Trial
This study aims to understand whether learning music can help improve brain function and quality of life in children who have recovered from brain tumours.
A total of 236 children will join the study.
Some of them will receive regular medical care, while others will take part in a music training program using the ukulele.
The music program will last for one year and includes both in-person group classes and online individual sessions.
The investigators will assess how well the children can think, remember, and focus before and after the training.
The investigators will also ask about their daily life and well-being.
This study hopes to show that music training can be a fun and helpful way to support recovery in childhood brain tumour survivors.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
This randomized controlled trial aims to determine the efficacy of musical training in promoting neuroplasticity and enhancing the quality of life in children who have survived brain tumours.
A total of 236 participants will be recruited from Hong Kong Children's Hospital and Children's Cancer Foundation centres.
Participants in the intervention group will receive 52 weeks of musical training, consisting of 36 face-to-face small group sessions and 16 online individual sessions, while the control group will receive usual care.
The ukulele, chosen for its light weight, simple chords, and cheerful sound, will be used as the training instrument due to its accessibility and appeal to children.
Neuroplasticity will be assessed using a battery of standardized instruments, including the Test of This study aims to explore whether musical training can help improve brain function and quality of life in children who have survived brain tumours.
A total of 236 children will be recruited and randomly assigned to either an intervention group or a control group.
The intervention group will receive 52 weeks of ukulele-based musical training, which includes 36 face-to-face group sessions held at The Hong Kong Polytechnic University and 16 online individual sessions conducted at home.
The control group will receive usual care only.
The ukulele was chosen for its light weight, simple chords, and child-friendly sound, making it ideal for young learners.
To support families who may not be familiar with online tools, the investigators will provide user guides, video tutorials, and technical support.
The study will assess participants' brain function-including nonverbal intelligence, attention, memory, processing speed, and executive functioning-as well as their daily functioning and quality of life using standardized tests and questionnaires.
These assessments will be conducted before and after the intervention and at follow-up.
The investigators hope the results will show that musical training is a fun and effective way to support the neurological and emotional recovery of children after brain tumour treatment.
Tipo de estudo
Intervencional
Inscrição (Estimado)
236
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Joyce Chung
- Número de telefone: +852 27666322
- E-mail: okjoyce.chung@polyu.edu.hk
Locais de estudo
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Hong Kong, Hong Kong
- The Hong Kong Children's Hospital, Hong Kong
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Contato:
- Vivian Yuen
- Número de telefone: +852 35133193
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Completed cancer treatment at least 2 months previously,
- Aged 7-16 years,
- Able to speak Cantonese and read Chinese
- Have had no musical training since their cancer diagnosis
Exclusion Criteria:
- Have cancer recurrence or a second malignancy
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: The intervention group will receive 52 weeks of musical training, including face-to-face and online.
musical training
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52 weeks of musical training, consisting of (1) 36 weekly group based, face-to-face sessions, and (2) 16 weeks of weekly online individual sessions.
Each lasting 45 minutes to 1 hour.
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Sem intervenção: Control
The control group will receive usual care for 52 weeks
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Nonverbal Intelligence Score as Measured by the Test of Nonverbal Intelligence, Fourth Edition (TONI-4)
Prazo: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
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The Test of Nonverbal Intelligence, Fourth Edition (TONI-4) is a language-free measure of nonverbal intelligence, abstract reasoning, and problem-solving.The Index score (mean = 100, SD = 15) will be reported.
Higher scores indicate better nonverbal intelligence.
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At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
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Digit Span Score (Forward + Backward)
Prazo: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
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Digit Span (Digits Forward + Digits Backward) assesses attention and working memory.
The total score will be reported.
Higher scores indicate better attention and working memory performance.
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At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
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Memory Score as Measured by the Hong Kong List Learning Test, Second Edition (HKLLT-2)
Prazo: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
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The Hong Kong List Learning Test, Second Edition (HKLLT-2) assesses verbal memory.
The total recall / delayed recall score will be reported.
Higher scores indicate better memory performance.
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At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
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Processing Speed / Executive Function as Measured by the Children's Color Trails Test (CCTT)
Prazo: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
The Children's Color Trails Test (CCTT) assesses sustained attention, sequencing, and executive function.
Trail 1 involves connecting numbers (1-15) in sequence, while Trail 2 adds alternating between two colours.
Processing speed is estimated from Trail 1 time, while the interference index (Trail 2 minus Trail 1) reflects executive functions, including inhibitory control and cognitive flexibility.
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At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
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Executive Function as Measured by the Behaviour Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Prazo: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
The Behaviour Rating Inventory of Executive Function-2 is an assessment of executive function behaviours.
A Global Executive Composite (GEC) T-score (or specific index T-scores) will be given.
Higher T-scores mean more executive dysfunction.
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At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quality of life scores of the child participants
Prazo: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
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Measured by The Chinese version of the Paediatric Quality of Life Inventory (PedsQL)
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At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
30 de outubro de 2026
Conclusão Primária (Estimado)
30 de maio de 2029
Conclusão do estudo (Estimado)
30 de outubro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
10 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de agosto de 2026
Primeira postagem (Real)
17 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB-2025-673
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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