Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-02 @ 3:38 AM
Study NCT ID:
NCT06006767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-25
First Post:
2023-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rhythmic Handwriting Deficits and General Rhythmic Abilities in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019957', 'term': 'Motor Skills Disorders'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-01-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rhythm of handwriting movement', 'timeFrame': '1 day at First visit', 'description': "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)."}], 'secondaryOutcomes': [{'measure': 'The rhythmic variables', 'timeFrame': '1 day at First visit', 'description': '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).'}, {'measure': 'Speed of handwriting : abnormal peak velocity fluctuations during handwriting movement', 'timeFrame': '1 day at First visit', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': [': Developmental Coordination Disorder', 'Rhythm', 'Rhythmic skills', 'Handwriting'], 'conditions': ['Developmental Coordination Disorder']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'American Psychiatric Association (APA) (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.'}, {'pmid': '27443353', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24139714', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Expertise Collective INSERM (2019). Trouble développemental de la coordination ou dyspraxie, Paris : Les Editions EDP Sciences.'}, {'pmid': '22960066', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nThese 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.\n\nHowever, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'DCD children', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 7 to 10 inclusive\n* Children who can read and write\n* Diagnosis of DCD according to DSM-5 criteria (APA, 2015)\n* Native French speaker\n* Living with at least one parent\n\nExclusion Criteria:\n\n* Intellectual development disorder confirmed or suspected during the initial evaluation phase in the MPEA department.\n* Presence or suspected presence of a visual impairment at the root of the motor skills deficit.\n* Presence or suspected presence of a neurological motor disorder (e.g. sensory impairment, cerebral palsy, muscular dystrophy, degenerative disease).\n* Not affiliated to a social security scheme or not benefiting from such a scheme.\n* Absence of written, informed consent from parents.'}, 'identificationModule': {'nctId': 'NCT06006767', 'acronym': 'TDC-Rythme', 'briefTitle': 'Rhythmic Handwriting Deficits and General Rhythmic Abilities in Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Links Between Rhythmic Handwriting Deficits and General Rhythmic Abilities in Children With Developmental Coordination Disorder: a Pilot Study. TDC-Rythme', 'orgStudyIdInfo': {'id': 'RECHMPL23_0112'}}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital La Colombière - CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'NESENSOHN Jessica', 'role': 'CONTACT', 'email': 'j-nesensohn@chu-montpellier.fr', 'phone': '04 67 33 52 17'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}