Study of Changes in the Feet With Pregnancy
Enhancing Women's Health Through Assessing Foot Plasticity With Pregnancy
1 other identifier
interventional
72
1 country
1
Brief Summary
This research is being conducted to determine whether use of an arch-supporting insole during pregnancy prevents alterations in foot structure and lower limb rotational movements. The investigators hypothesize that the arch collapse during pregnancy will be significantly reduced in women randomized to use the supportive insole compared with women randomized to the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pregnancy
Started May 2013
Shorter than P25 for not_applicable pregnancy
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
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 23, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
August 2, 2016
CompletedAugust 2, 2016
June 1, 2016
4 months
May 23, 2013
June 10, 2015
June 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Arch Drop
Measurement of Arch Drop (Sitting arch height minus standing arch height) using Arch Height Index Measurement System
baseline, 8 weeks postpartum
Secondary Outcomes (2)
Change in Arch Rigidity
baseline, 8 weeks postpartum
Change in CPEI (3mph)
baseline, 8 weeks postpartum
Study Arms (2)
Usual
NO INTERVENTIONParticipants who are not randomized to the fitted insole intervention
Insole
EXPERIMENTALParticipants randomized to use of a custom-molded insole during pregnancy
Interventions
Eligibility Criteria
You may qualify if:
- Women in their first trimester of pregnancy
- Ages 18 and 40
You may not qualify if:
- lower limb joint or spinal surgery
- inflammatory joint or muscle problems such as rheumatoid or psoriatic arthritis
- diabetes
- collagen disorder such as Marfan Syndrome, Ehlers-Danlos Syndrome, Mixed Connective Tissue Disease, or Osteogenesis Imperfecta
- cannot walk without any assistance
- surgeries or have another medical condition that may affect their walking ability
- flat feet (absence of a longitudinal arch)
- inability to return for the follow-up visit 2 months after delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Iowa
Iowa City, Iowa, 52242, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neil Segal, M.D., M.S.
- Organization
- University of Iowa
Study Officials
- PRINCIPAL INVESTIGATOR
Neil A Segal, MD
University of Iowa
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 23, 2013
First Posted
June 4, 2013
Study Start
May 1, 2013
Primary Completion
September 1, 2013
Study Completion
June 1, 2014
Last Updated
August 2, 2016
Results First Posted
August 2, 2016
Record last verified: 2016-06