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Completed

NCT Number: NCT01508169

Foot Orthoses and Elderly Women With Osteoporosis

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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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital of The State University of Campinas

Campinas, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Orthotics Unit of the Clinical Hospital of UNICAMP.

Primary outcomes

  1. 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.

  2. 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

  1. Numeric Pain Scale

    Time frame: 4 weeks

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

  2. Manchester Foot and Pain Disability Index(MFPDI)

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2012
Registry last updated
Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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