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

NCT ID: NCT06904417

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-30
• Study Completion Date: 2025-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The Feldenkrais-based intervention

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

Group Type: EXPERIMENTAL

The Feldenkrais-based intervention

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

No interventions assigned to this group

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Islam Hassan Fayed

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/005646

Identifier Type: -

Identifier Source: org_study_id