Foot Orthoses and Elderly Women With Osteoporosis

University of Campinas, Brazil94 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Osteoporosis

Interventions

Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)DEVICE

Custom foot orthoses made of ethylene-vinyl acetate (EVA) with medial arch supports and metatarsal pads (supporting the diaphysis of the second to fourth metatarsals) that were manufactured by the Orthotics and Prostheses Unit of the Clinical Hospital of UNICAMP.

Eligibility

Sex: FEMALEMin age: 60 Years

Medical Language ↔ Plain English

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 * inability to attend the necessary reevaluations and/or to follow instructions and procedures of the research protocol

Locations (1)

Clinical Hospital of The State University of Campinas

Campinas, São Paulo, Brazil

Outcomes

Primary Outcomes

Berg Balance Scale (BBS)

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.

Time frame: 4 weeks

Timed up and Go Test (TUG)

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.

Time frame: 4 weeks

Secondary Outcomes

Numeric Pain Scale

Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain)

Time frame: 4 weeks

Manchester Foot and Pain Disability Index(MFPDI)

The MFPDI is a test used to assess disability related to foot pain in elderly. It consists of 19 statements prefaced by the phrase "Because of pain in my feet…", organized under three constructs: functional limitation (10 items), pain intensity (five items), and personal appearance (two items). For each statement, there are three possible answers: "none of the time" (score = 0), "some days" (score = 1), and "most days/every day" (score = 2). The final score is the sum of all the items and ranges from 0 to 38. The higher score, the greater disability.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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