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Peripheral NeuropathyNCT05262946

Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

A study testing sensorimotor training based on Feldenkrais method and foot care education in people with Peripheral Neuropathy and Somatosensory Disorders, run by Universidad Complutense de Madrid.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
sensorimotor training based on Feldenkrais method and foot care education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 30 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Exclusion Criteria: amputation and cognitive or mental issues

-

About this study

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

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.

Read the 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.

Being tested
sensorimotor training based on Feldenkrais method, foot care education, usual care
Keywords
gait, diabetes, sensorimotor training, peripheral neuropathy, somatosensory system, postural control, quality of life, fear of falling, Feldenkrais method
Medical subject headings
Peripheral Nervous System Diseases, Somatosensory Disorders, Gait Disorders, Neurologic, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sensorimotor training based on Feldenkrais methodBehavioural

    8 weeks of balance and sensorimotor training twice a week

  • foot care educationBehavioural

    Recommendations for preventing foot ulcers

  • usual careCombination product

    drugs and diet usual care

Study groups in NCT05262946
Study groupRoleWhat they receive
controlActive comparatorcontrol arm: usual care and foot care education.
Receives: Behavioral: foot care education; Combination Product: usual care
experimentalExperimentalexperimental arm: sensorimotor training, foot care education and usual care
Receives: Behavioral: sensorimotor training based on Feldenkrais method; Behavioral: foot care education; Combination Product: usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (6)

  1. Up and Go test

    postural control test

    Measured: 2 years

  2. Four Square Step test

    ability walking in different directions

    Measured: 2 years

  3. Tinetti- Performance-Oriented Mobility Assessment (POMA-T)

    static and dynamic postural control

    Measured: 2 years

  4. Falls Efficacy Scale

    It measures the fear of falling, ranging from 0 to 64, being higher scores worst outcome results

    Measured: 2 years

  5. SF-36 Health Survey questionnaire , 1.4 version.

    Quality of life health-related questionnaire

    Measured: 2 years

  6. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start1 Jan 2016
  3. Primary completion22 Dec 2019
  4. Study completion30 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 arms and single blinded randomized controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262946
Sponsor's protocol ID
DiabetesBalanceOne
Status last verified
Mar 2021
First submitted
31 Jan 2022
Last updated
4 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39593566

Questions about this trial

What is this clinical trial studying?

A study testing sensorimotor training based on Feldenkrais method and foot care education in people with Peripheral Neuropathy and Somatosensory Disorders, run by Universidad Complutense de Madrid.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Somatosensory Impairment Index (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05262946, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.

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