NCT04987346

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

July 14, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

4.5 years

First QC Date

July 5, 2021

Last Update Submit

November 6, 2023

Conditions

Gait

Keywords

Gait analysisControl groupHealthyReference dataKinematicsKineticsEMGDual-tasking

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • Gait deviation index

    single point assessment in 1 day

  • Game result (cognitive task)

    single point assessment in 1 day

  • Game result (motor task)

    single point assessment in 1 day

Other Outcomes (6)

  • Demographic data

    single point assessment in 1 day

  • height (cm)

    single point assessment in 1 day

  • weight

    single point assessment in 1 day

  • +3 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.

Other: Walking on an instrumented treadmillOther: Walking on an instrumented treadmill while dual-tasking

Interventions

Walking on an instrumented treadmillOTHER

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 while dual-taskingOTHER

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.

Treadmill walking

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Healthy participants

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

Central Study Contacts

Anke Van Bladel, PhD

CONTACT

093321243Anke.VanBladel@UGent.be

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

July 5, 2021

First Posted

August 3, 2021

Study Start

July 14, 2021

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)