Study of the Relationship Between the Strength of Ankle Movement Muscles and Postural Parameters … (NCT03343769) | Clinical Trial Compass
CompletedNot Applicable
Study of the Relationship Between the Strength of Ankle Movement Muscles and Postural Parameters in Elderly Fallers: Towards New Strategies for Screening and Management
France34 participantsStarted 2011-03
Plain-language 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. 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.
Who can participate
Age range
60 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
* 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.
Exclusion Criteria:
* 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
* Treatment with psychotropic agents able to impair vigilance and posture
* Patients under guardianship
* Patients with an ADL s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The sum of the moments of strength developed by the plantar flexor and dorsiflexor muscles (i.e. combined moment) in both ankles
Timeframe: Through study completion, an average of 1 month
2
Mean total displacement of the Centre of Pressure in millimetres during the different stabilometry recordings.
Timeframe: Through study completion, an average of 1 month