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Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05262946
Enrollment
44
Registered
2022-03-02
Start date
2016-01-01
Completion date
2022-01-30
Last updated
2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathy, Sensorimotor Gait Disorder, Somatosensory Disorders

Keywords

gait, diabetes, sensorimotor training, peripheral neuropathy, somatosensory system, postural control, quality of life, fear of falling, Feldenkrais method

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.

Interventions

BEHAVIORALsensorimotor training based on Feldenkrais method

8 weeks of balance and sensorimotor training twice a week

BEHAVIORALfoot care education

Recommendations for preventing foot ulcers

COMBINATION_PRODUCTusual care

drugs and diet usual care

Sponsors

Universidad Complutense de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

2 arms and single blinded randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

amputation and cognitive or mental issues \-

Design outcomes

Primary

MeasureTime frameDescription
Cumulative Somatosensory Impairment Index2 yearsIt 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

MeasureTime frameDescription
Four Square Step test2 yearsability walking in different directions
Tinetti- Performance-Oriented Mobility Assessment (POMA-T)2 yearsstatic and dynamic postural control
Up and Go test2 yearspostural control test
SF-36 Health Survey questionnaire , 1.4 version.2 yearsQuality of life health-related questionnaire
Validated Spanish version of Short-Form Late-Life Function and Disability Instrument2 yearsIt measures functional disabilities and frequency of daily life activities, ranging from 31 to 155 and being higher scores better outcome results.
Falls Efficacy Scale2 yearsIt measures the fear of falling, ranging from 0 to 64, being higher scores worst outcome results

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026