Normative Database for Gait Analysis on the GRAIL UZ Gent

Gait Clinical Trial

Official title:

Normative Database for Gait Analyses and Balance on the GRAIL at the University Hospital of Ghent.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987346
• Other study ID #: B670201942108
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2021
• Est. completion date: January 1, 2026

Study information

• Verified date: November 2023
• Source: University Hospital, Ghent
• Contact: Anke Van Bladel, PhD
• Phone: 093321243
• Email: Anke.VanBladel[@]UGent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to collect a large set of norm/control data on an instrumented treadmill (the Gait Real-time Analysis Interactive Lab - GRAIL) at the university hospital of Ghent for the purpose of clinical studies as well as for clinical interpretation.

We hypothesize that this norm/control data will provide reference data of the normal gait patterns in the healthy population such that we can then use it to identify gait abnormalities in populations with pathology.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy participants

Exclusion Criteria:

• They suffer from neurological disorder

• Have balance problems

• 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 test taking.

Related Conditions & MeSH terms

• Gait

Intervention

Other:
• Walking on an instrumented treadmill
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.
• Walking on an instrumented treadmill while dual-tasking
Participants aged between 6 and 17 years will be asked to walk at comfortable walking speed while playing either a cognitive (Stroop Color and Word Test) or motor (requiring arm swing) game.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic data	Gender, age	single point assessment in 1 day
Other	height (cm)	anthropometric data	single point assessment in 1 day
Other	weight	anthropometric data	single point assessment in 1 day
Other	segment lengths (cm)	anthropometric data	single point assessment in 1 day
Other	M-ABC-2	Standardized tool to indentify motor functioning in children	single point assessment in 1 day
Other	Developmental Coordination Disorder Questionnaire (DCDQ)	Brief parent questionnaire to screen for coordination disorders in children	single point assessment in 1 day
Primary	Kinematics	3D kinematics of lower and upper limb joints while walking (degrees)	single point assessment in 1 day
Primary	Kinetics	3D kinetics of lower limb joints while walking (Nm)	single point assessment in 1 day
Primary	EMG	Muscle activity of 32 lower and upper limb muscles (micorvolts)	single point assessment in 1 day
Primary	EMG synergies	Synergy analysis will be carried using the EMG data (variance accounted for -VAF)	single point assessment in 1 day
Primary	Spatiotemporal parameters	Spatial parameters (m)	single point assessment in 1 day
Primary	Spatiotemporal parameters	Temporal parameters (s)	single point assessment in 1 day
Primary	Spatiotemporal parameters	Walking velocity (m/s)	single point assessment in 1 day
Secondary	Gait deviation index	Based on kinematics, the lower-limb gait deviations will be calculated (degrees)	single point assessment in 1 day
Secondary	Game result (cognitive task)	Score (% correct)	single point assessment in 1 day
Secondary	Game result (motor task)	Score (% correct)	single point assessment in 1 day