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

NCT06904417 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: P.T.REC/012/005646
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Polyneuropathy

Keywords

Feldenkrais Method; Postural Control; Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

The Feldenkrais-based intervention

EXPERIMENTAL

this group recieve The Feldenkrais-based intervention consisted of guided awareness exercises

Other: The Feldenkrais-based intervention

a conventional balance training program

ACTIVE COMPARATOR

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

Interventions

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

The Feldenkrais-based intervention

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

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: April 1, 2025
• Study Start: March 30, 2025
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)