NCT01989338

Brief Summary

To investigate relationship between HV deformity and position of rearfoot joints, and its effects on the quality of life, pain, and related functional status in women with bilateral hallux valgus (HV).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

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

March 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
Last Updated

November 21, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

October 11, 2013

Last Update Submit

November 14, 2013

Conditions

Keywords

hallux valguspainfunctional statusquality of life

Outcome Measures

Primary Outcomes (2)

  • Pain

    Pain was measured using by Visual Analog Scale

    baseline

  • AOFAS Mid foot (MF) Scales

    baseline

Secondary Outcomes (1)

  • HV angle and navicular height

    baseline

Other Outcomes (4)

  • Foot Function Index

    baseline

  • American Orthopaedic Foot and Ankle Society (AOFAS)MTP-IP

    baseline

  • weight-bearing and non-weight-bearing subtalar pronation (SP)

    baseline

  • +1 more other outcomes

Study Arms (1)

Hallux valgus patients

Females patients with hallux valgus asses for pain, function, and quality of life

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Effects of hallux valgus deformity in women

You may qualify if:

  • Women in an age range of 18-55 years,
  • Having bilateral deformity with right-dominance,
  • First MTP angle of \> 15° as radiologically determined by the referring physician,
  • Deformity intensity \> 2 based on the Manchester scale,
  • Muscle forces on ankle and foot \> 4
  • Having no systemic disease that affects foot biomechanics with no history of surgery,
  • Having no neurological problems,
  • Having no cognitive, mental, or psychological problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (44)

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    BACKGROUND
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    BACKGROUND
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    PMID: 17342454BACKGROUND
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    PMID: 21080349BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    PMID: 11266481BACKGROUND
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MeSH Terms

Conditions

Hallux ValgusPain

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Burcu TALU, PT. MSc

    İnönü University, School of Malatya Health, Department of Physiotherapy and Rehabilitation

    STUDY DIRECTOR
  • Gürsoy COŞKUN, PT. PhD.

    Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, TURKEY

    PRINCIPAL INVESTIGATOR
  • Nilgün BEK, PT. PhD.

    Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, TURKEY

    STUDY CHAIR
  • Kezban BAYRAMLAR, PT. PhD

    Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, TURKEY

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hacettepe University

Study Record Dates

First Submitted

October 11, 2013

First Posted

November 21, 2013

Study Start

March 1, 2012

Primary Completion

September 1, 2012

Study Completion

February 1, 2013

Last Updated

November 21, 2013

Record last verified: 2013-09