N/A
N=94
Foot Orthoses and Elderly Women With Osteoporosis
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT01508169 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Berg Balance Scale (BBS) — 50.68; 43.13 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP) (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Female
- Sponsor
- University of Campinas, Brazil
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Berg Balance Scale (BBS) |
50.68; 43.13 | — |
| PRIMARY Timed up and Go Test (TUG) |
11.97; 15.82 | — |
| SECONDARY Numeric Pain Scale |
1.68; 4.20 | — |
| SECONDARY Manchester Foot and Pain Disability Index(MFPDI) |
11.48; 22.64 | — |
Summary
The objective of this study was to determine if foot orthoses are effective in improving balance, pain and disability in elderly women with osteoporosis.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01508169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.