NCT07303049

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 11, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

Complex neurodevelopmental disorderIntensive rhythmic rehabilitationCognitionSCEDChildren

Outcome Measures

Primary Outcomes (1)

  • Rhythmic structure reproduction task (Stambak-type test)

    From week 2 after enrollment to week 14

Secondary Outcomes (26)

  • Spontaneous tempo tapping task (SCED methodology)

    From week 2 after enrollment to week 14

  • Behavioral observation grid in ecological settings (SCED methodology)

    From week 2 after enrollment to week 14

  • Text reading task (speed/accuracy ratio) (SCED methodology)

    From week 2 after enrollment to week 14

  • Line orientation judgment task (SCED methodology)

    From week 2 after enrollment to week 14

  • Explicit sensorimotor timing: Synchronization tapping task with a metronome

    Week 1 and week 17

  • +21 more secondary outcomes

Study Arms (1)

Children with complex neurodevelopmental disorders undergoing intensive rhythmic musical training

EXPERIMENTAL
Behavioral: Intensive rhythmic musical training

Interventions

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.

Children with complex neurodevelopmental disorders undergoing intensive rhythmic musical training

Eligibility Criteria

Age8 Years - 126 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Purpan

Toulouse, Occitanie, 31300, France

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2025

First Posted

December 24, 2025

Study Start

January 1, 2026

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

December 24, 2025

Record last verified: 2025-12

Locations