Study of Changes in the Feet With Pregnancy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Foundation for Physical Medicine and Rehabilitation
Information provided by (Responsible Party):
Neil A Segal, University of Iowa
ClinicalTrials.gov Identifier:
NCT01868074
First received: May 23, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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 Intervention
Pregnancy
Device: Insole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Women's Health Through Assessing Foot Plasticity With Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Change in Arch Drop [ Time Frame: baseline, 8 weeks postpartum ] [ Designated as safety issue: No ]
    Measurement of Arch Drop (Sitting arch height minus standing arch height) using Arch Height Index Measurement System


Secondary Outcome Measures:
  • Change in Arch Height Index [ Time Frame: baseline, 8 weeks postpartum ] [ Designated as safety issue: No ]
    Change in the index of foot arch height when standing.


Estimated Enrollment: 70
Study Start Date: May 2013
Estimated Study Completion Date: August 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Intervention
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Neil A Segal, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01868074     History of Changes
Other Study ID Numbers: 201209787
Study First Received: May 23, 2013
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 15, 2014