NCT03343769

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

November 13, 2017

Last Update Submit

February 2, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • The sum of the moments of strength developed by the plantar flexor and dorsiflexor muscles (i.e. combined moment) in both ankles

    Through study completion, an average of 1 month

  • Mean total displacement of the Centre of Pressure in millimetres during the different stabilometry recordings.

    Through study completion, an average of 1 month

Study Arms (2)

Patient

Other: BERG scaleOther: Functional testsOther: Measurement of balance on a force platformOther: Measurement of maximal moment of the plantar flexor and dorsiflexor musclesOther: Measurement of the moment of the plantar flexors and dorsiflexors corresponding to RMS activity during balance measurements

Control

Other: BERG scaleOther: Functional testsOther: Measurement of balance on a force platformOther: Measurement of maximal moment of the plantar flexor and dorsiflexor musclesOther: Measurement of the moment of the plantar flexors and dorsiflexors corresponding to RMS activity during balance measurements

Interventions

Complete the BERG balance scale

ControlPatient

timed up and go, Mini motor test, retropulsion test

ControlPatient

4 trials of 30 seconds x 2 conditions (eyes open; eyes closed)

ControlPatient

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients followed at the Pôle de rééducation et de réadaptation

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 17, 2017

Study Start

March 1, 2011

Primary Completion

May 1, 2014

Study Completion

December 1, 2016

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations