- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07769099
Musical Training: Promoting Brain Function in Children Who Have Survived Brain Tumours
13 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
236
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Joyce Chung
- Telefonnummer: +852 27666322
- E-post: okjoyce.chung@polyu.edu.hk
Studieorter
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-
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Hong Kong, Hong Kong
- The Hong Kong Children's Hospital, Hong Kong
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Kontakt:
- Vivian Yuen
- Telefonnummer: +852 35133193
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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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Inget ingripande: Control
The control group will receive usual care for 52 weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Nonverbal Intelligence Score as Measured by the Test of Nonverbal Intelligence, Fourth Edition (TONI-4)
Tidsram: 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)
Tidsram: 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.
|
At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
|
Memory Score as Measured by the Hong Kong List Learning Test, Second Edition (HKLLT-2)
Tidsram: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
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.
|
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)
Tidsram: 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)
Tidsram: 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.
|
At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of life scores of the child participants
Tidsram: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
Measured by The Chinese version of the Paediatric Quality of Life Inventory (PedsQL)
|
At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 oktober 2026
Primärt slutförande (Beräknad)
30 maj 2029
Avslutad studie (Beräknad)
30 oktober 2029
Studieregistreringsdatum
Först inskickad
10 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
13 augusti 2026
Första postat (Faktisk)
17 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB-2025-673
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