Prediction of Peripheral Neuropathy With Functional Testing

NCT06933108 | Recruiting

• 1 other identifier: UCO20250326
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes and chronic kidney disease (CKD) are two distinct pathologies. The former is defined as an impairment in insulin production and/or utilization, while the latter refers to structural or functional abnormalities of the kidneys. However, these two diseases share a common complication: peripheral neuropathy. This condition affects between 50% and 60% of patients with diabetes or CKD. Peripheral neuropathy involves the destruction of sensory and motor neurons, leading to a wide range of painful symptoms while also reducing force production capacity. Among the diagnostic tests used, the most accessible clinical tests suffer from high variability due to human subjectivity (e.g., the tuning fork test, which requires examiner expertise and verbal patient feedback), whereas laboratory electrophysiological tests can only detect the largest neurons, which are affected at later stages. Although composite clinical tests have been developed to improve neuropathy screening performance, they still inherit the limitations of their individual components. In other words, they remain subject to variability related to the examiner's experience and the patient's ability to understand instructions, while also being performed through various procedures that lack a standardized consensus. Moreover, these composite scores are particularly time-consuming and are therefore rarely used in clinical practice. As a result, no method currently allows for large-scale, early, and reliable screening of peripheral neuropathy. Our recent work and emerging studies suggest that assessing functional capacities could serve as an objective and early marker of neuropathic impairment, even before clinical diagnosis. Specifically, the quantification of postural balance performance using stabilometric methods (i.e., center of pressure displacement area) and unipedal balance time could predict the presence of diabetes-related peripheral neuropathy with over 95% accuracy compared to diagnosis with a composite clinical method (unpublished results). Therefore, the aim of this study is to evaluate physical and balance capacities assessed during routine care in adapted physical activity settings, in order to determine whether the development of a composite score could help estimate the risk of peripheral neuropathy in individuals with diabetes and CKD.

Conditions

Chronic Kidney Disease Stage 3 and 4; Diabetes

Outcome Measures

Primary Outcomes (1)

• Composite score derived from the statistical model

  The composite score will be built with the performances at the functional tests (independant variables) using a logistic backward regression model, to predict peripheral neuropathy (dependant variable: yes or no). The score will range from 0 to 1. Higher is the score, higher is the risk of peripheral neuropathy. Dependant variables: Michigan Neuropathy Screening Instrument, to diagnosis peripheral neuropathy. Independant variables: Maximal dorsiflexion and plantar flexion of the ankle, maximal hallux flexion, 10-meter walking test (speed, cadence), postural balance, Timed-up and Go, and two proprioceptive tests (Joint Position Sense and the Star Excursion Balance Test).

  Transversal study : At baseline

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Le Mans Hospital, from nephrology and endocrinology unit

You may qualify if:

• CKD stage 4-5 and / or diabetes (Type I or II)
• Able to walk 20 m
• BMI \< 35

You may not qualify if:

• Currently or planning dialysis
• Musculoskeletal, osteorarticular and neurological disease(s)
• Cognitive impairment
• Low-limb amputation

Sponsors & Collaborators

• Université catholique de l'Ouest: lead
• Centre Hospitalier le Mans: collaborator
• Le Mans Universite: collaborator

Study Sites (1)

Centre Hospitalier Le Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Giorgina Barbara Piccoli, Professor, Medical Doctor

CONTACT

0243434343; gpiccoli@ch-lemans.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 18, 2025
• Study Start: January 27, 2025
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

FR (1)