Evaluation of Rocker sOles in Diabetis

Study Overview
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Brief Summary
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The purpose of this study is to determine if the wearing of shoes rocker sole type prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of equilibrium.

Detailed Description
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Diabetes is a public health problem. The functional prognosis is partly conditioned by the occurrence of wounds at the level of the foot affected by neuropathy and/or arteriopathy. Preventive measures are necessary to avoid such complications: education, pedicure, suitable footwear, insoles. There are many types of orthopedic shoes, standard or custom-made. A key objective is to avoid excessive pressure found at the level of the front-foot, favoring the appearance of lesions like ulcers. In this context, the Anglo-Saxons have developed a type of shoe ( rocker sole), allowing to decrease the pressures on the front-foot with a rigid sole system associated with an elevation of the front-foot. Some, however, have shown that this type of shoe may be responsible for disorders of equilibrium to the healthy subject, what about at the diabetic patients, already at higher risk of postural disorders and falls?

Official Title
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Comparative Evaluation of Standard Wearing Shoes With Rocker Sole Shoes in Diabetic Patients With Neuropathy

Conditions
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Diabetic Neuropathy

Intervention / Treatment
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* Device: Rocker sole shoes
* Device: Normal shoes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Type 2 Diabetes Patients suffering from diabetic neuropathy diagnosed by the test in the monostrand Can walk without technical assistance Age from 18 to 75 Having made his non-opposition Exclusion Criteria: Presence of ulceration of the foot (or a history of this type) History of pathologies that could disturb the balance and walking independently of diabetes: vestibular diseases, ophthalmic diseases with decreased of visual acuity, neurological, musculoskeletal and rheumatic diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with rocker sole<br>patient were wearing the rocker soles shoes during investigation | Device: Rocker sole shoes<br>* Measure of walk testing Measure of standing position<br>|
| Placebo Comparator: without rocker sole<br>patient were wearing normal shoes during investigation | Device: Normal shoes<br>* Measure of walk testing Measure of standing position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anteroposterior displacement amount of the center of pressure with regard to the center of mass. | Displacement of the center of pressure is measured during a 55 sec session of standing position with dedicated shoes with of force plateform | Inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Diabetic neuropathy, Disorders of equilibrium, Rocker sole shoes, Walking