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

Phase 1

• Conditions: Diabetic Polyneuropathy

• Registration Number: NCT06904417
• Lead Sponsor: Cairo University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study Start: 2025-03-30
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dynamic Balance	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.
Postural Control	From enrollment to the end of treatment at 12 weeks	Evaluated using the Biodex Balance System, which measures limits of stability and sway index
Fear of Falling	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt