N/A
Completed N=72
Study of Changes in the Feet With Pregnancy
Source: ClinicalTrials.gov NCT01868074 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Change in Arch Drop — -.02; .07 mm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Arch Drop |
-.02; .07 | — |
| SECONDARY Change in Arch Rigidity |
0; 0 | — |
| SECONDARY Change in CPEI (3mph) |
.21; -.02 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01868074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.