Clinical trial NCT01508169: Foot Orthoses and Elderly Women With Osteoporosis
Official title: The Effect of Foot Orthoses on the Balance of Elderly Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: elderly
balance
insole
foot orthosis
orthotics
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 94
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 4 weeks
measure: Timed up and Go Test (TUG)
timeFrame: 4 weeks
Secondary outcomes:
measure: Numeric Pain Scale
timeFrame: 4 weeks
measure: Manchester Foot and Pain Disability Index(MFPDI)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Clinical Hospital of The State University of Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Eduardo P Magalhaes, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Campinas, Brazil
name: Ibsen B Coimbra, MD,PhD
role: STUDY_DIRECTOR
affiliation: University of Campinas, Brazil
name: Michael Davitt
role: STUDY_DIRECTOR
affiliation: University of Campinas, Brazil
name: Cecília M Barbosa, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campinas, Brazil
name: João Francisco Marques-Neto, MD,PhD
role: STUDY_DIRECTOR
affiliation: University of Campinas, Brazil
name: Manoel B Bértolo, MD,PhD
role: STUDY_CHAIR
References:
citation: Meyer PF, Oddsson LI, De Luca CJ. Reduced plantar sensitivity alters postural responses to lateral perturbations of balance. Exp Brain Res. 2004 Aug;157(4):526-36. doi: 10.1007/s00221-004-1868-3. Epub 2004 Mar 17.
citation: Melzer I, Benjuya N, Kaplanski J. Postural stability in the elderly: a comparison between fallers and non-fallers. Age Ageing. 2004 Nov;33(6):602-7. doi: 10.1093/ageing/afh218.
citation: Burke TN, Franca FJ, Meneses SR, Cardoso VI, Pereira RM, Danilevicius CF, Marques AP. Postural control among elderly women with and without osteoporosis: is there a difference? Sao Paulo Med J. 2010 Jul;128(4):219-24. doi: 10.1590/s1516-31802010000400009.
citation: Bernard-Demanze L, Vuillerme N, Ferry M, Berger L. Can tactile plantar stimulation improve postural control of persons with superficial plantar sensory deficit? Aging Clin Exp Res. 2009 Feb;21(1):62-8. doi: 10.1007/BF03324900.
citation: Mulford D, Taggart HM, Nivens A, Payrie C. Arch support use for improving balance and reducing pain in older adults. Appl Nurs Res. 2008 Aug;21(3):153-8. doi: 10.1016/j.apnr.2006.08.006.
citation: Hatton AL, Dixon J, Rome K, Martin D. Standing on textured surfaces: effects on standing balance in healthy older adults. Age Ageing. 2011 May;40(3):363-8. doi: 10.1093/ageing/afr026. Epub 2011 Mar 29.
citation: Palluel E, Nougier V, Olivier I. Do spike insoles enhance postural stability and plantar-surface cutaneous sensitivity in the elderly? Age (Dordr). 2008 Mar;30(1):53-61. doi: 10.1007/s11357-008-9047-2. Epub 2008 Mar 4.
citation: Palluel E, Olivier I, Nougier V. The lasting effects of spike insoles on postural control in the elderly. Behav Neurosci. 2009 Oct;123(5):1141-7. doi: 10.1037/a0017115.
citation: Priplata AA, Niemi JB, Harry JD, Lipsitz LA, Collins JJ. Vibrating insoles and balance control in elderly people. Lancet. 2003 Oct 4;362(9390):1123-4. doi: 10.1016/S0140-6736(03)14470-4.
citation: Wilson ML, Rome K, Hodgson D, Ball P. Effect of textured foot orthotics on static and dynamic postural stability in middle-aged females. Gait Posture. 2008 Jan;27(1):36-42. doi: 10.1016/j.gaitpost.2006.12.006. Epub 2007 Jan 30.