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Foot Orthoses and Elderly Women With Osteoporosis

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring elderly, balance, insole, foot orthosis, orthotics

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Hospital of The State University of Campinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Foot orthosis

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Berg Balance Scale (BBS)
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)
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
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)
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.

Full Information

First Posted
January 6, 2012
Last Updated
March 9, 2012
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01508169
Brief Title
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

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
elderly, balance, insole, foot orthosis, orthotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foot orthosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)
Other Intervention Name(s)
Orthotics Unit of the Clinical Hospital of UNICAMP.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
Description
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.
Time Frame
4 weeks
Title
Timed up and Go Test (TUG)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Scale
Description
Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain)
Time Frame
4 weeks
Title
Manchester Foot and Pain Disability Index(MFPDI)
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo P Magalhaes, MD, PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ibsen B Coimbra, MD,PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Davitt
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cecília M Barbosa, MSc
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
João Francisco Marques-Neto, MD,PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manoel B Bértolo, MD,PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Hospital of The State University of Campinas
City
Campinas
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
15029466
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.
Results Reference
background
PubMed Identifier
15501837
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.
Results Reference
background
PubMed Identifier
21120434
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.
Results Reference
background
PubMed Identifier
19225271
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.
Results Reference
background
PubMed Identifier
18684409
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.
Results Reference
background
PubMed Identifier
21450692
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.
Results Reference
background
PubMed Identifier
19424873
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.
Results Reference
background
PubMed Identifier
19824780
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.
Results Reference
background
PubMed Identifier
14550702
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.
Results Reference
background
PubMed Identifier
17267222
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.
Results Reference
background

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Foot Orthoses and Elderly Women With Osteoporosis

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