NCT02231827

Brief Summary

Gait and balance disorders are important public health problem necessitating studies to try to prevent falls. Many studies have dealt with spatiotemporal gait parameters or balance during quiet standing (posturography). Nevertheless, falls occurred predominantly during gait, and rarely during quiet standing. We have developed a tool to measure balance during gait : the braking of the center of mass (CM), a biomechanical parameter obtained from the vertical velocity of the CM recorded with a force plate. In previous studies, we have shown that the braking of the CM was a physiological and a active mechanism, reflecting balance during gait. Unfortunately, the braking of the CM measured on a force plate provide an important intra-individual variability. The 3D optoelectronic gait analysis system (VICON) also provide an estimation of the CM. The primary goal of this study is to compare intra-individual variability of the braking of the CM determined by a force plate or the 3D optoelectronic gait analysis system (VICON) in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 11, 2026

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

September 1, 2014

Last Update Submit

May 5, 2026

Conditions

Healthy

Keywords

subjects

Outcome Measures

Primary Outcomes (1)

  • Braking of the center of mass index during gait initiation

    Braking of the center of mass (CM), a biomechanical parameter obtained from the vertical velocity of the CM, determined by a force plate or a 3D optoelectronic gait analysis system (VICON).

    1 day

Secondary Outcomes (1)

  • Braking of the center of mass index during locomotion

    1 day

Study Arms (1)

Gait analysis

EXPERIMENTAL
Other: Gait analysis

Interventions

Gait analysisOTHER

Subjects, barefoot and standing upright and motionless on a force plate, were instructed to walk for 10 m following a beep delivered by the experimenter. Two experimental conditions were tested: (i) the 'natural' gait condition where subjects walked normally and (ii) the 'fast' gait condition where subjects walked as fast as they could, taking large steps. Each subject performed 10 trials in each condition.

Also known as: - Force plate, - 3D optoelectronic gait analysis system (VICON)
Gait analysis

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • Between 20 and 40 years old
  • Effective contraception for women of childbearing age

You may not qualify if:

  • Neurological, vestibular, rheumatologic, orthopaedic disorders, which could influence gait and balance.
  • Known spinal deformity
  • Severe visual impairment : visual acuity less than 6/10
  • Inability to stand and walk without assistance 15 meters
  • Subjects without social security
  • Subjects involved in another biomedical trial during this study
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Related Publications (1)

  • Langeard A, Mathon C, Ould-Slimane M, Decker L, Bessot N, Gauthier A, Chastan N. Kinematics or Kinetics: Optimum Measurement of the Vertical Variations of the Center of Mass during Gait Initiation. Sensors (Basel). 2021 Nov 29;21(23):7954. doi: 10.3390/s21237954.

    PMID: 34883958RESULT

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Nathalie CHASTAN, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

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

September 1, 2014

First Posted

September 4, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 11, 2026

Record last verified: 2015-09

Locations

FR(1)