Prediction of Peripheral Neuropathy With Functional Testing (PredictNP)

Estimate the Risk of Diabetic and Uremic Peripheral Neuropathy Using Physical and Functional Testing

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diabetes-related peripheral neuropathy with over 95% accuracy compared to diagnosis with a composite clinical method (unpublished results).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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Chronic Kidney Disease Stage 3 and 4

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Giorgina Barbara Piccoli, Professor, Medical Doctor; Phone Number: +33 0243434343; Email: gpiccoli@ch-lemans.fr

Study Locations

• France
  • Le Mans, France, 72000
    • Recruiting
    • Centre Hospitalier Le Mans
    • Contact: Giorgina Barbara Piccoli, Professor, Medical Doctor; Phone Number: +33 0243434343; Email: gpiccoli@ch-lemans.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Le Mans Hospital, from nephrology and endocrinology unit

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Université catholique de l'Ouest
• Collaborators: Centre Hospitalier le Mans; Le Mans Universite

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): May 2, 2025
• Study Completion (Estimated): May 2, 2025

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Nervous System Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Renal Insufficiency; Peripheral Nervous System Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: UCO20250326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Because the power of the prediciton will be based on the data. So the data cannot be shared before publication.

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No