NCT01508169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
3 months until next milestone

Results Posted

Study results publicly available

April 6, 2012

Completed
Last Updated

April 6, 2012

Status Verified

February 1, 2012

Enrollment Period

6 months

First QC Date

January 6, 2012

Results QC Date

February 2, 2012

Last Update Submit

March 9, 2012

Conditions

Osteoporosis

Keywords

elderlybalanceinsolefoot orthosisorthotics

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 weeks

Secondary Outcomes (2)

  • Numeric Pain Scale

    4 weeks

  • Manchester Foot and Pain Disability Index(MFPDI)

    4 weeks

Study Arms (2)

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.

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.

Interventions

Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)DEVICE

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.

Also known as: Orthotics Unit of the Clinical Hospital of UNICAMP.
Foot orthosis

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of osteoporosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital of The State University of Campinas

Campinas, São Paulo, Brazil

Location

Related Publications (10)

  • 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.

    PMID: 15029466BACKGROUND

  • 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.

    PMID: 15501837BACKGROUND

  • 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.

    PMID: 21120434BACKGROUND

  • 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.

    PMID: 19225271BACKGROUND

  • 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.

    PMID: 18684409BACKGROUND

  • 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.

    PMID: 21450692BACKGROUND

  • 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.

    PMID: 19424873BACKGROUND

  • 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.

    PMID: 19824780BACKGROUND

  • 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.

    PMID: 14550702BACKGROUND

  • 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.

    PMID: 17267222BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Results Point of Contact

Title
Cecilia de Morais Barbosa
Organization
Hospital de Clinicas da Universidade Estadual de Campinas (Unicamp)
cecimbarbosa@gmail.com
+55-19-35217113

Study Officials

  • 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

    STUDY DIRECTOR

  • Cecília M Barbosa, MSc

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

  • João Francisco Marques-Neto, MD,PhD

    University of Campinas, Brazil

    STUDY DIRECTOR

  • Manoel B Bértolo, MD,PhD

    University of Campinas, Brazil

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Medical Department of The Faculty of Medical Sciences, State University of Campinas (Unicamp), Brazil

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 11, 2012

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

April 6, 2012

Results First Posted

April 6, 2012

Record last verified: 2012-02

Locations

BR(1)