- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04891562
Rhythmic Interlimb Coordination in Children with Developmental Coordination Disorder
Rhythmic Interlimb Coordination in Children with Developmental Coordination Disorder Compared to Typical Developing Children: the Effect of Individual, Task and Environmental Constraints
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hasselt, Belgium, 3500
- Hasselt University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: pDCD (hildren with (probably) Developmental Coordination Disorder)
children with (probably) Developmental Coordination Disorder (pDCD)
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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)
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Active Comparator: TDC (Typically Developing Children)
Typically Developing Children
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Phase coordination index (PCI)
Time Frame: week 2
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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.
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week 2
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Phase coordination index (PCI)
Time Frame: week 3
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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
|
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Auditory motor coupling - Resultant Vector Length to quantify synchronization consistency
Time Frame: week 2
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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
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Auditory motor coupling - Resultant Vector Length to quantify synchronization consistency
Time Frame: week 3
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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
|
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Auditory motor coupling - Relative phase angle
Time Frame: week 2
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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)
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week 2
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Auditory motor coupling - Relative phase angle
Time Frame: week 3
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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velocity (m/s)
Time Frame: week 2
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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. |
week 2
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velocity (m/s)
Time Frame: week 3
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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. |
week 3
|
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step width (cm)
Time Frame: week 2
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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. |
week 2
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step width (cm)
Time Frame: week 3
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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. |
week 3
|
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stride length (cm)
Time Frame: week 2
|
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.
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week 2
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stride length (cm)
Time Frame: week 3
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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.
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week 3
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cadence (step/minute)
Time Frame: week 2
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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.
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week 2
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cadence (step/minute)
Time Frame: week 3
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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.
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week 3
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double support (%gait cycle)
Time Frame: week 2
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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. |
week 2
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double support (%gait cycle)
Time Frame: week 3
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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. |
week 3
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movement frequency
Time Frame: week 2
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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.
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week 2
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movement frequency
Time Frame: week 3
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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.
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week 3
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movement amplitude
Time Frame: week 2
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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.
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week 2
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movement amplitude
Time Frame: week 3
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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.
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week 3
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The m-ABC (second edition)
Time Frame: Baseline
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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.
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Baseline
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Montreal Battery of Evaluation of Musical Abilities (MBEMA-s)
Time Frame: Baseline
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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.
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Baseline
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Kids BESTest
Time Frame: week 1
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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.
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week 1
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digit span
Time Frame: week 1
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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.
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week 1
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go-no/go test
Time Frame: week 1
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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.
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week 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eugene Rameckers, prof. dr., Hasselt University
- Study Chair: Mieke Goetschalckx, drs., Hasselt University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIC-CHILD-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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