Effect Of Balance Training With Foot Orthosis On Falling In Elderly

NCT06615089 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/004445
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Elderly

Keywords

balance trainig; foot orthosis; elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• gait assessment

  up to four months

• balance deficit

  up to four months

• gait and balance assessment

  up to four months

Study Arms (2)

balance training

EXPERIMENTAL

thirty elderly patients will receive balance training and orthotic prescription for four months

Other: balance training; Other: orthotic prescription

orthotic prescription

ACTIVE COMPARATOR

thirty elderly patients will receive orthotic prescription for four months

Other: orthotic prescription

Interventions

balance training OTHER

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

balance training

orthotic prescription OTHER

the elderly patients will receive Insoles inside the subjects' own regular shoes

balance training; orthotic prescription

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

youmn N saad zaghloul, master

CONTACT

01025354831; youmnhafez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: opaque sealed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator youmn nabil saad zaghloul

Model Details: balance training and foot orthosis

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09