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Evaluation of Rocker sOles in Diabetis (EROD)

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ClinicalTrials.gov Identifier: NCT02891928
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Device: Rocker sole shoes Device: Normal shoes Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Evaluation of Standard Wearing Shoes With Rocker Sole Shoes in Diabetic Patients With Neuropathy
Study Start Date : December 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: with rocker sole
patient were wearing the rocker soles shoes during investigation
Device: Rocker sole shoes
Measure of walk testing Measure of standing position

Placebo Comparator: without rocker sole
patient were wearing normal shoes during investigation
Device: Normal shoes
Measure of walk testing Measure of standing position




Primary Outcome Measures :
  1. Anteroposterior displacement amount of the center of pressure with regard to the center of mass. [ Time Frame: Inclusion ]
    Displacement of the center of pressure is measured during a 55 sec session of standing position with dedicated shoes with of force plateform



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891928


Locations
France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Olivier Remy-Neris, Professor CHRU de Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02891928     History of Changes
Other Study ID Numbers: ROCKER SOLE (RB 14.143)
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data are not planned to be shared

Keywords provided by University Hospital, Brest:
Type 2 diabetes
Diabetic neuropathy
Disorders of equilibrium
"Rocker sole" shoes
Walking

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases