Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05262946
• Other study ID #: DiabetesBalanceOne
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: January 30, 2022

Study information

• Verified date: March 2021
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 30, 2022
• Est. primary completion date: December 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Exclusion Criteria: amputation and cognitive or mental issues

-

Related Conditions & MeSH terms

• Disease
• Gait Disorders, Neurologic
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Sensorimotor Gait Disorder
• Somatosensory Disorders

Intervention

Behavioral:
• sensorimotor training based on Feldenkrais method
8 weeks of balance and sensorimotor training twice a week
• foot care education
Recommendations for preventing foot ulcers

Combination Product:
• usual care
drugs and diet usual care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up and Go test	postural control test	2 years
Secondary	Four Square Step test	ability walking in different directions	2 years
Secondary	Tinetti- Performance-Oriented Mobility Assessment (POMA-T)	static and dynamic postural control	2 years
Secondary	Falls Efficacy Scale	It measures the fear of falling, ranging from 0 to 64, being higher scores worst outcome results	2 years
Secondary	SF-36 Health Survey questionnaire , 1.4 version.	Quality of life health-related questionnaire	2 years
Secondary	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