xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06006767</url>
    </required_header>
    <id_info>
      <org_study_id>RECHMPL23_0112</org_study_id>
      <nct_id>NCT06006767</nct_id>
    </id_info>
    <brief_title>Rhythmic Handwriting Deficits and General Rhythmic Abilities in Children</brief_title>
    <acronym>TDC-Rythme</acronym>
    <official_title>Links Between Rhythmic Handwriting Deficits and General Rhythmic Abilities in Children With Developmental Coordination Disorder: a Pilot Study. TDC-Rythme</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Montpellier</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Montpellier</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Patients with Developmental Coordination Disorder (DCD), a neurodevelopmental disorder that&#xD;
        affects motor skills and motor learning (APA, 2013), have been reported to manifest rhythmic&#xD;
        deficits in handwriting domain, as well as general rhythmic deficits (i.e., regardless&#xD;
        handwriting context per se) (Rosenblum &amp; Regev, 2013). Accordingly, children with DCD&#xD;
        struggle in tasks like synchronising to an external musical rhythm (in rhythm production&#xD;
        tasks) or even in discrimination tasks such as detecting beat deviations, i.e., in rhythm&#xD;
        perception tasks (INSERM collective expertise, 2019).&#xD;
  &#xD;
        These rhythmic deficits which manifest in a variety of tasks and conditions support the&#xD;
        hypothesis of a &quot;generalised dysrhythmia&quot; in DCD, according to which the rhythmic deficits -&#xD;
        in perceptual tasks and motor production - could have a common source, namely a mechanism&#xD;
        devoted to rhythm processing (a cerebral mechanism involved in the perception of rhythm) and&#xD;
        independent of the effectors involved and the type of task considered.&#xD;
  &#xD;
        However, the nature of the relationships between general rhythmic skills (perceptual and&#xD;
        motor) and rhythmic abilities when engaged in handwriting movement is largely unknown in DCD.&#xD;
        Whether a common source drives these diverse rhythmic deficits remains to explore. If this&#xD;
        hypothesis were to be confirmed, this would pave the way for innovative therapeutic tools&#xD;
        (e.g., serious games) for training a central rhythmic processing mechanism (rhythm&#xD;
        perception), which could positively impact in turn rhythmicity of thandwriting movement in&#xD;
        this population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 16, 2023</start_date>
    <completion_date type="Anticipated">January 17, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 16, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The rhythm of handwriting movement</measure>
      <time_frame>1 day at First visit</time_frame>
      <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).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The rhythmic variables</measure>
      <time_frame>1 day at First visit</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Speed of handwriting : abnormal peak velocity fluctuations during handwriting movement</measure>
      <time_frame>1 day at First visit</time_frame>
      <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.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Developmental Coordination Disorder</condition>
    <eligibility>
      <study_pop>
        <textblock>
          DCD children&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children aged 7 to 10 inclusive&#xD;
  &#xD;
            -  Children who can read and write&#xD;
  &#xD;
            -  Diagnosis of DCD according to DSM-5 criteria (APA, 2015)&#xD;
  &#xD;
            -  Native French speaker&#xD;
  &#xD;
            -  Living with at least one parent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intellectual development disorder confirmed or suspected during the initial evaluation&#xD;
               phase in the MPEA department.&#xD;
  &#xD;
            -  Presence or suspected presence of a visual impairment at the root of the motor skills&#xD;
               deficit.&#xD;
  &#xD;
            -  Presence or suspected presence of a neurological motor disorder (e.g. sensory&#xD;
               impairment, cerebral palsy, muscular dystrophy, degenerative disease).&#xD;
  &#xD;
            -  Not affiliated to a social security scheme or not benefiting from such a scheme.&#xD;
  &#xD;
            -  Absence of written, informed consent from parents.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>NESENSOHN Jessica</last_name>
      <phone>04 67 33 52 17</phone>
      <email>j-nesensohn@chu-montpellier.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hôpital La Colombière - CHU de Montpellier</name>
        <address>
          <city>Montpellier</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <reference>
      <citation>American Psychiatric Association (APA) (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.</citation>
    </reference>
    <reference>
      <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.</citation>
      <PMID>27443353</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>24139714</PMID>
    </reference>
    <reference>
      <citation>Expertise Collective INSERM (2019). Trouble développemental de la coordination ou dyspraxie, Paris : Les Editions EDP Sciences.</citation>
    </reference>
    <reference>
      <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.</citation>
      <PMID>22960066</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>: Developmental Coordination Disorder</keyword>
    <keyword>Rhythm</keyword>
    <keyword>Rhythmic skills</keyword>
    <keyword>Handwriting</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Motor Skills Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06006767
  org study id: RECHMPL23_0112
  nct id: NCT06006767
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Other
  time perspective: Other
  measure: The rhythm of handwriting movement
  time frame: 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).
  measure: The rhythmic variables
  time frame: 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
  time frame: 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.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 10 Years
  healthy volunteers: No
  last name: NESENSOHN Jessica
  phone: 04 67 33 52 17
  email: j-nesensohn@chu-montpellier.fr
  facility: 
  country: France
  citation: American Psychiatric Association (APA) (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
  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: 27443353
  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.
  PMID: 24139714
  citation: Expertise Collective INSERM (2019). Trouble développemental de la coordination ou dyspraxie, Paris : Les Editions EDP Sciences.
  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.
  PMID: 22960066
  responsible party type: Sponsor
  mesh term: Motor Skills Disorders