Persons Who Have Experienced a Sudden Uncontrolled Fall in the Absence of Outside Factors in the 6 Months Preceding the ConsultationNCT03343769
Study of the Relationship Between the Strength of Ankle Movement Muscles and Postural Parameters in Elderly Fallers: Towards New Strategies for Screening and Management
An observational study of Persons Who Have Experienced a Sudden Uncontrolled Fall in the Absence of Outside Factors in the 6 Months Preceding the Consultation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The quality of life of elderly citizens is to a great extent related to the maintenance of independence. The risk of falling and the loss of autonomy are two frequent problems associated with ageing. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Persons Who Have Experienced a Sudden Uncontrolled Fall in the Absence of Outside Factors in the 6 Months Preceding the Consultation
- What is being tested?
- BERG scale, Functional tests and Measurement of balance on a force platform
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Dec 2016
- Phase
- Observational
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients followed at the Pôle de rééducation et de réadaptation
Who may be able to join
- Control group:
- Subjects who have provided written informed consent
- Subjects with national health insurance cover
- Subjects aged between 60 and 90 years old
- Able to understand simple instructions and exercise instructions and to provide informed consent
- with no diseases that could compromise postural abilities and ankle muscle strength.
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- Subjects who have not experience a sudden uncontrolled fall in the absence of outside factors in the 6 months preceding inclusion.
- Patients group
- Subjects who have provided written informed consent
- Subjects with national health insurance cover
- Subjects aged between 60 and 90 years old
- Able to understand simple instructions and exercise instructions and to provide informed consent
- Subjects who have experienced at least one sudden uncontrolled fall in the absence of outside factors in the 6 months preceding inclusion.
Who cannot join
- Acute balance disorders (central vestibular syndrome, infection or toxic cause)
- Chronic vestibular disease with proven clinical repercussions
- Any severe neuro-orthopedic disease impairing balance as well as physiological impairments due to ageing Any chronic neurological disorder (stroke, Parkinson syndrome…)
- Any psychiatric disorder able to compromise participation
- Non-corrected vision disorder
- Cancer or any progressive disease
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- Treatment with psychotropic agents able to impair vigilance and posture
- Patients under guardianship
- Patients with an ADL score <3 (total of 6 points), reflecting a clinically obvious high risk of falling
Trial locations and contacts
1 site in 1 country.
About this study
The quality of life of elderly citizens is to a great extent related to the maintenance of independence. The risk of falling and the loss of autonomy are two frequent problems associated with ageing. Although the impact of falls on functional outcomes and morbi-mortality in the elderly is well-established, the pathophysiological mechanisms underlying these falls are poorly understood. To better assess the risk of falling, numerous studies have investigated the use of dynamic and static posturography. These studies sought to characterise populations of fallers and non-fallers using parameters from postural analysis. Nonetheless, a new concept may emerge: weakening of the ankle movement muscles may be implicated in the age-related deterioration of posture. Even though it has been shown that this decrease occurs earlier and is more severe in fallers, the direct relationship between the strength of ankle movement muscles and balance parameters in elderly fallers has not yet been established. The existence of such a relationship would make it possible on the one hand to facilitate screening for those with a risk of falling, and on the other hand to enrich our understanding of the pathophysiology of the risk of falling. The perspective would therefore be to propose programmes focused on the strengthening of these deficient muscles.
- Being tested
- BERG scale, Functional tests, Measurement of balance on a force platform, Measurement of maximal moment of the plantar flexor and dorsiflexor muscles, Measurement of the moment of the plantar flexors and dorsiflexors corresponding to RMS activity during balance measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BERG scaleOther
Complete the BERG balance scale
Functional testsOther
timed up and go, Mini motor test, retropulsion test
Measurement of balance on a force platformOther
4 trials of 30 seconds x 2 conditions (eyes open; eyes closed)
Measurement of maximal moment of the plantar flexor and dorsiflexor musclesOther
5-second repetitions
Measurement of the moment of the plantar flexors and dorsiflexors corresponding to RMS activity during balance measurementsOther
3 10-second repetitions
| Study group | Role | What they receive |
|---|---|---|
| Patient | Not described Receives: Other: BERG scale; Other: Functional tests; Other: Measurement of balance on a force platform; Other: Measurement of maximal moment of the plantar flexor and dorsiflexor muscles; Other: Measurement of the moment of the plantar flexors and dorsiflexors corresponding to RMS activity during balance measurements | |
| Control | Not described Receives: Other: BERG scale; Other: Functional tests; Other: Measurement of balance on a force platform; Other: Measurement of maximal moment of the plantar flexor and dorsiflexor muscles; Other: Measurement of the moment of the plantar flexors and dorsiflexors corresponding to RMS activity during balance measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sum of the moments of strength developed by the plantar flexor and dorsiflexor muscles (i.e. combined moment) in both ankles
Measured: Through study completion, an average of 1 month
Mean total displacement of the Centre of Pressure in millimetres during the different stabilometry recordings.
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startMar 2011
- Primary completionMay 2014
- Study completionDec 2016
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 Persons Who Have Experienced a Sudden Uncontrolled Fall in the Absence of Outside Factors in the 6 Months Preceding the ConsultationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343769
- Sponsor's protocol ID
- GREMEAUX DRCI 2009-2
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2017
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cattagni T, Scaglioni G, Laroche D, Gremeaux V, Martin A. The involvement of ankle muscles in maintaining balance in the upright posture is higher in elderly fallers. Exp Gerontol. 2016 May;77:38-45. doi: 10.1016/j.exger.2016.02.010. Epub 2016 Feb 16.
PubMed 26899564
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship Between the Strength of Ankle Movement Muscles and Postural Parameters in Elderly Fallers: Towards New Strategies for Screening and Management
- ClinicalTrials.gov ID
- NCT03343769
- Acronym / sponsor ID
- GREMEAUX DRCI 2009-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
The quality of life of elderly citizens is to a great extent related to the maintenance of independence. The risk of falling and the loss of autonomy are two frequent problems associated with ageing. Although the impact of falls on functional outcomes and morbi-mortality in the elderly is well-established, the pathophysiological mechanisms underlying these falls are poorly understood. To better assess the risk of falling, numerous studies have investigated the use of dynamic and static posturography. These studies sought to characterise populations of fallers and non-fallers using parameters from postural analysis. Nonetheless, a new concept may emerge: weakening of the ankle movement muscles may be implicated in the age-related deterioration of posture. Even though it has been shown that this decrease occurs earlier and is more severe in fallers, the direct relationship between the strength of ankle movement muscles and balance parameters in elderly fallers has not yet been established. The existence of such a relationship would make it possible on the one hand to facilitate screening for those with a risk of falling, and on the other hand to enrich our understanding of the pathophysiology of the risk of falling. The perspective would therefore be to propose programmes focused on the strengthening of these deficient muscles.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: BERG scale, Other: Functional tests, Other: Measurement of balance on a force platform, Other: Measurement of maximal moment of the plantar flexor and dorsiflexor muscles, Other: Measurement of the moment of the plantar flexors and dorsiflexors corresponding to RMS activity during balance measurements |
| Control | – | Other: BERG scale, Other: Functional tests, Other: Measurement of balance on a force platform, Other: Measurement of maximal moment of the plantar flexor and dorsiflexor muscles, Other: Measurement of the moment of the plantar flexors and dorsiflexors corresponding to RMS activity during balance measurements |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients followed at the Pôle de rééducation et de réadaptation
Key inclusion criteria (13 listed)
- Subjects who have provided written informed consent
- Subjects with national health insurance cover
- Subjects aged between 60 and 90 years old
- Able to understand simple instructions and exercise instructions and to provide informed consent
- with no diseases that could compromise postural abilities and ankle muscle strength.
Key exclusion criteria (9 listed)
- Acute balance disorders (central vestibular syndrome, infection or toxic cause)
- Chronic vestibular disease with proven clinical repercussions
- Any severe neuro-orthopedic disease impairing balance as well as physiological impairments due to ageing Any chronic neurological disorder (stroke, Parkinson syndrome…)
- Any psychiatric disorder able to compromise participation
- Non-corrected vision disorder
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 |
|---|---|---|
| BERG scaleComplete the BERG balance scale | Other | Control, Patient |
| Functional teststimed up and go, Mini motor test, retropulsion test | Other | Control, Patient |
| Measurement of balance on a force platform4 trials of 30 seconds x 2 conditions (eyes open; eyes closed) | Other | Control, Patient |
| Measurement of maximal moment of the plantar flexor and dorsiflexor muscles5-second repetitions | Other | Control, Patient |
| Measurement of the moment of the plantar flexors and dorsiflexors corresponding to RMS activity during balance measurements3 10-second repetitions | Other | Control, Patient |
Primary outcome
The sum of the moments of strength developed by the plantar flexor and dorsiflexor muscles (i.e. combined moment) in both ankles
Time frame: Through study completion, an average of 1 month
Mean total displacement of the Centre of Pressure in millimetres during the different stabilometry recordings.
Time frame: Through study completion, an average of 1 month
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 4 Feb 2026.
- Results publication: PubMed 26899564Cattagni T, Scaglioni G, Laroche D, Gremeaux V, Martin A. The involvement of ankle muscles in maintaining balance in the upright posture is higher in elderly fallers. Exp Gerontol. 2016 May;77:38-45. doi: 10.1016/j.exger.2016.02.010. Epub 2016 Feb 16.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persons Who Have Experienced a Sudden Uncontrolled Fall in the Absence of Outside Factors in the 6 Months Preceding the Consultation, run by Centre Hospitalier Universitaire Dijon 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 13 inclusion and 9 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 4 Feb 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?
The sum of the moments of strength developed by the plantar flexor and dorsiflexor muscles (i.e. combined moment) in both ankles (time frame: Through study completion, an average of 1 month). The study lists 2 primary outcomes in all. 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 NCT03343769, 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 4 Feb 2026.