HealthyFREINAGE3DNCT02231827
Balance Control During Gait
A study testing Gait analysis in people with Healthy, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gait analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Between 20 and 40 years old
- Effective contraception for women of childbearing age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Gait analysis
- Keywords
- subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisOther
Also called - Force plate, - 3D optoelectronic gait analysis system (VICON)
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.
| Study group | Role | What they receive |
|---|---|---|
| Gait analysis | Experimental | Not described Receives: Other: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (1)
Braking of the center of mass index during locomotion
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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie CHASTAN, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231827
- Sponsor's protocol ID
- 2014/058/HP
- Acronym
- FREINAGE3D
- Status last verified
- Sep 2015
- First submitted
- 1 Sep 2014
- Last updated
- 11 May 2026
- Results posted
- No
Publications
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.
PubMed 34883958
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Balance Control During Gait : Comparison of Data Acquisition Between Force Plate and 3D Optoelectronic Gait Analysis System
- ClinicalTrials.gov ID
- NCT02231827
- Acronym / sponsor ID
- FREINAGE3D / 2014/058/HP
- Conditions
- Healthy
- Keywords
- subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait analysis | Experimental | Other: Gait analysis |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects
- Between 20 and 40 years old
- Effective contraception for women of childbearing age
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait analysisAlso: - Force plate, - 3D optoelectronic gait analysis system (VICON)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 | Gait analysis |
Primary outcome
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 secondary outcome
Braking of the center of mass index during locomotion
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Results publication: PubMed 34883958Langeard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie CHASTAN, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis in people with Healthy, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Braking of the center of mass index during gait initiation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02231827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.