The objective of this study was to determine if foot orthoses are effective in improving balance, pain and disability in elderly women with osteoporosis.
Full Title of Study: “The Effect of Foot Orthoses on the Balance of Elderly Women With Osteoporosis”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: October 2011
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.
- 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.
Arms, Groups and Cohorts
- 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.
- 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.
Clinical Trial Outcome Measures
- 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.
- 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)
- 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.
Participating in This Clinical Trial
- Clinical diagnosis of osteoporosis
- 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
Gender Eligibility: Female
Minimum Age: 60 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Campinas, Brazil
- Provider of Information About this Clinical Study
- Principal Investigator: Ibsen Coimbra, Director of Medical Department of The Faculty of Medical Sciences, State University of Campinas (Unicamp), Brazil – University of Campinas, Brazil
- Overall Official(s)
- Eduardo P Magalhaes, MD, PhD, Study Director, University of Campinas, Brazil
- Ibsen B Coimbra, MD,PhD, Study Director, University of Campinas, Brazil
- Michael Davitt, Study Director, University of Campinas, Brazil
- Cecília M Barbosa, MSc, Principal Investigator, University of Campinas, Brazil
- João Francisco Marques-Neto, MD,PhD, Study Director, University of Campinas, Brazil
- Manoel B Bértolo, MD,PhD, Study Chair, University of Campinas, Brazil
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