Normative Database for Gait Analysis on the GRAIL UZ Gent

Not Applicable

Recruiting

• Conditions: Gait
• Interventions: Other: Walking on an instrumented treadmill; Other: Walking on an instrumented treadmill while dual-tasking

• Registration Number: NCT04987346
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-05
• Study Start: 2021-07-14
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-09
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treadmill walking	Walking on an instrumented treadmill while dual-tasking	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.
Treadmill walking	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.

Primary Outcome Measures

Name	Time	Method
Kinetics	single point assessment in 1 day	3D kinetics of lower limb joints while walking (Nm)
EMG	single point assessment in 1 day	Muscle activity of 32 lower and upper limb muscles (micorvolts)
EMG synergies	single point assessment in 1 day	Synergy analysis will be carried using the EMG data (variance accounted for -VAF)
Spatiotemporal parameters	single point assessment in 1 day	Walking velocity (m/s)
Kinematics	single point assessment in 1 day	3D kinematics of lower and upper limb joints while walking (degrees)

Secondary Outcome Measures

Name	Time	Method
Gait deviation index	single point assessment in 1 day	Based on kinematics, the lower-limb gait deviations will be calculated (degrees)
Game result (motor task)	single point assessment in 1 day	Score (% correct)
Game result (cognitive task)	single point assessment in 1 day	Score (% correct)

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium