Developmental Coordination DisorderTDC-RythmeNCT06006767
Rhythmic Handwriting Deficits and General Rhythmic Abilities in Children
An observational study of Developmental Coordination Disorder, run by University Hospital, Montpellier at 1 site in France.
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 \&… Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Developmental Coordination Disorder
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2023to 17 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: DCD children
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Links Between Rhythmic Handwriting Deficits and General Rhythmic Abilities in Children With Developmental Coordination Disorder: a Pilot Study. TDC-Rythme
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.
- Conditions
- Developmental Coordination Disorder
- Keywords
- : Developmental Coordination Disorder, Rhythm, Rhythmic skills, Handwriting
- Medical subject headings
- Motor Skills Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day at First visit
Secondary outcomes (2)
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).
Measured: 1 day at First visit
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.
Measured: 1 day at First visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start16 Oct 2023 (estimated)
- Primary completion16 Jul 2025 (estimated)
- Study completion17 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006767
- Sponsor's protocol ID
- RECHMPL23_0112
- Acronym
- TDC-Rythme
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27443353Danna 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.
PubMed 24139714Expertise 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.
PubMed 22960066
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Links Between Rhythmic Handwriting Deficits and General Rhythmic Abilities in Children With Developmental Coordination Disorder: a Pilot Study. TDC-Rythme
- ClinicalTrials.gov ID
- NCT06006767
- Acronym / sponsor ID
- TDC-Rythme / RECHMPL23_0112
- Conditions
- Developmental Coordination Disorder
- Keywords
- : Developmental Coordination Disorder, Rhythm, Rhythmic skills, Handwriting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Oct 2023 (estimated)
- Primary completion
- 16 Jul 2025 (estimated)
- Study completion
- 17 Jan 2026 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- DCD children
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rhythm of handwriting movement
Time frame: 1 day at First visit
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).
2 secondary outcomes
The rhythmic variables
Time frame: 1 day at First visit
Speed of handwriting : abnormal peak velocity fluctuations during handwriting movement
Time frame: 1 day at First visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- BackgroundAmerican Psychiatric Association (APA) (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
- Background: PubMed 27443353Dalla 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.
- Background: PubMed 24139714Danna 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.
- BackgroundExpertise Collective INSERM (2019). Trouble développemental de la coordination ou dyspraxie, Paris : Les Editions EDP Sciences.
- Background: PubMed 22960066Rosenblum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Coordination Disorder, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NESENSOHN Jessica (04 67 33 52 17, j-nesensohn@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rhythm of handwriting movement (time frame: 1 day at First visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06006767, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.