Effect Of Balance Training With Foot Orthosis On Falling In Elderly (FO)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Elderly
• Intervention / Treatment: Other: balance training; Other: orthotic prescription

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: youmn N saad zaghloul, master; Phone Number: 01025354831; Email: youmnhafez@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: balance training; thirty elderly patients will receive balance training and orthotic prescription for four months	Other: 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; Other: orthotic prescription; the elderly patients will receive Insoles inside the subjects' own regular shoes
Active Comparator: orthotic prescription; thirty elderly patients will receive orthotic prescription for four months	Other: orthotic prescription; the elderly patients will receive Insoles inside the subjects' own regular shoes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
balance	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	up to four months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gait assessment	The Dynamic gait index was primarily developed to assess a subject's ability to modify gait in response to changing task demands.The eight abilities assessed are: steady-state walking, walking while changing gait speed, walking while moving the head vertically and horizontally, walking while stepping over and around an obstacle, pivoting during walking, and stair climbing. The items of the DGI are graded on a four-point scale from 'normal performance' (3) to 'severely impaired' (0), yielding a maximum score of 24 points	up to four months
balance deficit	The Timed "up and go" test is performed in the following way. The patient will sit on a standard arm chair (seat height 46cm as in the original setting, arm height 67cm) with his or her back against the chair, arms resting on the chair's arms and walking aid at hand. Patients will wear their regular footwear and will use their customary walking aids. After the patient will state that he or she is ready, the test will start. On the word "go" the patient will stand, will walk to a line on the floor 3m away (on a standard short-piled carpet with a length of 4m and width of lm), turns, will walk back to the chair, and will sit down again.	up to four months
gait and balance assessment	The Tinetti Assessment Tool is a simple test that measures a participant's gait and balance. The participant performs a total of 16 tasks (during 9 tests the researcher assesses the balance of the participant and during 7 subsequent tests the researcher assesses the gait of the participant). Scoring of the Tinetti Assessment Tool is done on a two or 3-point ordinal scale (depending on the task) with a range of 0 to 1 or 0 to 2. A score of 0 represents the most impairment, while a score of 1 or 2 represents independence	up to four months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: elderly; foot orthosis; balance trainig
• Other Study ID Numbers: P.T.REC/012/004445

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No