Developmental Coordination DisorderNCT04891562
Rhythmic Interlimb Coordination in Children with Developmental Coordination Disorder
A study testing interlimb coordination of the lower limbs and synchronization in people with Developmental Coordination Disorder, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- interlimb coordination of the lower limbs and synchronization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jan 2021to 18 Jan 2023
- Phase
- Interventional
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- have other neurological, orthopaedical, cardiorespiratory or intellectual impairment that could affect their motor abilities (verified using a health questionnaire)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rhythmic Interlimb Coordination in Children with Developmental Coordination Disorder Compared to Typical Developing Children: the Effect of Individual, Task and Environmental Constraints
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.
- Conditions
- Developmental Coordination Disorder
- Being tested
- interlimb coordination of the lower limbs and synchronization
- Keywords
- Developmental Coordination Disorder, Interlimb coordination, Gait, Sensorimotor synchronization, Metronomes
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interlimb coordination of the lower limbs and synchronizationOther
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)
| Study group | Role | What they receive |
|---|---|---|
| pDCD (hildren with (probably) Developmental Coordination Disorder) | Experimental | children with (probably) Developmental Coordination Disorder (pDCD) Receives: Other: interlimb coordination of the lower limbs and synchronization |
| TDC (Typically Developing Children) | Active comparator | Typically Developing Children Receives: Other: interlimb coordination of the lower limbs and synchronization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: week 3
Secondary outcomes (19)
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.
Measured: week 2
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.
Measured: week 3
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.
Measured: week 2
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.
Measured: week 3
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.
Measured: week 2
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.
Measured: week 3
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.
Measured: week 2
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.
Measured: week 3
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.
Measured: week 2
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.
Measured: week 3
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.
Measured: week 2
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.
Measured: week 3
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.
Measured: week 2
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.
Measured: week 3
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: week 1
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.
Measured: week 1
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.
Measured: week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start25 Jan 2021
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugene Rameckers, Hasselt University
- Investigators
- Eugene Rameckers, prof. dr., Principal investigator, Hasselt UniversityMieke Goetschalckx, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891562
- Sponsor's protocol ID
- RIC-CHILD-001
- Status last verified
- Dec 2024
- First submitted
- 13 May 2021
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythmic Interlimb Coordination in Children with Developmental Coordination Disorder Compared to Typical Developing Children: the Effect of Individual, Task and Environmental Constraints
- ClinicalTrials.gov ID
- NCT04891562
- Acronym / sponsor ID
- RIC-CHILD-001
- Conditions
- Developmental Coordination Disorder
- Keywords
- Developmental Coordination Disorder, Interlimb coordination, Gait, Sensorimotor synchronization, Metronomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 18 May 2021 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pDCD (hildren with (probably) Developmental Coordination Disorder) | Experimental | Other: interlimb coordination of the lower limbs and synchronizationchildren with (probably) Developmental Coordination Disorder (pDCD) |
| TDC (Typically Developing Children) | Active comparator | Other: interlimb coordination of the lower limbs and synchronizationTypically Developing Children |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- have other neurological, orthopaedical, cardiorespiratory or intellectual impairment that could affect their motor abilities (verified using a health questionnaire)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interlimb coordination of the lower limbs and synchronization4 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) | Other | TDC (Typically Developing Children), pDCD (hildren with (probably) Developmental Coordination Disorder) |
Primary outcome
Phase coordination index (PCI)
Time frame: week 2
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)
Time frame: week 3
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
Time frame: week 2
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
Time frame: week 3
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
Time frame: week 2
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
Time frame: week 3
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)
19 secondary outcomes
velocity (m/s)
Time frame: week 2
velocity (m/s)
Time frame: week 3
step width (cm)
Time frame: week 2
step width (cm)
Time frame: week 3
stride length (cm)
Time frame: week 2
stride length (cm)
Time frame: week 3
cadence (step/minute)
Time frame: week 2
cadence (step/minute)
Time frame: week 3
double support (%gait cycle)
Time frame: week 2
double support (%gait cycle)
Time frame: week 3
movement frequency
Time frame: week 2
movement frequency
Time frame: week 3
movement amplitude
Time frame: week 2
movement amplitude
Time frame: week 3
The m-ABC (second edition)
Time frame: Baseline
Montreal Battery of Evaluation of Musical Abilities (MBEMA-s)
Time frame: Baseline
Kids BESTest
Time frame: week 1
digit span
Time frame: week 1
go-no/go test
Time frame: week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Eugene Rameckers, prof. dr. principal investigator
Hasselt University
Mieke Goetschalckx, drs. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interlimb coordination of the lower limbs and synchronization in people with Developmental Coordination Disorder, run by Hasselt University at 1 site in Belgium.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 11 Dec 2024. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase coordination index (PCI) (time frame: week 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.