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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06006767
Other study ID # RECHMPL23_0112
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 16, 2023
Est. completion date January 17, 2026

Study information

Verified date August 2023
Source University Hospital, Montpellier
Contact NESENSOHN Jessica
Phone 04 67 33 52 17
Email j-nesensohn@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with Developmental Coordination Disorder (DCD), a neurodevelopmental disorder that affects motor skills and motor learning (APA, 2013), have been reported to manifest rhythmic deficits in handwriting domain, as well as general rhythmic deficits (i.e., regardless handwriting context per se) (Rosenblum & Regev, 2013). Accordingly, children with DCD struggle in tasks like synchronising to an external musical rhythm (in rhythm production tasks) or even in discrimination tasks such as detecting beat deviations, i.e., in rhythm perception tasks (INSERM collective expertise, 2019). These rhythmic deficits which manifest in a variety of tasks and conditions support the hypothesis of a "generalised dysrhythmia" in DCD, according to which the rhythmic deficits - in perceptual tasks and motor production - could have a common source, namely a mechanism devoted to rhythm processing (a cerebral mechanism involved in the perception of rhythm) and independent of the effectors involved and the type of task considered. However, the nature of the relationships between general rhythmic skills (perceptual and motor) and rhythmic abilities when engaged in handwriting movement is largely unknown in DCD. Whether a common source drives these diverse rhythmic deficits remains to explore. If this hypothesis were to be confirmed, this would pave the way for innovative therapeutic tools (e.g., serious games) for training a central rhythmic processing mechanism (rhythm perception), which could positively impact in turn rhythmicity of thandwriting movement in this population.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 55
Est. completion date January 17, 2026
Est. primary completion date July 16, 2025
Accepts healthy volunteers No
Gender All
Age group 7 Years to 10 Years
Eligibility Inclusion Criteria: - Children aged 7 to 10 inclusive - Children who can read and write - Diagnosis of DCD according to DSM-5 criteria (APA, 2015) - Native French speaker - Living with at least one parent Exclusion Criteria: - Intellectual development disorder confirmed or suspected during the initial evaluation phase in the MPEA department. - Presence or suspected presence of a visual impairment at the root of the motor skills deficit. - Presence or suspected presence of a neurological motor disorder (e.g. sensory impairment, cerebral palsy, muscular dystrophy, degenerative disease). - Not affiliated to a social security scheme or not benefiting from such a scheme. - Absence of written, informed consent from parents.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hôpital La Colombière - CHU de Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (5)

American Psychiatric Association (APA) (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.

Dalla Bella S, Farrugia N, Benoit CE, Begel V, Verga L, Harding E, Kotz SA. BAASTA: Battery for the Assessment of Auditory Sensorimotor and Timing Abilities. Behav Res Methods. 2017 Jun;49(3):1128-1145. doi: 10.3758/s13428-016-0773-6. — View Citation

Danna J, Paz-Villagran V, Velay JL. Signal-to-noise velocity peaks difference: a new method for evaluating the handwriting movement fluency in children with dysgraphia. Res Dev Disabil. 2013 Dec;34(12):4375-84. doi: 10.1016/j.ridd.2013.09.012. Epub 2013 Oct 18. — View Citation

Expertise Collective INSERM (2019). Trouble développemental de la coordination ou dyspraxie, Paris : Les Editions EDP Sciences.

Rosenblum S, Regev N. Timing abilities among children with developmental coordination disorders (DCD) in comparison to children with typical development. Res Dev Disabil. 2013 Jan;34(1):218-27. doi: 10.1016/j.ridd.2012.07.011. Epub 2012 Sep 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The rhythm of handwriting movement measured by the variability of the handwriting movement frequency, obtained by calculating the inverse of the period of the strokes (local minima of speed) from the children's writing productions on a graphic tablet (Danna et al., 2013). 1 day at First visit
Secondary The rhythmic variables Perceptual and motor rhythmic skills out of context of handwriting, obtained from the assessment of rhythmic skills using the gold-standard BAASTA battery (Dalla Bella et al., 2017). 1 day at First visit
Secondary Speed of handwriting : abnormal peak velocity fluctuations during handwriting movement Abnormal variations of the speed peaks during the writing movement are processed from the raw or transformed data according to the same conditions as in BHK test condition depending on the normality or non-normality of data. 1 day at First visit
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