- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07303049
Cognitive Benefit of Intensive Rehabilitation Using Rhythmic Music Training in Children With Complex Neurodevelopmental Disorder (CHUpercu)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Current knowledge of impaired rhythmic skills in NDD is based on a number of studies, mainly carried out with groups of children presenting either Attention Deficit Disorder with or without Hyperactivity (ADHD), Developmental Coordination Disorder (DCD) or Learning to Read Disorder (dyslexia, DYS). The authors highlighted an impairment of the temporal sphere, and more specifically a timing deficit. A few studies have already evaluated the effect of rhythm-based rehabilitation in children with isolated NDD (Flaugnacco et al., 2015; Habib et al., 2013; Jamey et al., 2024; Puyjarinet et al., 2020) and show an improvement in certain untrained cognitive functions (reading skills, phonological awareness, attention, working memory, inhibition).
The intervention, in groups of 6 children, takes place face-to-face, during a school vacation period over 5 consecutive days, 4 hours per day. The sessions are based on specific multimodal training and motor response using the djembe.
After an inclusion visit, all patients undergo a full neuropsychological assessment, which is repeated 2 months later (before-after design). These measurements will take place over one day at the Toulouse University Hospital, in person.
In the meantime, measurements of the assessment criteria are repeated daily before, during and after the intervention, according to a Single Case Experimental Design (SCED). Daily assessments, excluding weekends, will be performed and recorded via the Toulouse University Hospital's TéléO tool. A 5-days final evaluation phase will be carried out 3 months after the intervention to assess long-term effects.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Céline CHIGNAC
- Phone Number: 05 67 77 10 93
- Email: chignac.c@chu-toulouse.fr
Study Locations
-
-
Occitanie
-
Toulouse, Occitanie, France, 31300
- Hopital Purpan
-
Contact:
- Céline CHIGNAC
- Phone Number: 05 67 77 10 93
- Email: chignac.c@chu-toulouse.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of neurodevelopmental disorder involving at least two impairments (ADHD + DCD, ADHD + Dyslexia, Dyslexia + DCD, ADHD + Dyslexia + DCD), according to DSM-5 criteria (2015), established at the Language and Learning Disorders Reference Center (CRTLA) of Toulouse University Hospital.
- Aged between 8 years and 10 years 6 months.
- Enrolled in elementary school.
- Visual, auditory (with permitted aids), motor, oral and written expression and comprehension abilities sufficient, according to the investigator physician's assessment, to perform cognitive tests and follow the intervention.
- Patient beneficiary/affiliate of the French Social Security system.
- Signed informed consent from parent(s) / legal guardian(s) in accordance with French law and Good Clinical Practice, along with minor's assent.
- Authorization for image and sound recording.
Exclusion Criteria:
- Practice of a musical instrument during the current year (in a music school or leisure activity).
- Behavioral disorder making group practice difficult (e.g., oppositional defiant disorder) according to the investigator's opinion.
- Patient diagnosed with autism spectrum disorder or intellectual developmental disorder (IQ < 70).
- Patient with epilepsy (with or without treatment).
- Uncorrected hearing or visual impairment.
- Current treatment with psychostimulants or psychotropic drugs (notably methylphenidate, antidepressants).
- Patient lacking access to a stable internet connection required for teleconsultation assessments.
- Any family or sociological condition preventing compliance with the procedures outlined in the study protocol, according to the investigator's opinion.
- Patient participating in another human research study involving experimental treatment or behavioral therapy.
- Ongoing rehabilitative care is not an exclusion criterion for the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Children with complex neurodevelopmental disorders undergoing intensive rhythmic musical training
|
Participants undergo an intensive rhythmic training program using percussion instruments.
The program takes place over one week, with daily sessions focused on rhythmic exercises.
It focuses on developing motor coordination, timing, and cognitive skills through group-based rhythmic exercises and activities.
Sessions include guided percussion practice designed to improve sensorimotor integration and enhance cognitive-motor performance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rhythmic structure reproduction task (Stambak-type test)
Time Frame: From week 2 after enrollment to week 14
|
From week 2 after enrollment to week 14
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Spontaneous tempo tapping task (SCED methodology)
Time Frame: From week 2 after enrollment to week 14
|
From week 2 after enrollment to week 14
|
|
Behavioral observation grid in ecological settings (SCED methodology)
Time Frame: From week 2 after enrollment to week 14
|
From week 2 after enrollment to week 14
|
|
Text reading task (speed/accuracy ratio) (SCED methodology)
Time Frame: From week 2 after enrollment to week 14
|
From week 2 after enrollment to week 14
|
|
Line orientation judgment task (SCED methodology)
Time Frame: From week 2 after enrollment to week 14
|
From week 2 after enrollment to week 14
|
|
Explicit sensorimotor timing: Synchronization tapping task with a metronome
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Explicit perceptual timing: Beat alignment task
Time Frame: Week 1 and 17
|
Week 1 and 17
|
|
Implicit motor timing (emergent timing): DALS (Draw A Line Slowly)
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Implicit motor timing (emergent timing): WALS (Walk A Line Slowly)
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Selective visual attention: Barre-Joe Test
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Auditory attention: Auditory attention and associated response test
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Planning: 8 Maze Test or Rey-Osterrieth Complex Figure with planning instructions
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Cognitive flexibility: Children's Card Sorting Test - KCST
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Inhibition: Child Tapping Test
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Auditory-verbal: Digit Span Task
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Visuospatial: Spatial memory task
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Pseudoword reading: Evaléo (ages 6-15)
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Text reading: Evaléo (ages 6-15), Forms A and B
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Test assessing passive lexical knowledge: Evaléo (ages 6-15)
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Rapid color naming task: Evaléo (ages 6-15)
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Tapping subtest from NEPSY-II
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Manual dexterity (MABC-2)
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Temporal questionnaire for children (QTE)
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
MDI-C (Children's Depression Inventory: Self-esteem subscale, ages 8-17)
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Parent questionnaire: Strengths and Difficulties Questionnaire (SDQ-Fra)
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Child self-assessment from a predefined list of daily activities that may pose difficulties (ecological assessment)
Time Frame: Week 1 and week 17
|
Week 1 and week 17
|
|
Likert scale assessing satisfaction across various criteria
Time Frame: Week 17 after enrollment
|
Week 17 after enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RC31/24/0541
- ID-RCB : 2025-A01672-47 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Complex Neurodevelopmental Disorder
-
City, University of LondonCompletedCerebral Palsy | Complex Neurodevelopmental DisorderUnited Kingdom
-
Sofie FolkeAarhus University Hospital; Copenhagen Trial Unit, Center for Clinical Intervention... and other collaboratorsNot yet recruiting
-
University of PittsburghRecruitingNeurodevelopmental Disorders | SMN Complex Proteins | GEMIN5 Protein, HumanUnited States
-
Blinklab LimitedRecruitingAutism Spectrum Disorder | Autism | Neurodevelopmental Conditions | Autism Spectrum Disorder (ASD)United States
-
NeuroModulation Technique Research InstituteCompletedAutism | Neurodevelopmental DisorderUnited States
-
GRIN Therapeutics, Inc.Aziende Chimiche Riunite Angelini Francesco S.p.ARecruitingGRIN-related Neurodevelopmental DisorderUnited States
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedEpilepsy | Epilepsies, Partial | Partial Seizure Disorder | Complex Partial Seizure DisorderCosta Rica, Peru, El Salvador, Guatemala
-
University of StrathclydeGöteborg University; University of Aberdeen; University of Glasgow; HarimataCompletedAutism Spectrum Disorder | Other Neurodevelopmental DisorderSweden, United Kingdom
-
University Hospital, Clermont-FerrandNot yet recruitingNeurodevelopmental Disorder (Diagnosis)France
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinRecruitingNeurodevelopmental Disorders | Autism Spectrum Disorder | Attention Deficit Hyperactivity Disorder | Atypical Neurodevelopmental DisorderFrance
Clinical Trials on Intensive rhythmic musical training
-
Assistance Publique Hopitaux De MarseilleUnknown
-
The University of Hong KongCompleted
-
University Hospital, Basel, SwitzerlandCompleted
-
Hospital Universitario La PazNot yet recruitingDeafness; Perception, Bilateral
-
Chinese University of Hong KongAlice Ho Miu Ling Nethersole HospitalCompleted
-
The University of Hong KongCompleted
-
The Hong Kong Polytechnic UniversityHealth and Medical Research FundCompletedMusical Training Programme to Improve Neurocognitive Functioning of Children Surviving Brain TumoursBrain Tumor | Cancer ChildhoodHong Kong
-
University of Castilla-La ManchaCompletedPhysical Conditioning, HumanSpain
-
The University of Hong KongCompletedChild | Brain NeoplasmsChina
-
University of Southern CaliforniaOhio State University; University of California, MercedCompletedHearing Loss | Cochlear ImplantsUnited States