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Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Completed
CT.gov ID
NCT04620993
Collaborator
(none)
73
Enrollment
1
Location
4.6
Actual Duration (Months)
15.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia
  • Other: Evaluation of navıcular drop
  • Other: Evaluation of plantar pressure distrubution

Study Design

Study Type:
Observational
Actual Enrollment :
73 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
Actual Study Start Date :
Jan 2, 2021
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 23, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Evaluation of biomechanical and viscoelastic properties of plantar fascia [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 [Baseline Measurements]

    Measuring of plantar pressure distrubution (with Tekscan, Boston, MA, USA) in free standing position

Secondary Outcome Measures

  1. Evaluation of navicular drop [Baseline Measurements]

    Measuring of the amount of the navicular drop

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Istanbul Saglık Bilimleri University Istanbul Turkey

Sponsors and Collaborators

  • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier:
NCT04620993
Other Study ID Numbers:
  • 166
First Posted:
Nov 9, 2020
Last Update Posted:
Jan 20, 2022
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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:
Pelvic Girdle Pain

Study Results

No Results Posted as of Jan 20, 2022