Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women
Investigation of the Effect of Biomechanical and Viscoelastic Properties of Plantar Fascia on Pelvic Girdle Pain in Pregnant Women
1 other identifier
observational
73
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2020
CompletedFirst Posted
Study publicly available on registry
November 9, 2020
CompletedStudy Start
First participant enrolled
January 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2021
CompletedJanuary 20, 2022
November 1, 2020
4 months
November 3, 2020
January 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluation of biomechanical and viscoelastic properties of plantar fascia
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
Measuring of plantar pressure distrubution (with Tekscan, Boston, MA, USA) in free standing position
Baseline Measurements
Secondary Outcomes (1)
Evaluation of navicular drop
Baseline Measurements
Study Arms (3)
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.
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.
Group 3: healthy women
This group will consist of healthy women who have not been pregnant.
Interventions
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.
The amount of navicular drop of both feet will be measured
The distribution of foot plantar pressure and the amount of change in the center of gravity will be measured in the free standing position.
Eligibility Criteria
Pegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant healthy women
You may qualify if:
- 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
- years old
- Healthy woman without pregnancy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Saglık Bilimleri University
Istanbul, Turkey (Türkiye)
Related Publications (9)
Park SY, Park DJ. Comparison of Foot Structure, Function, Plantar Pressure and Balance Ability According to the Body Mass Index of Young Adults. Osong Public Health Res Perspect. 2019 Apr;10(2):102-107. doi: 10.24171/j.phrp.2019.10.2.09.
PMID: 31065537BACKGROUNDElden H, Gutke A, Kjellby-Wendt G, Fagevik-Olsen M, Ostgaard HC. Predictors and consequences of long-term pregnancy-related pelvic girdle pain: a longitudinal follow-up study. BMC Musculoskelet Disord. 2016 Jul 12;17:276. doi: 10.1186/s12891-016-1154-0.
PMID: 27406174RESULTBertuit J, Van Lint CE, Rooze M, Feipel V. Pregnancy and pelvic girdle pain: Analysis of pelvic belt on pain. J Clin Nurs. 2018 Jan;27(1-2):e129-e137. doi: 10.1111/jocn.13888. Epub 2017 Nov 3.
PMID: 28544276RESULTKerbourc'h F, Bertuit J, Feipel V, Rooze M. Pregnancy and Pelvic Girdle PainAnalysis of Center of Pressure During Gait. J Am Podiatr Med Assoc. 2017 Jul;107(4):299-306. doi: 10.7547/15-087.
PMID: 28880594RESULTAldabe D, Ribeiro DC, Milosavljevic S, Dawn Bussey M. Pregnancy-related pelvic girdle pain and its relationship with relaxin levels during pregnancy: a systematic review. Eur Spine J. 2012 Sep;21(9):1769-76. doi: 10.1007/s00586-012-2162-x. Epub 2012 Feb 4.
PMID: 22310881RESULTCeprnja D, Chipchase L, Gupta A. Prevalence of pregnancy-related pelvic girdle pain and associated factors in Australia: a cross-sectional study protocol. BMJ Open. 2017 Nov 15;7(11):e018334. doi: 10.1136/bmjopen-2017-018334.
PMID: 29146651RESULTWuytack F, Daly D, Curtis E, Begley C. Prognostic factors for pregnancy-related pelvic girdle pain, a systematic review. Midwifery. 2018 Nov;66:70-78. doi: 10.1016/j.midw.2018.07.012. Epub 2018 Aug 8.
PMID: 30142609RESULTAldabe D, Milosavljevic S, Bussey MD. Is pregnancy related pelvic girdle pain associated with altered kinematic, kinetic and motor control of the pelvis? A systematic review. Eur Spine J. 2012 Sep;21(9):1777-87. doi: 10.1007/s00586-012-2401-1. Epub 2012 Jun 21.
PMID: 22718046RESULTKhamis S, Yizhar Z. Effect of feet hyperpronation on pelvic alignment in a standing position. Gait Posture. 2007 Jan;25(1):127-34. doi: 10.1016/j.gaitpost.2006.02.005. Epub 2006 Apr 18.
PMID: 16621569RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2020
First Posted
November 9, 2020
Study Start
January 2, 2021
Primary Completion
May 1, 2021
Study Completion
May 23, 2021
Last Updated
January 20, 2022
Record last verified: 2020-11