Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

Somatosensory Restoration and Postural Control Improvement in People With Diabetic Peripheral Neuropathy Applying Sensorimotor Training: a Multicentric Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Neuropathy; Somatosensory Disorders; Sensorimotor Gait Disorder
• Intervention / Treatment: Behavioral: foot care education; Combination product: usual care; Behavioral: sensorimotor training based on Feldenkrais method

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; control arm: usual care and foot care education.	Behavioral: foot care education; Recommendations for preventing foot ulcers; Combination product: usual care; drugs and diet usual care
Experimental: experimental; experimental arm: sensorimotor training, foot care education and usual care	Behavioral: foot care education; Recommendations for preventing foot ulcers; Combination product: usual care; drugs and diet usual care; Behavioral: sensorimotor training based on Feldenkrais method; 8 weeks of balance and sensorimotor training twice a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Somatosensory Impairment Index	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	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Study Director: MARIA TERESA ANGULO CARRERA, DR, Universidad Complutense Madrid; Study Director: NOEMI GONZALEZ PEREZ DE VILLAR, DR, Hospital Universitario de La Paz

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 22, 2019
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: diabetes; gait; quality of life; peripheral neuropathy; postural control; fear of falling; sensorimotor training; somatosensory system; Feldenkrais method
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Sensation Disorders; Disease; Peripheral Nervous System Diseases; Gait Disorders, Neurologic; Somatosensory Disorders
• Other Study ID Numbers: DiabetesBalanceOne

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No