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Evaluation of Rocker sOles in Diabetis

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02891928
Acronym
EROD
Enrollment
25
Registered
2016-09-08
Start date
2014-12-31
Completion date
2016-06-30
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy

Keywords

Type 2 diabetes, Diabetic neuropathy, Disorders of equilibrium, Rocker sole shoes, Walking

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?

Interventions

DEVICERocker sole shoes

Measure of walk testing Measure of standing position

DEVICENormal shoes

Measure of walk testing Measure of standing position

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Anteroposterior displacement amount of the center of pressure with regard to the center of mass.InclusionDisplacement of the center of pressure is measured during a 55 sec session of standing position with dedicated shoes with of force plateform

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026