NCT05262946

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 31, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
Last Updated

November 4, 2022

Status Verified

March 1, 2021

Enrollment Period

4 years

First QC Date

January 31, 2022

Last Update Submit

November 3, 2022

Conditions

Peripheral NeuropathySomatosensory DisordersSensorimotor Gait Disorder

Keywords

gaitdiabetessensorimotor trainingperipheral neuropathysomatosensory systempostural controlquality of lifefear of fallingFeldenkrais method

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Up and Go test

    2 years

  • Four Square Step test

    2 years

  • Tinetti- Performance-Oriented Mobility Assessment (POMA-T)

    2 years

  • Falls Efficacy Scale

    2 years

  • SF-36 Health Survey questionnaire , 1.4 version.

    2 years

  • +1 more secondary outcomes

Study Arms (2)

control

ACTIVE COMPARATOR

control arm: usual care and foot care education.

Behavioral: foot care educationCombination Product: usual care

experimental

EXPERIMENTAL

experimental arm: sensorimotor training, foot care education and usual care

Behavioral: sensorimotor training based on Feldenkrais methodBehavioral: foot care educationCombination Product: usual care

Interventions

sensorimotor training based on Feldenkrais methodBEHAVIORAL

8 weeks of balance and sensorimotor training twice a week

experimental
foot care educationBEHAVIORAL

Recommendations for preventing foot ulcers

controlexperimental
usual careCOMBINATION_PRODUCT

drugs and diet usual care

controlexperimental

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jimenez-Mazuelas MJ, Gonzalez-Perez de Villar N, De Casas-Albendea S, Martinez-Gimeno L, Jimenez-Gonzalez S, Angulo-Carrere MT. Somatosensory and dynamic balance improvement in older adults with diabetic peripheral neuropathy through sensorimotor exercise: A multisite randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:2062-2073. doi: 10.1016/j.jbmt.2024.10.041. Epub 2024 Oct 24.

    PMID: 39593566DERIVED

MeSH Terms

Conditions

Peripheral Nervous System DiseasesSomatosensory DisordersGait Disorders, NeurologicDiabetes Mellitus

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • MARIA TERESA ANGULO CARRERA, DR

    UNIVERSIDAD COMPLUTENSE MADRID

    STUDY DIRECTOR

  • NOEMI GONZALEZ PEREZ DE VILLAR, DR

    HOSPITAL UNIVERSITARIO DE LA PAZ

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
measurements and statistical analysis were made without knowing who participated in control or experimental group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 arms and single blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

March 2, 2022

Study Start

January 1, 2016

Primary Completion

December 22, 2019

Study Completion

January 30, 2022

Last Updated

November 4, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share