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NCT Number: NCT07303049

Cognitive Benefit of Intensive Rehabilitation Using Rhythmic Music Training in Children With Complex Neurodevelopmental Disorder

In the wide range of studies carried out on neurodevelopmental disorders (NDD), rhythm disorders have been identified as a major cross-cutting component. The aim of our research is to evaluate the effect of intensive rhythm-based rehabilitation on rhythmic abilities and its generalization to attentional, executive and reading skills.

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Key information

Age range

8 year–126 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensive rhythmic musical training

Behavioral

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.

Primary outcomes

  1. Rhythmic structure reproduction task (Stambak-type test)

    Time frame: From week 2 after enrollment to week 14

Secondary outcomes

  1. Spontaneous tempo tapping task (SCED methodology)

    Time frame: From week 2 after enrollment to week 14

  2. Behavioral observation grid in ecological settings (SCED methodology)

    Time frame: From week 2 after enrollment to week 14

  3. Text reading task (speed/accuracy ratio) (SCED methodology)

    Time frame: From week 2 after enrollment to week 14

  4. Line orientation judgment task (SCED methodology)

    Time frame: From week 2 after enrollment to week 14

  5. Explicit sensorimotor timing: Synchronization tapping task with a metronome

    Time frame: Week 1 and week 17

  6. Explicit perceptual timing: Beat alignment task

    Time frame: Week 1 and 17

  7. Implicit motor timing (emergent timing): DALS (Draw A Line Slowly)

    Time frame: Week 1 and week 17

  8. Implicit motor timing (emergent timing): WALS (Walk A Line Slowly)

    Time frame: Week 1 and week 17

  9. Selective visual attention: Barre-Joe Test

    Time frame: Week 1 and week 17

  10. Auditory attention: Auditory attention and associated response test

    Time frame: Week 1 and week 17

  11. Planning: 8 Maze Test or Rey-Osterrieth Complex Figure with planning instructions

    Time frame: Week 1 and week 17

  12. Cognitive flexibility: Children's Card Sorting Test - KCST

    Time frame: Week 1 and week 17

  13. Inhibition: Child Tapping Test

    Time frame: Week 1 and week 17

  14. Auditory-verbal: Digit Span Task

    Time frame: Week 1 and week 17

  15. Visuospatial: Spatial memory task

    Time frame: Week 1 and week 17

  16. Pseudoword reading: Evaléo (ages 6-15)

    Time frame: Week 1 and week 17

  17. Text reading: Evaléo (ages 6-15), Forms A and B

    Time frame: Week 1 and week 17

  18. Test assessing passive lexical knowledge: Evaléo (ages 6-15)

    Time frame: Week 1 and week 17

  19. Rapid color naming task: Evaléo (ages 6-15)

    Time frame: Week 1 and week 17

  20. Tapping subtest from NEPSY-II

    Time frame: Week 1 and week 17

  21. Manual dexterity (MABC-2)

    Time frame: Week 1 and week 17

  22. Temporal questionnaire for children (QTE)

    Time frame: Week 1 and week 17

  23. MDI-C (Children's Depression Inventory: Self-esteem subscale, ages 8-17)

    Time frame: Week 1 and week 17

  24. Parent questionnaire: Strengths and Difficulties Questionnaire (SDQ-Fra)

    Time frame: Week 1 and week 17

  25. Child self-assessment from a predefined list of daily activities that may pose difficulties (ecological assessment)

    Time frame: Week 1 and week 17

  26. Likert scale assessing satisfaction across various criteria

    Time frame: Week 17 after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Céline CHIGNAC

CONTACT

[email protected]

05 67 77 10 93

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: CHUpercu

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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