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Completed

NCT Number: NCT05262946

Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

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.

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Key information

Conditions

Peripheral Neuropathy Diabetes Mellitus Endocrine System Diseases Gait Disorders, Neurologic Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sensation Disorders Sensorimotor Gait Disorder Signs and Symptoms Somatosensory Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

amputation and cognitive or mental issues

-

Treatment and study plan

sensorimotor training based on Feldenkrais method

Behavioral

8 weeks of balance and sensorimotor training twice a week

foot care education

Behavioral

Recommendations for preventing foot ulcers

Usual Care

Combination Product

drugs and diet usual care

Primary outcomes

  1. 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

  1. Up and Go test

    Time frame: 2 years

    postural control test

  2. Four Square Step test

    Time frame: 2 years

    ability walking in different directions

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

    Time frame: 2 years

    static and dynamic postural control

  4. Falls Efficacy Scale

    Time frame: 2 years

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

  5. SF-36 Health Survey questionnaire , 1.4 version.

    Time frame: 2 years

    Quality of life health-related questionnaire

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

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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