- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07769099
Musical Training: Promoting Brain Function in Children Who Have Survived Brain Tumours
13 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
236
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Joyce Chung
- Numer telefonu: +852 27666322
- E-mail: okjoyce.chung@polyu.edu.hk
Lokalizacje studiów
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Hong Kong, Hongkong
- The Hong Kong Children's Hospital, Hong Kong
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Kontakt:
- Vivian Yuen
- Numer telefonu: +852 35133193
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Inny: 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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Brak interwencji: Control
The control group will receive usual care for 52 weeks
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Nonverbal Intelligence Score as Measured by the Test of Nonverbal Intelligence, Fourth Edition (TONI-4)
Ramy czasowe: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
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.
|
At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
|
Digit Span Score (Forward + Backward)
Ramy czasowe: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Quality of life scores of the child participants
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
30 października 2026
Zakończenie podstawowe (Szacowany)
30 maja 2029
Ukończenie studiów (Szacowany)
30 października 2029
Daty rejestracji na studia
Pierwszy przesłany
10 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
17 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
17 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
13 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB-2025-673
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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