NCT04891562

Brief Summary

This study is a case-controlled observational study, involving children with Developmental Coordination Disorder (DCD) and typically developing children with an age from 8 up to 12 years old. The study aims to investigate interlimb coordination of the lower limbs and sensorimotor synchronization ability in children with DCD compared to age-matched typically developing children during gait and fundamental lower limb coordination task to 2 metronomes with different temporal structures. The study consists of a maximum of 4 sessions (2 descriptive sessions, 2 experimental sessions), each lasting around 60 minutes. Depending on the preferences of the child and parents, the sessions can be combined in 2 sessions of 2 hours. During the first descriptive session, the participant will perform the m-ABC2 test to assess gross and fine motor function. The MBEMA-s will be used to examine rhythm perception ability. During the second descriptive session, children will perform the Kids BESTest to examine postural control, and two cognitive tests (digit span, go-no/go test) to assess executive functioning. During the third visit (experimental session), interlimb coordination and synchronization will be investigated during three tasks with different dynamic balance demands (seated, walking and running) in three conditions: in silence, to beats in isochronous metronome (discrete structure), to beats in non-isochronous metronomes (sinusoidal structure). In the last experimental session, the tempi of the auditory metronomes will be set at higher and lower tempi than the preferred comfortable tempo of the child.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

May 13, 2021

Last Update Submit

December 6, 2024

Conditions

Keywords

Developmental Coordination DisorderInterlimb coordinationGaitSensorimotor synchronizationMetronomes

Outcome Measures

Primary Outcomes (6)

  • Phase coordination index (PCI)

    PCI is a measurement of consistency and accuracy in generating a series of anti-phase left - right stepping phases. Detailed information is described in Plotnik et al. (2007). Shortly, phase represent the relative timing of contralateral heel strikes, determining the phase, and normalize the step time with respect to the stride time (Plotnik, Giladi, \& Hausdorff, 2007). Ideal interlimb coordination for each step is 180°. The consistency of the phase generation is represented by the Coefficient of variation of the series of the relative timing of the stepping of one leg with respect to the gait cycle.A lower PCI%, closer to zero, indicates a better antiphase interlimb coordination pattern.

    week 2

  • Phase coordination index (PCI)

    PCI is a measurement of consistency and accuracy in generating a series of anti-phase left - right stepping phases. Detailed information is described in Plotnik et al. (2007). Shortly, phase represent the relative timing of contralateral heel strikes, determining the phase, and normalize the step time with respect to the stride time (Plotnik, Giladi, \& Hausdorff, 2007). Ideal interlimb coordination for each step is 180°. The consistency of the phase generation is represented by the Coefficient of variation of the series of the relative timing of the stepping of one leg with respect to the gait cycle.A lower PCI%, closer to zero, indicates a better antiphase interlimb coordination pattern.

    week 3

  • Auditory motor coupling - Resultant Vector Length to quantify synchronization consistency

    Synchronization consistency of steps to the beats during walking and running; and of the knee flexion-extension movement to the beats during the seated task Resultant Vector Length to quantify synchronization consistency. If the distribution of the relative phase angles over time is consistent, it results in a high resultant vector length (maximum value 1). If the synchronization is not consistent, the resultant vector length will be low (minimum value 0)

    week 2

  • Auditory motor coupling - Resultant Vector Length to quantify synchronization consistency

    Synchronization consistency of steps to the beats during walking and running; and of the knee flexion-extension movement to the beats during the seated task Resultant Vector Length to quantify synchronization consistency. If the distribution of the relative phase angles over time is consistent, it results in a high resultant vector length (maximum value 1). If the synchronization is not consistent, the resultant vector length will be low (minimum value 0)

    week 3

  • Auditory motor coupling - Relative phase angle

    Synchronization accuracy of steps to the beats during walking and running; and of the knee flexion-extension movement to the beats during the seated task. Relative phase angle, asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

    week 2

  • Auditory motor coupling - Relative phase angle

    Synchronization accuracy of steps to the beats during walking and running; and of the knee flexion-extension movement to the beats during the seated task. Relative phase angle, asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

    week 3

Secondary Outcomes (19)

  • velocity (m/s)

    week 2

  • velocity (m/s)

    week 3

  • step width (cm)

    week 2

  • step width (cm)

    week 3

  • stride length (cm)

    week 2

  • +14 more secondary outcomes

Study Arms (2)

pDCD (hildren with (probably) Developmental Coordination Disorder)

EXPERIMENTAL

children with (probably) Developmental Coordination Disorder (pDCD)

Other: interlimb coordination of the lower limbs and synchronization

TDC (Typically Developing Children)

ACTIVE COMPARATOR

Typically Developing Children

Other: interlimb coordination of the lower limbs and synchronization

Interventions

4 sessions (2 descriptive sessions, 2 experimental sessions), each lasting around 60 minutes. The m-ABC2 test, The MBEMA-s, Kids BESTest, interlimb coordination and synchronization investigation (visit 3 and 4)

TDC (Typically Developing Children)pDCD (hildren with (probably) Developmental Coordination Disorder)

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • are aged between 8-12 years
  • have no medical conditions that could impede their motor abilities.
  • Children with a diagnosis of DCD, consistent with the DSM-V (Blank et al., 2019), or total percentile score \<P16 on the movement assessment battery for children edition 2 (m-ABC-2), will be included in the group of (probably) DCD.

You may not qualify if:

  • have other neurological, orthopaedical, cardiorespiratory or intellectual impairment that could affect their motor abilities (verified using a health questionnaire)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Eugene Rameckers, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR
  • Mieke Goetschalckx, drs.

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 18, 2021

Study Start

January 25, 2021

Primary Completion

January 18, 2023

Study Completion

January 18, 2023

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations