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Набор по приглашению NCT06904417

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

Фаза I С лечением Diabetic Polyneuropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The Feldenkrais-based intervention, conventional balance training program.
Кому может быть актуально
Состояния в реестре: Diabetic Polyneuropathy. Базовые параметры: 45 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

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

Обзор

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).

Вмешательства

  • Другое 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
  • Другое 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

Первичные конечные точки

  • Dynamic Balance [Срок оценки: From enrollment to the end of treatment at 12 weeks]
  • Postural Control [Срок оценки: From enrollment to the end of treatment at 12 weeks]
  • Fear of Falling [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Cairo University — Cairo

Идентификаторы

NCT: NCT06904417 · P.T.REC/012/005646

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗