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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06400043
Other study ID # ONZ-2023-0650
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date August 31, 2026

Study information

Verified date May 2024
Source University Ghent
Contact Michelle Verhoeven
Phone +32 9 332 46 57
Email michelle.verhoeven@ugent.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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..


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 23
Est. completion date August 31, 2026
Est. primary completion date August 31, 2025
Accepts healthy volunteers No
Gender All
Age group 7 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Cognitive dual-task
Participants will be asked to walk at comfortable walking speed while playing an additional cognitive task, namely the Stroop Color and Word Test.
Motor dual-task
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.

Locations

Country Name City State
Belgium Ghent University Ghent

Sponsors (2)

Lead Sponsor Collaborator
University Ghent University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Demographic data Gender, age Single point baseline assessment
Other Anthropometric data (height) Height and segment lengths (cm) Single point baseline assessment
Other Anthropometric data (weight) Weight (kg) Single point baseline assessment
Other M-ABC-2 Standardized tool to identify motor functioning in children (standard score between 1 and 19)
Standard scores indicate:
Significant motor difficulty: standard score < 6
Minor motor difficulties: standard score 6 or 7
No motor difficulty: standard score > 7
Single point baseline assessment
Other Developmental Coordination Disorder Questionnaire (DCDQ) Brief parent questionnaire to screen for coordination disorders in children (total score between 15-75)
Children score suspected/an indication for DCD when:
Age 5-7: score of <47
Age 8-9: score of <56
Age 10-15: score of <58
Single point baseline assessment
Primary Kinematics 3D kinematics of lower and upper limb joints while walking (degrees) Single point assessment, day 1
Primary Kinetics 3D kinetics of lower limb joints while walking (Nm) Single point assessment, day 1
Primary EMG Muscle activity of 16 lower limb muscles (microvolts) Single point assessment, day 1
Primary Muscle synergies Synergy analysis will be conducted using the EMG data (variance accounted for -VAF) Single point assessment, day 1
Primary Spatiotemporal parameters Spatial parameters (m), temporal parameters (s), walking velocity (m/s) Single point assessment, day 1
Secondary Gait deviation index Based on kinematics, the lower-limb gait deviations will be calculated (degrees) Single point assessment, day 1
Secondary Game result (cognitive task) Score (% correct) Single point assessment, day 1
Secondary Game result (motor task) Score (% correct) Single point assessment, day 1
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