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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


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
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