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Enrolling by invitation NCT06904417

Effect of Feldenkrais Method in Enhancing Postural Control for Patients with Diabetic Polyneuropathy

Phase I Interventional Diabetic Polyneuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Feldenkrais-based intervention, conventional balance training program.
Who it may be relevant to
Registry conditions: Diabetic Polyneuropathy. Basic parameters: 45 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of the Feldenkrais Method on Enhancing Postural Control in Patients with Diabetic Polyneuropathy

Overview

Background: Postural Control is a major complication of polyneuropathy, affecting patients suffering from diabetes mellitus. Purpose: To examine the effect of the Feldenkrais Method on dynamic balance, limits of stability and fear of falling in adults aged 45 to 60 years with diabetic polyneuropathy in the short and mid-term. Methods: A single-blinded, parallel, multicentric randomized control trial was conducted in two health centers. Adults aged 45 to 60 years with diabetic polyneuropathy and a history of falls or dynamic balance dysfunction were recruited from hospital databases and randomly assigned to either the study or control group. The study group received 16 sessions of Feldenkrais-based sensorimotor training. Both groups received diabetic foot care instructions and traditional balance exercises. Outcomes were measured at 3 and 6-month follow-up intervals. Dynamic balance was assessed using the Timed Up and Go (TUG) Test, limits of stability using Biodex and fear of falling with the Falls Efficacy Scale (FES).

Interventions

  • Other The Feldenkrais-based intervention
    The Feldenkrais-based intervention consisted of guided awareness exercises aimed at improving movement patterns, proprioception, and postural control. Sessions were conducted twice weekly for 12 weeks, with each session lasting approximately 45 minutes
  • Other conventional balance training program
    a conventional balance training program consisting of static and dynamic balance exercises, gait training, and strength-building activities, matched for session frequency and duration

Primary outcome measures

  • Dynamic Balance [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Postural Control [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Fear of Falling [Time frame: From enrollment to the end of treatment at 12 weeks]

Eligibility criteria

Inclusion criteria

  • Individuals must have a diagnosis of Diabetic Polyneuropathy (DPN), confirmed by clinical examination and electrophysiological testing.
  • Participants must have stable glycemic control for at least three months prior to enrollment.
  • Individuals must be able to walk independently, with or without the use of an assistive device.

Exclusion criteria

  • Individuals with severe visual or vestibular impairments are excluded from participation.
  • Participants with significant musculoskeletal disorders affecting gait are not eligible.
  • Individuals with severe cardiovascular or respiratory conditions are excluded.
  • Participants with cognitive impairments that prevent active participation are not eligible.
  • Individuals currently engaged in structured physical therapy or balance training programs are excluded.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT06904417 · P.T.REC/012/005646

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗