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Clinical Trials/NCT01508169
NCT01508169
Completed
N/A

The Effect of Foot Orthoses on the Balance of Elderly Women With Osteoporosis

University of Campinas, Brazil1 site in 1 country94 target enrollmentApril 2011
ConditionsOsteoporosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
University of Campinas, Brazil
Enrollment
94
Locations
1
Primary Endpoint
Berg Balance Scale (BBS)
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The objective of this study was to determine if foot orthoses are effective in improving balance, pain and disability in elderly women with osteoporosis.

Detailed Description

Aging has been associated with balance impairment. The use of foot orthoses has been shown to be a feasible strategy for improving postural control.The objective of this study was to determine if foot orthoses (with metatarsal pad and medial arch support) are effective as an adjuvant treatment to improve balance, foot pain and disability in elderly women with osteoporosis. Another purpose was to verify if social demographic and clinical factors such as age, race, education, marital status, age of menopause, use of drugs related to balance dysfunction, visual or hearing complaints, body mass index, previous fractures and number of falls may influence the results.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
October 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University of Campinas, Brazil
Responsible Party
Principal Investigator
Principal Investigator

Ibsen Coimbra

Director of Medical Department of The Faculty of Medical Sciences, State University of Campinas (Unicamp), Brazil

University of Campinas, Brazil

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of osteoporosis

Exclusion Criteria

  • reduced tactile and thermal foot sensibility
  • compromised skin integrity of the lower limbs
  • autoimmune rheumatic diseases
  • vestibular symptoms
  • central nervous system pathologies
  • peripheral neuropathy
  • use of insoles in the last month
  • lower limb prostheses
  • previous history of foot surgery
  • amputation of the lower limbs

Outcomes

Primary Outcomes

Berg Balance Scale (BBS)

Time Frame: 4 weeks

The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking.

Timed up and Go Test (TUG)

Time Frame: 4 weeks

The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair.

Secondary Outcomes

  • Numeric Pain Scale(4 weeks)
  • Manchester Foot and Pain Disability Index(MFPDI)(4 weeks)

Study Sites (1)

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