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

Effect of the Feldenkrais Method on Enhancing Postural Control in 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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetic Polyneuropathy
• Intervention / Treatment: Other: The Feldenkrais-based intervention; Other: conventional balance training program

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Feldenkrais-based intervention; this group recieve The Feldenkrais-based intervention consisted of guided awareness exercises	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
Active Comparator: a conventional balance training program; The control group participated in a conventional balance training program consisting of static and dynamic balance exercises, gait training, and strength-building activities, matched for session frequency and duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Balance	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.	From enrollment to the end of treatment at 12 weeks
Postural Control	Evaluated using the Biodex Balance System, which measures limits of stability and sway index	From enrollment to the end of treatment at 12 weeks
Fear of Falling	Assessed using the Falls Efficacy Scale, a self-reported measure of confidence in performing daily activities without falling.	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2025
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Diabetic Polyneuropathy; Feldenkrais Method; Postural Control
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Complications; Polyneuropathies; Diabetic Neuropathies
• Other Study ID Numbers: P.T.REC/012/005646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No