Foot Orthoses and Elderly Women With Osteoporosis
|ClinicalTrials.gov Identifier: NCT01508169|
Recruitment Status : Completed
First Posted : January 11, 2012
Results First Posted : April 6, 2012
Last Update Posted : April 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Device: Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Foot Orthoses on the Balance of Elderly Women With Osteoporosis|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508169
|Clinical Hospital of The State University of Campinas|
|Campinas, São Paulo, Brazil|
|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|