- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02231827
Balance Control During Gait (FREINAGE3D)
A Study of the Balance Control During Gait : Comparison of Data Acquisition Between Force Plate and 3D Optoelectronic Gait Analysis System
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rouen, France
- Rouen University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy subjects
- Between 20 and 40 years old
- Effective contraception for women of childbearing age
Exclusion Criteria:
- 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
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gait analysis
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Braking of the center of mass index during gait initiation
Time Frame: 1 day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Braking of the center of mass index during locomotion
Time Frame: 1 day
|
Braking of the center of mass (CM), a biomechanical parameter obtained from the vertical velocity of the CM, determined by a 3D optoelectronic gait analysis system (VICON).
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nathalie CHASTAN, MD, University Hospital, Rouen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/058/HP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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