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Clinical Trials/NCT06615089
NCT06615089
Not Yet Recruiting
N/A

Effect Of Balance Training With Foot Orthosis On Falling In Elderly

Cairo University0 sites60 target enrollmentOctober 1, 2024
ConditionsElderly

Overview

Phase
N/A
Intervention
Not specified
Conditions
Elderly
Sponsor
Cairo University
Enrollment
60
Primary Endpoint
balance
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
February 28, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Youmn Nabil Saad Zaghloul Hafez

principal investigator youmn nabil saad zaghloul

Cairo University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

balance

Time Frame: 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

Secondary Outcomes

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

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