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Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women

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ClinicalTrials.gov Identifier: NCT04620993
Recruitment Status : Not yet recruiting
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Pelvic Girdle Pain Biomechanical and Viscoelastic Properties of Plantar Fascia Pregnant Woman Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia Other: Evaluation of navıcular drop Other: Evaluation of plantar pressure distrubution

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Investigation of the Effect of Biomechanical and Viscoelastic Properties of Plantar Fascia on Pelvic Girdle Pain in Pregnant Women
Estimated Study Start Date : November 2, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : June 1, 2021
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Evaluation of plantar pressure distrubution [ Time Frame: Baseline Measurements ]
    Measuring of plantar pressure distrubution (with Tekscan, Boston, MA, USA) in free standing position


Secondary Outcome Measures :
  1. Evaluation of navicular drop [ Time Frame: Baseline Measurements ]
    Measuring of the amount of the navicular drop


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant healthy women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant healthy women
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620993


Locations
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Turkey
Istanbul Saglık Bilimleri University
Istanbul, Turkey
Contact: Nilufer KABLAN, PHD    05067638556    niluferkablan@yahoo.com   
Contact: Merve CAN, Msc    05388397713    mervecaann@gmail.com   
Sponsors and Collaborators
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier: NCT04620993    
Other Study ID Numbers: 166
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey:
pelvic girdle pain, pregnant women, plantar fascia
Additional relevant MeSH terms:
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Pelvic Girdle Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Pelvic Pain