ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Changes in the Feet With Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01868074
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Collaborator:
Foundation for Physical Medicine and Rehabilitation
Information provided by (Responsible Party):
Neil A Segal, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Pregnancy Device: Insole Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Women's Health Through Assessing Foot Plasticity With Pregnancy
Study Start Date : May 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Usual
Participants who are not randomized to the fitted insole intervention
Experimental: Insole
Participants randomized to use of a custom-molded insole during pregnancy
Device: Insole
Custom-molded arch-supporting insole



Primary Outcome Measures :
  1. Change in Arch Drop [ Time Frame: baseline, 8 weeks postpartum ]
    Measurement of Arch Drop (Sitting arch height minus standing arch height) using Arch Height Index Measurement System


Secondary Outcome Measures :
  1. Change in Arch Rigidity [ Time Frame: baseline, 8 weeks postpartum ]
    The arch rigidity index, a measure of the ability of the foot to maintain the arch when weight-bearing, was determined by dividing the standing AHI by the seated AHI. A value of 1.0 would indicate a perfectly rigid arch, while smaller values would indicate a more flexible arch.

  2. Change in CPEI (3mph) [ Time Frame: baseline, 8 weeks postpartum ]
    The Center of Pressure Excursion Index (CPEI) is a measurement of the lateral displacement of the center of pressure curve from a reference line drawn from the initial to the final centers of pressure during stance phase of gait, and standardized to the width of the anterior third of the foot during pedobarography.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women in their first trimester of pregnancy
  • Ages 18 and 40

Exclusion Criteria:

  • 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

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): NCT01868074


Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Foundation for Physical Medicine and Rehabilitation
Investigators
Principal Investigator: Neil A Segal, MD University of Iowa

Responsible Party: Neil A Segal, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01868074     History of Changes
Other Study ID Numbers: 201209787
First Posted: June 4, 2013    Key Record Dates
Results First Posted: August 2, 2016
Last Update Posted: August 2, 2016
Last Verified: June 2016

Keywords provided by Neil A Segal, University of Iowa:
pregnancy, arch height, collapsed arch