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Foot Orthoses and Elderly Women With Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ibsen Coimbra, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01508169
First received: January 6, 2012
Last updated: March 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention
Osteoporosis
 Device: Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Foot Orthoses on the Balance of Elderly Women With Osteoporosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Berg Balance Scale (BBS) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Numeric Pain Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain)

  • Manchester Foot and Pain Disability Index(MFPDI) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 94
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Device: 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.
Other Name: Orthotics Unit of the Clinical Hospital of UNICAMP.
No Intervention: 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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • inability to attend the necessary reevaluations and/or to follow instructions and procedures of the research protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508169

Locations
Brazil
Clinical Hospital of The State University of Campinas
Campinas, São Paulo, Brazil
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Study Director: Eduardo P Magalhaes, MD, PhD University of Campinas, Brazil
Study Director: Ibsen B Coimbra, MD,PhD University of Campinas, Brazil
Study Director: Michael Davitt University of Campinas, Brazil
Principal Investigator: Cecília M Barbosa, MSc University of Campinas, Brazil
Study Director: João Francisco Marques-Neto, MD,PhD University of Campinas, Brazil
Study Chair: Manoel B Bértolo, MD,PhD University of Campinas, Brazil
  More Information

Publications:

Responsible Party: Ibsen Coimbra, Director of Medical Department of The Faculty of Medical Sciences, State University of Campinas (Unicamp), Brazil, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01508169     History of Changes
Other Study ID Numbers: UNICAMP-REUMATO 01
Study First Received: January 6, 2012
Results First Received: February 2, 2012
Last Updated: March 9, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
elderly
balance
insole
foot orthosis
orthotics

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013