Evaluation of Rocker sOles in Diabetis

NCT ID: NCT02891928

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-06-30

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?

Conditions

Diabetic Neuropathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

with rocker sole

patient were wearing the rocker soles shoes during investigation

Group Type: EXPERIMENTAL

Rocker sole shoes

Intervention Type: DEVICE

Measure of walk testing Measure of standing position

without rocker sole

patient were wearing normal shoes during investigation

Group Type: PLACEBO_COMPARATOR

Normal shoes

Intervention Type: DEVICE

Measure of walk testing Measure of standing position

Interventions

Rocker sole shoes

Measure of walk testing Measure of standing position

Intervention Type: DEVICE

Normal shoes

Measure of walk testing Measure of standing position

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Remy-Neris, Professor

Role: PRINCIPAL_INVESTIGATOR

CHRU de Brest

Locations

CHRU de Brest

Brest, , France

Countries

France

References

Lumeau M, Lempereur M, Remy-Neris O. Assessment of the rocker sole shoes on postural stability in diabetic patients with distal sensory neuropathy. Comput Methods Biomech Biomed Engin. 2015;18 Suppl 1:1986-7. doi: 10.1080/10255842.2015.1070588. Epub 2015 Aug 13. No abstract available.

Reference Type: RESULT

PMID: 26269202 (View on PubMed)

Other Identifiers

ROCKER SOLE (RB 14.143)

Identifier Type: -

Identifier Source: org_study_id