Evaluation of Rocker sOles in Diabetis

NCT02891928 | Completed Phase 4

• 1 other identifier: ROCKER SOLE (RB 14.143)
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

with rocker sole

EXPERIMENTAL

patient were wearing the rocker soles shoes during investigation

Device: Rocker sole shoes

without rocker sole

PLACEBO COMPARATOR

patient were wearing normal shoes during investigation

Device: Normal shoes

Interventions

Rocker sole shoes DEVICE

Measure of walk testing Measure of standing position

with rocker sole

Normal shoes DEVICE

Measure of walk testing Measure of standing position

without rocker sole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Related Publications (1)

• 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.

  PMID: 26269202 RESULT

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Olivier Remy-Neris, Professor

  CHRU de Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 8, 2016
• Study Start: December 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 3, 2025

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)