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NCT Number: NCT06904417

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

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).

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Key information

Conditions

Diabetic Polyneuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cairo University

Cairo, Cairo Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Feldenkrais-based intervention

Other

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

conventional balance training program

Other

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 outcomes

  1. Dynamic Balance

    Time frame: From enrollment to the end of treatment at 12 weeks

    Assessed using the Timed Up and Go Test, which measures the time taken to stand from a seated position, walk three meters, turn around, walk back, and sit down.

  2. Postural Control

    Time frame: From enrollment to the end of treatment at 12 weeks

    Evaluated using the Biodex Balance System, which measures limits of stability and sway index

  3. Fear of Falling

    Time frame: From enrollment to the end of treatment at 12 weeks

    Assessed using the Falls Efficacy Scale, a self-reported measure of confidence in performing daily activities without falling.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: FeM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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