Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

Not Applicable

Completed

• Conditions: Somatosensory Disorders; Sensorimotor Gait Disorder; Peripheral Neuropathy
• Interventions: Behavioral: sensorimotor training based on Feldenkrais method; Behavioral: foot care education; Combination Product: usual care

• Registration Number: NCT05262946
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2019-12-22
• Status Verified: 2021-03
• Study Completion: 2022-01-30
• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-02
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

having peripheral neuropathy and history of falls or risk factors for it. Current ulcer -

Exclusion Criteria

amputation and cognitive or mental issues

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	usual care	experimental arm: sensorimotor training, foot care education and usual care
experimental	sensorimotor training based on Feldenkrais method	experimental arm: sensorimotor training, foot care education and usual care
control	foot care education	control arm: usual care and foot care education.
control	usual care	control arm: usual care and foot care education.
experimental	foot care education	experimental arm: sensorimotor training, foot care education and usual care

Primary Outcome Measures

Name	Time	Method
Cumulative Somatosensory Impairment Index	2 years	It measures proprioception, pressure and vibration sensitivity and graphesthesia to sum up somatosensory function in lower legs. Iti is ranging from 0 to 8 being 8 the worst result

Secondary Outcome Measures

Name	Time	Method
Four Square Step test	2 years	ability walking in different directions
Up and Go test	2 years	postural control test
SF-36 Health Survey questionnaire , 1.4 version.	2 years	Quality of life health-related questionnaire
Tinetti- Performance-Oriented Mobility Assessment (POMA-T)	2 years	static and dynamic postural control
Falls Efficacy Scale	2 years	It measures the fear of falling, ranging from 0 to 64, being higher scores worst outcome results
Validated Spanish version of Short-Form Late-Life Function and Disability Instrument	2 years	It measures functional disabilities and frequency of daily life activities, ranging from 31 to 155 and being higher scores better outcome results.