Normative Database for Gait Analysis on the GRAIL UZ Gent

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gait
• Intervention / Treatment: Other: Walking on an instrumented treadmill; Other: Walking on an instrumented treadmill while dual-tasking

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anke Van Bladel, PhD; Phone Number: 093321243; Email: Anke.VanBladel@UGent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Anke Van Bladel; Email: anke.vanbladel@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.

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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	Gender, age	single point assessment in 1 day
height (cm)	anthropometric data	single point assessment in 1 day
weight	anthropometric data	single point assessment in 1 day
segment lengths (cm)	anthropometric data	single point assessment in 1 day
M-ABC-2	Standardized tool to indentify motor functioning in children	single point assessment in 1 day
Developmental Coordination Disorder Questionnaire (DCDQ)	Brief parent questionnaire to screen for coordination disorders in children	single point assessment in 1 day

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Healthy; EMG; Gait analysis; Kinematics; Kinetics; Dual-tasking; Control group; Reference data
• Other Study ID Numbers: B670201942108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No