- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07769099
Musical Training: Promoting Brain Function in Children Who Have Survived Brain Tumours
13 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
236
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Joyce Chung
- Numero di telefono: +852 27666322
- Email: okjoyce.chung@polyu.edu.hk
Luoghi di studio
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Hong Kong, Hong Kong
- The Hong Kong Children's Hospital, Hong Kong
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Contatto:
- Vivian Yuen
- Numero di telefono: +852 35133193
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: 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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Nessun intervento: Control
The control group will receive usual care for 52 weeks
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Nonverbal Intelligence Score as Measured by the Test of Nonverbal Intelligence, Fourth Edition (TONI-4)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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 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)
Lasso di tempo: 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 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Quality of life scores of the child participants
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
30 ottobre 2026
Completamento primario (Stimato)
30 maggio 2029
Completamento dello studio (Stimato)
30 ottobre 2029
Date di iscrizione allo studio
Primo inviato
10 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
13 agosto 2026
Primo Inserito (Effettivo)
17 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB-2025-673
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .