Evaluation of Rocker sOles in Diabetis

Phase 4

Completed

• Conditions: Diabetic Neuropathy
• Interventions: Device: Normal shoes; Device: Rocker sole shoes

• Registration Number: NCT02891928
• Lead Sponsor: University Hospital, Brest

Brief Summary

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

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?

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-08-26
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-01
• Last Update Submitted: 2016-09-01
• Study First Posted: 2016-09-08
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
without rocker sole	Normal shoes	patient were wearing normal shoes during investigation
with rocker sole	Rocker sole shoes	patient were wearing the rocker soles shoes during investigation

Primary Outcome Measures

Name	Time	Method
Anteroposterior displacement amount of the center of pressure with regard to the center of mass.	Inclusion	Displacement of the center of pressure is measured during a 55 sec session of standing position with dedicated shoes with of force plateform

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France