Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

Sponsor

Universidad Complutense de Madrid (Other)

Overall Status

Completed

CT.gov ID

NCT05262946

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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 to improve somatosensory aspects and, therefore, postural control of participants.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Neuropathy Somatosensory Disorders Sensorimotor Gait Disorder	Behavioral: sensorimotor training Behavioral: foot care education Combination Product: usual care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 arms and single blinded randomized controlled trial2 arms and single blinded randomized controlled trial

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Dec 22, 2019

Actual Study Completion Date :

Jan 30, 2022

Arms and Interventions

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: sensorimotor training 8 weeks of balance and sensorimotor training twice a week Behavioral: foot care education Recommendations for preventing foot ulcers Combination Product: usual care drugs and diet usual care

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: sensorimotor training

8 weeks of balance and sensorimotor training twice a week

Behavioral: foot care education

Recommendations for preventing foot ulcers

Combination Product: usual care

drugs and diet usual care

Outcome Measures

Primary Outcome Measures

Cumulative Somatosensory Impairment Index [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 Outcome Measures

Up and Go test [2 years]
postural control test
Four Square Step test [2 years]
ability walking in different directions
Tinetti- Performance-Oriented Mobility Assessment (POMA-T) [2 years]
static and dynamic postural control
Falls Efficacy Scale [2 years]
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. [2 years]
Quality of life health-related questionnaire
Validated Spanish version of Short-Form Late-Life Function and Disability Instrument [2 years]
It measures functional disabilities and frequency of daily life activities, ranging from 31 to 155 and being higher scores better outcome results.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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