Clinical trial NCT06615089: Effect Of Balance Training With Foot Orthosis On Falling In Elderly
Official title: Effect Of Balance Training With Foot Orthosis On Falling In Elderly
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elderly
Keywords: balance trainig
foot orthosis
elderly
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: balance training and foot orthosis
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: balance
timeFrame: up to four months
Secondary outcomes:
measure: gait assessment
timeFrame: up to four months
measure: balance deficit
timeFrame: up to four months
measure: gait and balance assessment
timeFrame: up to four months
Other outcomes:
Locations:
Study officials:
References: