Analysis of the Biomechanics of Walking

Falls Clinical Trial

Official title:

Analysis of the Biomechanics of Walking in the Senior Under the Terms of Footwear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547285
• Other study ID #: 1208136
• Secondary ID: 2012-A01193-40
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: September 10, 2015
• Start date: February 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

The proportion of people aged 60 and over in the French population has increased from 18% in 1970 to over 22% in 2010.

One major problem in the elderly is falling. About half of these falls cause a minor injury and between 5% and 25% will cause a more serious injury such as a fracture or a sprain (Alexander et al., 1992; Nevitt et al., 1991).

It therefore seems essential to study the locomotion of seniors to limit the maximum risk of falling into a public health measure.

Two factors may be involved:

1. The first corresponds to factors related to natural aging topics

2. The second is the environment that is a real problem for seniors (Rolling showers, presence of works ....) And especially the port of inappropriate footwear.

Indeed, most of the elderly, institutionalized or not, do not wear proper shoes. It is this parameter that will be highlighted in our study.

Description:

The subjects will test different characteristics on the same shoe. A single parameter vary for each condition (Different insole, heel height, stem length ...) For each condition, analysis of locomotion on treadmill ADAL be performed as well as tests on postural balance platform. Kinematic measurements, accelerometer and postural will be performed for each subject.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 79 Years

Eligibility

Inclusion Criteria:

• Topic of footwear for women 37-38-39 and 41-42-43 for men

Exclusion Criteria:

• Presence major pathology, fracture or surgery, at the musculoskeletal system, under 3 years

• Presence of prosthesis in the lower limb (hip, knee, ankle)

• Presence of hallux valgus or pronounced toe claw,

• Diabetes,

• Presence of osteoarthritis in the lower limbs

• Presence of medication or other problems affecting the balance of subjects.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Elderly People
• Falls

Intervention

Other:
• Shoes characteristics
A single parameter of shoe vary for each test (Different insole, heel height, stem length ...)

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best stability shoe	The pair of shoe that will provide the best comfort and driving stability defined by (composite measure) : the largest step; and the small time single support; and the lowest medial-lateral force to ADAL carpet; and the smallest ellipse surface	1 year	No