- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06400043
Dual-tasking Effect on Gait in Children With Developmental Coordination Disorder
The Influence of an Interceptive Task on Gait in Children With Developmental Coordination Disorder Compared to Typically Developing Children
The aim of the study is to collect data in children with developmental coordination disorder (DCD) aged between 7 and 17 years for analyses of the gait pattern while walking at the Gait Real-time Analysis Interactive Lab (GRAIL) at the university hospital of Ghent.
Children with DCD will be asked to take a motor test (M-ABC-2) as well as walk on the treadmill during a single session of approximately 3 hours.
The following data will be collected on the GRAIL while subjects walk at different gait speeds: 3D kinematics, kinetics, and EMG.
Additionally, 3D kinematics, kinetics, and EMG data will be collected when performing either a cognitive (Stroop Color and Word Test) or motor (requiring arm swing) dual-task while walking at comfortable walking speed..
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of the study is to collect data in children with developmental coordination disorder (DCD) aged between 7 and 17 years for analyses of the gait pattern while walking at the Gait Real-time Analysis Interactive Lab (GRAIL). This is a treadmill linked to a virtual environment used to analyse and train gait at the Children's Rehabilitation Centre of Ghent University Hospital. The data from children with DCD will be compared with typically developing children. In this study, only children with DCD will be included and the data resulting from this study will be compared to the data from the previous study in typically developing children (ID: B670201942108).
Children with DCD will be asked to take a motor test (M-ABC-2) as well as walk on the treadmill during a single session of approximately 3 hours. While walking at comfortable walking speed, two short games will be played i.e. dual-tasking. This involves both a cognitive (Stroop Colour-Word Test) and a motor (requires the use of the arms) dual task projected in the virtual environment of the GRAIL. The cognitive and motor task will be performed both while standing still (single tasking: ST) and while walking (dual tasking: DT). Simultaneously, kinetics, kinematics, and EMG data will be collected for 3D gait analysis. Using muscle synergy analysis (based on EMG data), the degree of gait automatization will be analysed. The data from children with DCD will be compared with typically developing children to determine whether a reduced gait automatization can be observed in children with DCD.
Parents will be asked to complete a screening list (CVO/DCD-Q) for motor problems in daily life. This aims as a support to the motor test (M-ABC-2), together providing additional insight into children's motor functioning (in daily life).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michelle Verhoeven
- Phone Number: +32 9 332 46 57
- Email: michelle.verhoeven@ugent.be
Study Locations
-
-
-
Ghent, Belgium, 9000
- Recruiting
- Ghent University
-
Contact:
- Lynn Bar-On, Prof.
- Email: Lynn.BarOn@ugent.be
-
-
East-Flanders
-
Ghent, East-Flanders, Belgium, 9000
- Recruiting
- Ghent University
-
Contact:
- Lynn Bar-On, Prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- They have an official DCD diagnosis;
- Are aged between 7 and 17 years old;
- Can walk at least 15 minutes consecutively;
- Have good or corrected vision.
Exclusion Criteria:
- They suffer from a neurological disorder;
- Take medications that affect gait and balance;
- Have undergone surgical procedures on the lower limbs in the past;
- Experience pain in their lower limbs or back at the time of testing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treadmill walking
Participants will be asked to walk at different gait velocities for 1 minute.
The treadmill speed will be increased incrementally at 0.1m/s intervals until just before running.
The comfortable walking speed will be determined.
|
Participants will be asked to walk at comfortable walking speed while playing an additional cognitive task, namely the Stroop Color and Word Test.
Participants will be asked to walk at comfortable walking speed while playing an additional motor task, namely a game that requires arm swing to hit the targets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinematics
Time Frame: Single point assessment, day 1
|
3D kinematics of lower and upper limb joints while walking (degrees)
|
Single point assessment, day 1
|
|
Kinetics
Time Frame: Single point assessment, day 1
|
3D kinetics of lower limb joints while walking (Nm)
|
Single point assessment, day 1
|
|
EMG
Time Frame: Single point assessment, day 1
|
Muscle activity of 16 lower limb muscles (microvolts)
|
Single point assessment, day 1
|
|
Muscle synergies
Time Frame: Single point assessment, day 1
|
Synergy analysis will be conducted using the EMG data (variance accounted for -VAF)
|
Single point assessment, day 1
|
|
Spatiotemporal parameters
Time Frame: Single point assessment, day 1
|
Spatial parameters (m), temporal parameters (s), walking velocity (m/s)
|
Single point assessment, day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait deviation index
Time Frame: Single point assessment, day 1
|
Based on kinematics, the lower-limb gait deviations will be calculated (degrees)
|
Single point assessment, day 1
|
|
Game result (cognitive task)
Time Frame: Single point assessment, day 1
|
Score (% correct)
|
Single point assessment, day 1
|
|
Game result (motor task)
Time Frame: Single point assessment, day 1
|
Score (% correct)
|
Single point assessment, day 1
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic data
Time Frame: Single point baseline assessment
|
Gender, age
|
Single point baseline assessment
|
|
Anthropometric data (height)
Time Frame: Single point baseline assessment
|
Height and segment lengths (cm)
|
Single point baseline assessment
|
|
Anthropometric data (weight)
Time Frame: Single point baseline assessment
|
Weight (kg)
|
Single point baseline assessment
|
|
M-ABC-2
Time Frame: Single point baseline assessment
|
Standardized tool to identify motor functioning in children (standard score between 1 and 19) Standard scores indicate:
|
Single point baseline assessment
|
|
Developmental Coordination Disorder Questionnaire (DCDQ)
Time Frame: Single point baseline assessment
|
Brief parent questionnaire to screen for coordination disorders in children (total score between 15-75) Children score suspected/an indication for DCD when:
|
Single point baseline assessment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lynn Bar-On, University Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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
- ONZ-2023-0650
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
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.
Clinical Trials on Gait
-
Centre Mutualiste de Rééducation et de Réadaptation...CompletedHealthy Volunteers | Gait | Child Development | Normal Gait | Normal Gait in Children | Pediatric Normative Gait DataFrance
-
Northumbria UniversityDANU Sports LtdRecruitingGait | Running | Walking | Gait AnalysisUnited Kingdom
-
Charles LinJewish Healthcare FoundationTerminated
-
Istanbul University - CerrahpasaCompletedGait Analysis | 3D Gait AnalysisTurkey
-
Peking University Third HospitalNot yet recruiting
-
University Hospital, GhentUniversity GhentRecruiting
-
University of NebraskaWithdrawn
-
University of PittsburghNational Institute on Aging (NIA)Completed
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingEMG | Running Kinematics | Biomechanical Changes | Gait Biomechanics | Gait Analysis in Healthy SubjectsTurkey (Türkiye)
-
Guangzhou General Hospital of Guangzhou Military...The First Affiliated Hospital of Guangzhou Medical University; Medical Center...Completed
Clinical Trials on Cognitive dual-task
-
Istanbul University - CerrahpasaNot yet recruiting
-
Chang Gung UniversityCompletedStroke | Healthy Older AdultsTaiwan
-
Fenerbahce UniversityRecruitingParkinson DiseaseTurkey
-
Foundation University IslamabadCompletedMild Cognitive Impairment | ElderlyPakistan
-
George Washington UniversityTerminated
-
Riphah International UniversityCompletedIntellectual DisabilityPakistan
-
University of PlymouthRecruiting
-
Riphah International UniversityActive, not recruiting
-
University of NebraskaNational Institute of General Medical Sciences (NIGMS)TerminatedParkinson Disease | Healthy AgingUnited States
-
Sahmyook UniversityCompletedForward Head Posture | Normal Head PostureSouth Korea