Clinical trial NCT06904417: Effect of Feldenkrais Method in Enhancing Postural Control for Patients with Diabetic Polyneuropathy
Official title: Effect of the Feldenkrais Method on Enhancing Postural Control in Patients with Diabetic Polyneuropathy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Diabetic Polyneuropathy
Keywords: Feldenkrais Method
Postural Control
Diabetic Polyneuropathy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Dynamic Balance
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Postural Control
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Fear of Falling
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: