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临床试验/NCT07303049
NCT07303049尚未招募不适用

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

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
6
试验地点
2
主要终点
Rhythmic structure reproduction task (Stambak-type test)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
8 Years 至 126 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Rhythmic structure reproduction task (Stambak-type test)

时间窗: From week 2 after enrollment to week 14

次要结局

  • Behavioral observation grid in ecological settings (SCED methodology)(From week 2 after enrollment to week 14)
  • Visuospatial: Spatial memory task(Week 1 and week 17)
  • Pseudoword reading: Evaléo (ages 6-15)(Week 1 and week 17)
  • Text reading: Evaléo (ages 6-15), Forms A and B(Week 1 and week 17)
  • Spontaneous tempo tapping task (SCED methodology)(From week 2 after enrollment to week 14)
  • Implicit motor timing (emergent timing): WALS (Walk A Line Slowly)(Week 1 and week 17)
  • 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)
  • Explicit perceptual timing: Beat alignment task(Week 1 and 17)
  • Implicit motor timing (emergent timing): DALS (Draw A Line Slowly)(Week 1 and week 17)
  • Selective visual attention: Barre-Joe Test(Week 1 and week 17)
  • Auditory attention: Auditory attention and associated response test(Week 1 and week 17)
  • Planning: 8 Maze Test or Rey-Osterrieth Complex Figure with planning instructions(Week 1 and week 17)
  • Cognitive flexibility: Children's Card Sorting Test - KCST(Week 1 and week 17)
  • Inhibition: Child Tapping Test(Week 1 and week 17)
  • Auditory-verbal: Digit Span Task(Week 1 and week 17)
  • Test assessing passive lexical knowledge: Evaléo (ages 6-15)(Week 1 and week 17)
  • Rapid color naming task: Evaléo (ages 6-15)(Week 1 and week 17)
  • Tapping subtest from NEPSY-II(Week 1 and week 17)
  • Manual dexterity (MABC-2)(Week 1 and week 17)
  • Temporal questionnaire for children (QTE)(Week 1 and week 17)
  • MDI-C (Children's Depression Inventory: Self-esteem subscale, ages 8-17)(Week 1 and week 17)
  • Parent questionnaire: Strengths and Difficulties Questionnaire (SDQ-Fra)(Week 1 and week 17)
  • Child self-assessment from a predefined list of daily activities that may pose difficulties (ecological assessment)(Week 1 and week 17)
  • Likert scale assessing satisfaction across various criteria(Week 17 after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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