NCT06400043

Brief 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..

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jul 2024Aug 2026

First Submitted

Initial submission to the registry

May 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 12, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

May 1, 2024

Last Update Submit

March 19, 2026

Conditions

Keywords

Gait analysisDual-taskingEMGKinematicsKineticsSelective motor controlDevelopmental Coordination DisorderDCD

Outcome Measures

Primary Outcomes (5)

  • Kinematics

    3D kinematics of lower and upper limb joints while walking (degrees)

    Single point assessment, day 1

  • Kinetics

    3D kinetics of lower limb joints while walking (Nm)

    Single point assessment, day 1

  • EMG

    Muscle activity of 16 lower limb muscles (microvolts)

    Single point assessment, day 1

  • Muscle synergies

    Synergy analysis will be conducted using the EMG data (variance accounted for -VAF)

    Single point assessment, day 1

  • Spatiotemporal parameters

    Spatial parameters (m), temporal parameters (s), walking velocity (m/s)

    Single point assessment, day 1

Secondary Outcomes (3)

  • Gait deviation index

    Single point assessment, day 1

  • Game result (cognitive task)

    Single point assessment, day 1

  • Game result (motor task)

    Single point assessment, day 1

Other Outcomes (5)

  • Demographic data

    Single point baseline assessment

  • Anthropometric data (height)

    Single point baseline assessment

  • Anthropometric data (weight)

    Single point baseline assessment

  • +2 more other outcomes

Study Arms (1)

Treadmill walking

EXPERIMENTAL

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.

Other: Cognitive dual-taskOther: Motor dual-task

Interventions

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

Treadmill walking

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.

Treadmill walking

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Ghent University

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Lynn Bar-On

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 6, 2024

Study Start

July 12, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations