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Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

Primary Purpose

Peripheral Neuropathy, Somatosensory Disorders, Sensorimotor Gait Disorder

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

sensorimotor training based on Feldenkrais method

foot care education

usual care

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring gait, diabetes, sensorimotor training, peripheral neuropathy, somatosensory system, postural control, quality of life, fear of falling, Feldenkrais method

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria: amputation and cognitive or mental issues

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control

experimental

Arm Description

control arm: usual care and foot care education.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Up and Go test

postural control test

Four Square Step test

ability walking in different directions

Tinetti- Performance-Oriented Mobility Assessment (POMA-T)

static and dynamic postural control

Falls Efficacy Scale

It measures the fear of falling, ranging from 0 to 64, being higher scores worst outcome results

SF-36 Health Survey questionnaire , 1.4 version.

Quality of life health-related questionnaire

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.

Full Information

NCT ID

NCT05262946

First Posted

January 31, 2022

Last Updated

November 3, 2022

Sponsor

Universidad Complutense de Madrid

1. Study Identification

Unique Protocol Identification Number

NCT05262946

Brief Title

Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

December 22, 2019 (Actual)

Study Completion Date

January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Neuropathy, Somatosensory Disorders, Sensorimotor Gait Disorder

Keywords

gait, diabetes, sensorimotor training, peripheral neuropathy, somatosensory system, postural control, quality of life, fear of falling, Feldenkrais method

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

2 arms and single blinded randomized controlled trial

Masking

InvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

Active Comparator

Arm Description

control arm: usual care and foot care education.

Arm Title

experimental

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

sensorimotor training based on Feldenkrais method

Intervention Description

8 weeks of balance and sensorimotor training twice a week

Intervention Type

Behavioral

Intervention Name(s)

foot care education

Intervention Description

Recommendations for preventing foot ulcers

Intervention Type

Combination Product

Intervention Name(s)

usual care

Intervention Description

drugs and diet usual care

Primary Outcome Measure Information:

Title

Cumulative Somatosensory Impairment Index

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Up and Go test

Description

postural control test

Time Frame

2 years

Title

Four Square Step test

Description

ability walking in different directions

Time Frame

2 years

Title

Tinetti- Performance-Oriented Mobility Assessment (POMA-T)

Description

static and dynamic postural control

Time Frame

2 years

Title

Falls Efficacy Scale

Description

It measures the fear of falling, ranging from 0 to 64, being higher scores worst outcome results

Time Frame

2 years

Title

SF-36 Health Survey questionnaire , 1.4 version.

Description

Quality of life health-related questionnaire

Time Frame

2 years

Title

Validated Spanish version of Short-Form Late-Life Function and Disability Instrument

Description

It measures functional disabilities and frequency of daily life activities, ranging from 31 to 155 and being higher scores better outcome results.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: having peripheral neuropathy and history of falls or risk factors for it. Current ulcer - Exclusion Criteria: amputation and cognitive or mental issues -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MARIA TERESA ANGULO CARRERA, DR

Organizational Affiliation

UNIVERSIDAD COMPLUTENSE MADRID

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

NOEMI GONZALEZ PEREZ DE VILLAR, DR

Organizational Affiliation

HOSPITAL UNIVERSITARIO DE LA PAZ

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

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