Foot Orthoses and Elderly Women With Osteoporosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Foot orthosis

Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Control Group

Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type DEVICE

Other Intervention Names

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Orthotics Unit of the Clinical Hospital of UNICAMP.

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Ibsen Coimbra

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

Responsibility Role PRINCIPAL_INVESTIGATOR