Chronic Kidney Disease Stage 3 and 4, Diabetes
Conditions
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diabetes-related peripheral neuropathy with over 95% accuracy compared to diagnosis with a composite clinical method (unpublished results).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.
Interventions
None listed
Sponsors
Centre Hospitalier le Mans
Le Mans Universite
Université catholique de l'Ouest
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite score derived from the statistical model | Transversal study : At baseline | 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). |
Countries
France
Contacts
Primary ContactGiorgina Barbara Piccoli, Professor, Medical Doctor
Outcome results
None listed