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Clinical Trials/NCT05262946
NCT05262946
Completed
Not Applicable

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

Universidad Complutense de Madrid0 sites44 target enrollmentJanuary 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Neuropathy
Sponsor
Universidad Complutense de Madrid
Enrollment
44
Primary Endpoint
Cumulative Somatosensory Impairment Index
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
January 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Cumulative Somatosensory Impairment Index

Time Frame: 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 Outcomes

  • Four Square Step test(2 years)
  • Up and Go test(2 years)
  • SF-36 Health Survey questionnaire , 1.4 version.(2 years)
  • Tinetti- Performance-Oriented Mobility Assessment (POMA-T)(2 years)
  • Falls Efficacy Scale(2 years)
  • Validated Spanish version of Short-Form Late-Life Function and Disability Instrument(2 years)

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