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临床试验/NCT06615089
NCT06615089尚未招募不适用

Effect Of Balance Training With Foot Orthosis On Falling In Elderly

Cairo University0 个研究点目标入组 60 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
balance

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

opaque sealed envelope

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

balance

时间窗: up to four months

The Berg Balance Scale (BBS) will be used to assess balance. it measure the ability of a subject to maintain balance while performing 14 movements required in everyday activities . Scoring is based on an ordinal 5-point scale of 0 to 4. A score of 0 is given if the subject is unable to complete the task and a 4 is given if the subject is able to complete the task unassisted. The maximum possible score is 56

次要结局

  • gait assessment(up to four months)
  • balance deficit(up to four months)
  • gait and balance assessment(up to four months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Youmn Nabil Saad Zaghloul Hafez

principal investigator youmn nabil saad zaghloul

Cairo University

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