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Набор скоро начнётся NCT06615089

Effect Of Balance Training With Foot Orthosis On Falling In Elderly

Без фазы С лечением Elderly

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: balance training, orthotic prescription.
Кому может быть актуально
Состояния в реестре: Elderly. Базовые параметры: 65 лет — 75 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

this study will be conducted to investigate effect of balance training with foot orthosis on falling in elderly.

Подробное описание

The concept of physiology of ageing implies that a series of complex events occur which ultimately lead to a progressive reduction in function of all organ systems. This process, also called "homeostenosis," is influenced by gene variations and differences in exposure to environmental factors .Reduction in muscle strength and coordination of the lower extremities accompanied by decreased gait assurance and balance control are the result of a physical deterioration in an older body. Together with decreased cognitive functions, these impairments lead to a higher risk of falling among the elderly. The foot is the first point of contact between the body and the external environment, and it plays an important role in postural sway. Its plantar mechanical receptors provide spatial and temporal information about contact pressures and shear forces resulting from body movement being a valuable feedback mechanism to the postural control system. Interventions to optimize sensory information from plantar sole such as vibration stimuli, customized foot orthoses, textured insoles, and sandals with textured insoles and magnetic insoles have been tested before, some of them showing balance improvement .Sixty elderly patients will be allocated randomly to two groups; group 1 will receive balance training program beside orthotic prescription and group 2 will receive orthotic prescription alone.

Вмешательства

  • Другое balance training
    the elderly patients will receive balance training in the form of proprioceptive and vestibular training components. proprioceptive training include Standing static balance, lateral weight transfer, Lateral weight transfer near to chair, tandem closed eyes, walking on toes, Postural control using ball. Vestibular training in the form of Balance with head movement, seated lateral step in addition to Insoles inside the subjects' own regular shoes
  • Другое orthotic prescription
    the elderly patients will receive Insoles inside the subjects' own regular shoes

Первичные конечные точки

  • balance [Срок оценки: up to four months]
Вторичные конечные точки (3)
  • gait assessment [Срок оценки: up to four months]
  • balance deficit [Срок оценки: up to four months]
  • gait and balance assessment [Срок оценки: up to four months]

Критерии участия

Критерии включения

  • Age 65-75years
  • Both gender
  • Body mass index 25-29.9 kg/m2
  • All participants will use foot orthosis
  • Clinically and medically stable patients
  • having a Berg Balance Scale (BBS) score between 35 and 45
  • Scored 19-21 will be regarded as being at moderate risk of falling,
  • Scored 19-23 in the Tinetti tool score
  • Scored more than 13.5 sec in timed up-and-go test

Критерии исключения

  • Bedridden subjects.
  • Previous vestibular diseases, central nervous system pathologies (such as stroke, dementia, Parkinson, etc.).
  • Previous diagnosis of peripheral neuropathy.
  • current use of medications affect the result of the study
  • Use of insoles in the last month
  • Previous history of foot surgery, and amputation of the lower limbs.
  • severe foot deformity (not able to wear regular shoes), difficulty in adapting insoles inside his/her own shoes,
  • Patient with life threatening disorders as renal failure, myocardial infarction.
  • Patients who suffering from myasthenia gravis, hyperthyroidism, haemorrhage, acute viral disease, acute tuberculosis, mental disorders or those with pacemakers.
  • Un controlled diabetes, hypertension and smokers

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06615089 · P.T.REC/012/004445

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗