Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

NCT ID: NCT05262946

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2022-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Adults with diabetic peripheral neuropathy tend to fall more frequently than healthy population as a consequence of multiple sensorimotor and cognitive damages. In this protocol study, a randomized controlled trial is proposed using a sensorimotor intervention based on Feldenkrais method to improve somatosensory aspects and, therefore, postural control of participants.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Among all the systems suffering damage due to hyperglucemia toxicity in diabetes, somatosensory system, composed by proprioception and skin sensory receptors has a key role since it is in charge of the faster body reaction when a postural control response is needed. Despite of it, few studies have focused on this issue. This randomized controlled trial proposed a safe and easy training adapted to adults and old people with diabetic peripheral neuropathy. Pressure, touch, proprioception and graphesthesia sensibility were measured, as well as functionality in daily basis, quality of life and fear of falling.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Neuropathy Somatosensory Disorders Sensorimotor Gait Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 arms and single blinded randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
measurements and statistical analysis were made without knowing who participated in control or experimental group

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control

control arm: usual care and foot care education.

Group Type ACTIVE_COMPARATOR

foot care education

Intervention Type BEHAVIORAL

Recommendations for preventing foot ulcers

usual care

Intervention Type COMBINATION_PRODUCT

drugs and diet usual care

experimental

experimental arm: sensorimotor training, foot care education and usual care

Group Type EXPERIMENTAL

sensorimotor training based on Feldenkrais method

Intervention Type BEHAVIORAL

8 weeks of balance and sensorimotor training twice a week

foot care education

Intervention Type BEHAVIORAL

Recommendations for preventing foot ulcers

usual care

Intervention Type COMBINATION_PRODUCT

drugs and diet usual care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sensorimotor training based on Feldenkrais method

8 weeks of balance and sensorimotor training twice a week

Intervention Type BEHAVIORAL

foot care education

Recommendations for preventing foot ulcers

Intervention Type BEHAVIORAL

usual care

drugs and diet usual care

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

\-
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MARIA TERESA ANGULO CARRERA, DR

Role: STUDY_DIRECTOR

UNIVERSIDAD COMPLUTENSE MADRID

NOEMI GONZALEZ PEREZ DE VILLAR, DR

Role: STUDY_DIRECTOR

HOSPITAL UNIVERSITARIO DE LA PAZ

References

Explore related publications, articles, or registry entries linked to this study.

Jimenez-Mazuelas MJ, Gonzalez-Perez de Villar N, De Casas-Albendea S, Martinez-Gimeno L, Jimenez-Gonzalez S, Angulo-Carrere MT. Somatosensory and dynamic balance improvement in older adults with diabetic peripheral neuropathy through sensorimotor exercise: A multisite randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:2062-2073. doi: 10.1016/j.jbmt.2024.10.041. Epub 2024 Oct 24.

Reference Type DERIVED
PMID: 39593566 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DiabetesBalanceOne

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.