Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women

January 19, 2022 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigation of the Effect of Biomechanical and Viscoelastic Properties of Plantar Fascia on Pelvic Girdle Pain in Pregnant Women

Pelvic girdle pain is frequently experienced in pregnant women and the mechanism of pelvic girdle pain is not known exactly. The aim of this study is to investigate the effect of biomechanical and viscoelastic properties of plantar fascia on pelvic girdle pain in pregnant women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Saglık Bilimleri University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant healthy women

Description

Inclusion Criteria:

  • Pregnant women in the 2nd or 3rd trimester of pregnancy with pelvic girdle pain
  • Pregnant women in the 2nd or 3rd trimester of pregnancy without pelvic girdle pain
  • First pregnancy
  • 20-40 years old
  • Healthy woman without pregnancy

Exclusion Criteria:

  • Participant having any kind of connective tissue disease
  • Presence of orthopedic or neurological problems in the lower extremities that may cause musculoskeletal disorder and biomechanical alignment deviations
  • Presence of foot pain that started before pregnancy and lasts for more than 3 months
  • Presence of lumbar-pelvic pain that started before pregnancy and lasts for more than 3 months
  • Have had 2 or more births
  • Presence of multiple pregnancy (twins, triplets etc)
  • Presence of ankle-ankle fracture and operation history in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: pregnant women with pelvic girdle pain
This group will consist of pregnant women who are in the 2nd or 3rd trimester of pregnancy and have pelvic girdle pain.
Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia

The biomechanical and viscoelastic properties of the plantar fascia will be measured in the side lying position.

Measurements will be made with the ankle in neutral position and maximum dorsi flexion position.

Other: Evaluation of navıcular drop
The amount of navicular drop of both feet will be measured
Other: Evaluation of plantar pressure distrubution
The distribution of foot plantar pressure and the amount of change in the center of gravity will be measured in the free standing position.
Group 2:pregnant women without pelvic girdle pain
This group will consist of pregnant women who are in the 2nd or 3rd trimester of pregnancy but have not pelvic girdle pain.
Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia

The biomechanical and viscoelastic properties of the plantar fascia will be measured in the side lying position.

Measurements will be made with the ankle in neutral position and maximum dorsi flexion position.

Other: Evaluation of navıcular drop
The amount of navicular drop of both feet will be measured
Other: Evaluation of plantar pressure distrubution
The distribution of foot plantar pressure and the amount of change in the center of gravity will be measured in the free standing position.
Group 3: healthy women
This group will consist of healthy women who have not been pregnant.
Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia

The biomechanical and viscoelastic properties of the plantar fascia will be measured in the side lying position.

Measurements will be made with the ankle in neutral position and maximum dorsi flexion position.

Other: Evaluation of navıcular drop
The amount of navicular drop of both feet will be measured
Other: Evaluation of plantar pressure distrubution
The distribution of foot plantar pressure and the amount of change in the center of gravity will be measured in the free standing position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of biomechanical and viscoelastic properties of plantar fascia
Time Frame: Baseline Measurements
Measuring of the biomechanical and viscoelastic properties of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.
Baseline Measurements
Evaluation of plantar pressure distrubution
Time Frame: Baseline Measurements
Measuring of plantar pressure distrubution (with Tekscan, Boston, MA, USA) in free standing position
Baseline Measurements

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of navicular drop
Time Frame: Baseline Measurements
Measuring of the amount of the navicular drop
Baseline Measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2021

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 23, 2021

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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