OsteoporosisNCT01508169

Foot Orthoses and Elderly Women With Osteoporosis

A study testing Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP) in people with Osteoporosis, run by University of Campinas, Brazil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 60 years and older, women only
Conditions the study is for: Osteoporosis
What is being tested?: Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 1 siteBrazil
Study dates: Apr 2011to Oct 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of osteoporosis

Who cannot join

reduced tactile and thermal foot sensibility
compromised skin integrity of the lower limbs
autoimmune rheumatic diseases
vestibular symptoms
central nervous system pathologies
peripheral neuropathy

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Clinical Hospital of The State University of Campinas
Campinas, São Paulo

Other trials in Brazil

About this study

Official title: The Effect of Foot Orthoses on the Balance of Elderly Women With Osteoporosis

The objective of this study was to determine if foot orthoses are effective in improving balance, pain and disability in elderly women with osteoporosis.

Read the 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.

Conditions: Osteoporosis
Being tested: Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)
Keywords: elderly, balance, insole, foot orthosis, orthotics
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)Device
Also called 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.

Study groups in NCT01508169
Study group	Role	What they receive
Foot orthosis	Experimental	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. Receives: Device: Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)
Control Group	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 weeks
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.
Measured: 4 weeks

Secondary outcomes (2)

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)
Measured: 4 weeks
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.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Oct 2011

First posted11 Jan 2012 (estimated)
Study startApr 2011
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01508169
Sponsor's protocol ID: UNICAMP-REUMATO 01
Status last verified: Feb 2012
First submitted: 6 Jan 2012
Last updated: 6 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 15029466
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.
PubMed 15501837
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.
PubMed 21120434
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.
PubMed 19225271
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.
PubMed 18684409
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.
PubMed 21450692
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.
PubMed 19424873
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.
PubMed 19824780
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.
PubMed 14550702
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.
PubMed 17267222

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Foot Orthoses on the Balance of Elderly Women With Osteoporosis
ClinicalTrials.gov ID: NCT01508169
Acronym / sponsor ID: UNICAMP-REUMATO 01
Conditions: Osteoporosis
Keywords: elderly, balance, insole, foot orthosis, orthotics
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: University of Campinas, BrazilUniversity, hospital or other
Study start: Apr 2011
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 11 Jan 2012 (estimated)
Results: Posted 6 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Foot orthosis	Experimental	Device: Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)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.
Control Group	No intervention	–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.

Who may qualify

Ages: 60 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Clinical diagnosis of osteoporosis

Key exclusion criteria (11 listed)

reduced tactile and thermal foot sensibility
compromised skin integrity of the lower limbs
autoimmune rheumatic diseases
vestibular symptoms
central nervous system pathologies

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)Also: 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.	Device	Foot orthosis

Primary outcome

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.

2 secondary outcomes

Numeric Pain Scale
Time frame: 4 weeks
Manchester Foot and Pain Disability Index(MFPDI)
Time frame: 4 weeks

Results and safety

Results posted to the registry on 6 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Foot Orthosis	47	44
Control Group	47	45

Primary outcome: Berg Balance Scale (BBS)

Time frame: 4 weeks. Mean (Standard Deviation). Unit: scores on a scale

Measure	Foot Orthosis n = 44	Control Group n = 45
Value	50.68 (4.18)	43.13 (6.24)

Population analysed: A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.

Primary outcome: Timed up and Go Test (TUG)

Time frame: 4 weeks. Mean (Standard Deviation). Unit: seconds

Measure	Foot Orthosis n = 44	Control Group n = 45
Value	11.97 (2.80)	15.82 (3.23)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The subjects from the foot orthoses group were asked to note and report the occurrence of any adverse effects during a four-week period.. Other adverse events reported at 4.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Foot Orthosis	0 of 47 (0%)	6 of 47 (12.8%)	Not reported
Control Group	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15029466Meyer 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.
Background: PubMed 15501837Melzer 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.
Background: PubMed 21120434Burke 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.
Background: PubMed 19225271Bernard-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.
Background: PubMed 18684409Mulford 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.
Background: PubMed 21450692Hatton 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.
Background: PubMed 19424873Palluel 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.
Background: PubMed 19824780Palluel 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.
Background: PubMed 14550702Priplata 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.
Background: PubMed 17267222Wilson 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.

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
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Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP) in people with Osteoporosis, run by University of Campinas, Brazil at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Scale (BBS) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01508169, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.