- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03343769
Study of the Relationship Between the Strength of Ankle Movement Muscles and Postural Parameters in Elderly Fallers: Towards New Strategies for Screening and Management
November 15, 2017 updated by: Centre Hospitalier Universitaire Dijon
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 Overview
Status
Completed
Intervention / Treatment
- 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
Study Type
Observational
Enrollment (Actual)
34
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Dijon, France, 21000
- CHU Dijon Bourgogne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients followed at the Pôle de rééducation et de réadaptation
Description
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 score <3 (total of 6 points), reflecting a clinically obvious high risk of falling
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
|
Complete the BERG balance scale
timed up and go, Mini motor test, retropulsion test
4 trials of 30 seconds x 2 conditions (eyes open; eyes closed)
5-second repetitions
3 10-second repetitions
|
Patient
|
Complete the BERG balance scale
timed up and go, Mini motor test, retropulsion test
4 trials of 30 seconds x 2 conditions (eyes open; eyes closed)
5-second repetitions
3 10-second repetitions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Through study completion, an average of 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2011
Primary Completion (ACTUAL)
May 1, 2014
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
November 13, 2017
First Submitted That Met QC Criteria
November 13, 2017
First Posted (ACTUAL)
November 17, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 17, 2017
Last Update Submitted That Met QC Criteria
November 15, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- GREMEAUX DRCI 2009-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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