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Rhythmic Interlimb Coordination in Children With Developmental Coordination Disorder

Primary Purpose

Developmental Coordination Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
interlimb coordination of the lower limbs and synchronization
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Developmental Coordination Disorder focused on measuring Developmental Coordination Disorder, Interlimb coordination, Gait, Sensorimotor synchronization, Metronomes

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.
  • The m-ABC score total of typical developing children needs to be ≥P25 for inclusion

Exclusion Criteria:

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

Sites / Locations

  • Hasselt UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pDCD (hildren with (probably) Developmental Coordination Disorder)

TDC (Typically Developing Children)

Arm Description

children with (probably) Developmental Coordination Disorder (pDCD)

Typically Developing Children

Outcomes

Primary Outcome Measures

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.
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.
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)
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)
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)
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)

Secondary Outcome Measures

velocity (m/s)
Spatiotemporal parameters during the walking and running tasks: Gait velocity (m/s): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
velocity (m/s)
Spatiotemporal parameters during the walking and running tasks: Gait velocity (m/s): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
step width (cm)
Spatiotemporal parameters during the walking and running tasks: step width: absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
step width (cm)
Spatiotemporal parameters during the walking and running tasks: step width: absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
stride length (cm)
Spatiotemporal parameters during the walking and running tasks are: stride length (cm): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
stride length (cm)
Spatiotemporal parameters during the walking and running tasks are: stride length (cm): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
cadence (step/minute)
Spatiotemporal parameters during the walking and running tasks cadence (step/minute): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
cadence (step/minute)
Spatiotemporal parameters during the walking and running tasks cadence (step/minute): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
double support (%gait cycle)
Spatiotemporal parameters during the walking and running tasks: double support. Absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
double support (%gait cycle)
Spatiotemporal parameters during the walking and running tasks: double support. Absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
movement frequency
Spatiotemporal parameters during the seated antiphase knee flexion- extension task: movement frequency. The movement frequency of the leg movement signifies the temporal movement parameter, expressed as the amount of movement cycles in one minute. One movement cycle is defined between two successive peak extension positions. The average movement frequency of each leg, per metronome condition, will be calculated.
movement frequency
Spatiotemporal parameters during the seated antiphase knee flexion- extension task: movement frequency. The movement frequency of the leg movement signifies the temporal movement parameter, expressed as the amount of movement cycles in one minute. One movement cycle is defined between two successive peak extension positions. The average movement frequency of each leg, per metronome condition, will be calculated.
movement amplitude
Spatiotemporal parameters during the seated antiphase knee flexion- extension task: movement amplitude. The movement amplitude of the leg movement signifies the spatial movement parameter, for each individual movement cycle. The average amplitude of the movement cycles per metronome condition, for each leg separately, will be calculated.
movement amplitude
Spatiotemporal parameters during the seated antiphase knee flexion- extension task: movement amplitude. The movement amplitude of the leg movement signifies the spatial movement parameter, for each individual movement cycle. The average amplitude of the movement cycles per metronome condition, for each leg separately, will be calculated.
The m-ABC (second edition)
The m-ABC (second edition) is a test to assess gross (static and dynamic balance, aiming and catching) and fine motor functions (manual dexterity) in children aged between 3 and 16 years. The m-ABC-second edition is a norm referenced test. The raw score of each task will be converted to standard scores (mean standard score of 10, standard deviation of 3) and percentiles. A lower score indicates a lower motor functioning. A total test score percentile below percentile 16 is at risk for problems with motor functions.
Montreal Battery of Evaluation of Musical Abilities (MBEMA-s)
beat perception ability will be assessed using two components (rhythm and melody) of the short version of the Montreal Battery of Evaluation of Musical Abilities (MBEMA-s). A maximum score of 20 can be attained for each component (rhythm and melody). A higher score indicated a better beat perception ability.
Kids BESTest
Balance Evaluation Systems test for children" (Kids BESTest) includes six domains: biomechanical constraints (maximum score 15) , stability limits and verticality (maximum score 21), transitions/anticipatory (maximum score 18), Reactive(maximum score 18) , sensory orientation (maximum score 15), and stability in gait(maximum score 21) .For each task, a score of 0 indicates severe, where a score of 3 indicates normal performance. A higher score (total maximum score of 108) indicates a higher balance control.
digit span
The digit span (forwards and backwards will be used to describe working memory. Children will be asked to listen to the digit span, consisting of random digits ranging from 1 to 9, and repeat the digit span forwards or backwards. The maximum length of digits that can be obtained is 9 for the digit span forward and 8 for the digit span backward. A higher score indicates a better performance.
go-no/go test
The Go-no/Go task paradigm was developed to assess behavioral inhibition in children with limited working memory demands. Two versions of the Go-no/go test will be performed, namely an auditory and a visual.For both the auditory and visual task, a maximum score of 60 correct responses can be obtained. A lower score (minimum 0 correct) indicates a worse performance.

Full Information

First Posted
May 13, 2021
Last Updated
May 20, 2021
Sponsor
Hasselt University
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1. Study Identification

Unique Protocol Identification Number
NCT04891562
Brief Title
Rhythmic Interlimb Coordination in Children With Developmental Coordination Disorder
Official Title
Rhythmic Interlimb Coordination in Children With Developmental Coordination Disorder Compared to Typical Developing Children: the Effect of Individual, Task and Environmental Constraints
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder
Keywords
Developmental Coordination Disorder, Interlimb coordination, Gait, Sensorimotor synchronization, Metronomes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pDCD (hildren with (probably) Developmental Coordination Disorder)
Arm Type
Experimental
Arm Description
children with (probably) Developmental Coordination Disorder (pDCD)
Arm Title
TDC (Typically Developing Children)
Arm Type
Active Comparator
Arm Description
Typically Developing Children
Intervention Type
Other
Intervention Name(s)
interlimb coordination of the lower limbs and synchronization
Intervention Description
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)
Primary Outcome Measure Information:
Title
Phase coordination index (PCI)
Description
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.
Time Frame
week 2
Title
Phase coordination index (PCI)
Description
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.
Time Frame
week 3
Title
Auditory motor coupling - Resultant Vector Length to quantify synchronization consistency
Description
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)
Time Frame
week 2
Title
Auditory motor coupling - Resultant Vector Length to quantify synchronization consistency
Description
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)
Time Frame
week 3
Title
Auditory motor coupling - Relative phase angle
Description
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)
Time Frame
week 2
Title
Auditory motor coupling - Relative phase angle
Description
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)
Time Frame
week 3
Secondary Outcome Measure Information:
Title
velocity (m/s)
Description
Spatiotemporal parameters during the walking and running tasks: Gait velocity (m/s): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
Time Frame
week 2
Title
velocity (m/s)
Description
Spatiotemporal parameters during the walking and running tasks: Gait velocity (m/s): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
Time Frame
week 3
Title
step width (cm)
Description
Spatiotemporal parameters during the walking and running tasks: step width: absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
Time Frame
week 2
Title
step width (cm)
Description
Spatiotemporal parameters during the walking and running tasks: step width: absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
Time Frame
week 3
Title
stride length (cm)
Description
Spatiotemporal parameters during the walking and running tasks are: stride length (cm): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
Time Frame
week 2
Title
stride length (cm)
Description
Spatiotemporal parameters during the walking and running tasks are: stride length (cm): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
Time Frame
week 3
Title
cadence (step/minute)
Description
Spatiotemporal parameters during the walking and running tasks cadence (step/minute): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
Time Frame
week 2
Title
cadence (step/minute)
Description
Spatiotemporal parameters during the walking and running tasks cadence (step/minute): absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
Time Frame
week 3
Title
double support (%gait cycle)
Description
Spatiotemporal parameters during the walking and running tasks: double support. Absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
Time Frame
week 2
Title
double support (%gait cycle)
Description
Spatiotemporal parameters during the walking and running tasks: double support. Absolute values, variability (standard deviation) of spatiotemporal parameters and values normalized to leg length will be reported.
Time Frame
week 3
Title
movement frequency
Description
Spatiotemporal parameters during the seated antiphase knee flexion- extension task: movement frequency. The movement frequency of the leg movement signifies the temporal movement parameter, expressed as the amount of movement cycles in one minute. One movement cycle is defined between two successive peak extension positions. The average movement frequency of each leg, per metronome condition, will be calculated.
Time Frame
week 2
Title
movement frequency
Description
Spatiotemporal parameters during the seated antiphase knee flexion- extension task: movement frequency. The movement frequency of the leg movement signifies the temporal movement parameter, expressed as the amount of movement cycles in one minute. One movement cycle is defined between two successive peak extension positions. The average movement frequency of each leg, per metronome condition, will be calculated.
Time Frame
week 3
Title
movement amplitude
Description
Spatiotemporal parameters during the seated antiphase knee flexion- extension task: movement amplitude. The movement amplitude of the leg movement signifies the spatial movement parameter, for each individual movement cycle. The average amplitude of the movement cycles per metronome condition, for each leg separately, will be calculated.
Time Frame
week 2
Title
movement amplitude
Description
Spatiotemporal parameters during the seated antiphase knee flexion- extension task: movement amplitude. The movement amplitude of the leg movement signifies the spatial movement parameter, for each individual movement cycle. The average amplitude of the movement cycles per metronome condition, for each leg separately, will be calculated.
Time Frame
week 3
Title
The m-ABC (second edition)
Description
The m-ABC (second edition) is a test to assess gross (static and dynamic balance, aiming and catching) and fine motor functions (manual dexterity) in children aged between 3 and 16 years. The m-ABC-second edition is a norm referenced test. The raw score of each task will be converted to standard scores (mean standard score of 10, standard deviation of 3) and percentiles. A lower score indicates a lower motor functioning. A total test score percentile below percentile 16 is at risk for problems with motor functions.
Time Frame
Baseline
Title
Montreal Battery of Evaluation of Musical Abilities (MBEMA-s)
Description
beat perception ability will be assessed using two components (rhythm and melody) of the short version of the Montreal Battery of Evaluation of Musical Abilities (MBEMA-s). A maximum score of 20 can be attained for each component (rhythm and melody). A higher score indicated a better beat perception ability.
Time Frame
Baseline
Title
Kids BESTest
Description
Balance Evaluation Systems test for children" (Kids BESTest) includes six domains: biomechanical constraints (maximum score 15) , stability limits and verticality (maximum score 21), transitions/anticipatory (maximum score 18), Reactive(maximum score 18) , sensory orientation (maximum score 15), and stability in gait(maximum score 21) .For each task, a score of 0 indicates severe, where a score of 3 indicates normal performance. A higher score (total maximum score of 108) indicates a higher balance control.
Time Frame
week 1
Title
digit span
Description
The digit span (forwards and backwards will be used to describe working memory. Children will be asked to listen to the digit span, consisting of random digits ranging from 1 to 9, and repeat the digit span forwards or backwards. The maximum length of digits that can be obtained is 9 for the digit span forward and 8 for the digit span backward. A higher score indicates a better performance.
Time Frame
week 1
Title
go-no/go test
Description
The Go-no/Go task paradigm was developed to assess behavioral inhibition in children with limited working memory demands. Two versions of the Go-no/go test will be performed, namely an auditory and a visual.For both the auditory and visual task, a maximum score of 60 correct responses can be obtained. A lower score (minimum 0 correct) indicates a worse performance.
Time Frame
week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. The m-ABC score total of typical developing children needs to be ≥P25 for inclusion Exclusion Criteria: • have other neurological, orthopaedical, cardiorespiratory or intellectual impairment that could affect their motor abilities (verified using a health questionnaire)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eugene Rameckers, prof. dr.
Phone
+32 11 26 89 91
Email
eugene.rameckers@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Mieke Goetschalckx, drs.
Phone
+32 11 89 91
Email
mieke.goetschalckx@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Rameckers, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mieke Goetschalckx, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mieke Goetschalckx, drs.
Phone
+32 11 26 89 81
Email
mieke.goetschalckx@uhasselt.be

12. IPD Sharing Statement

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Rhythmic Interlimb Coordination in Children With Developmental Coordination Disorder

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