Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Neuropathy, Somatosensory Disorders, Sensorimotor Gait Disorder

Intervention / Treatment
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* Behavioral: sensorimotor training based on Feldenkrais method
* Behavioral: foot care education
* Combination Product: usual care


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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 arms and single blinded randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>control arm: usual care and foot care education. | Behavioral: foot care education<br>* Recommendations for preventing foot ulcers<br>Combination Product: usual care<br>* drugs and diet usual care<br>|
| Experimental: experimental<br>experimental arm: sensorimotor training, foot care education and usual care | Behavioral: sensorimotor training based on Feldenkrais method<br>* 8 weeks of balance and sensorimotor training twice a week<br>Behavioral: foot care education<br>* Recommendations for preventing foot ulcers<br>Combination Product: usual care<br>* drugs and diet usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gait, diabetes, sensorimotor training, peripheral neuropathy, somatosensory system, postural control, quality of life, fear of falling, Feldenkrais method