Trial Outcomes & Findings for Study of Changes in the Feet With Pregnancy (NCT NCT01868074)
NCT ID: NCT01868074
Last Updated: 2016-08-02
Results Overview
Measurement of Arch Drop (Sitting arch height minus standing arch height) using Arch Height Index Measurement System
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
baseline, 8 weeks postpartum
Results posted on
2016-08-02
Participant Flow
Recruited from clinics affliated with the University of Iowa Hospitals and Clinics; from the clniical trials Website; and from local day care facilities, schools, and pregnancy excercise classes. Exclusion criteria included women participating in in vitro fertilization, previous lower limb or spinal surgery, \& chronic diseases.
Participant milestones
| Measure |
Customized Insole Group
Each participant in the intervention group had her insole customized to fit her typical daily footwear and was instructed to wear the insoles as often as possible. Participants in the intervention group had their feet molded by a certified orthotist, using a 3M, soft cast. The casting was done in a non-weight bearing, hind-foot neutral position so the insoles would preserve the long transverse arch and maintain a biomechanically efficient state to control motion at the foot and ankle. These castings were used to custom form insoles with the following characteristics: Footlights athletic or dress model (per participant shoe preference), with 3/16" semi-rigid shells, no arch fill, extrinsic rearfoot and standard intrinsic forefoot posting. A research team member not involved with outcome measurements met with the participants to give them their insoles and confirm they fit.
|
Usual Care Group
Participants in the control group were instructed to wear their usual footwear over the course of their pregnancy.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
29
|
32
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Customized Insole Group
Each participant in the intervention group had her insole customized to fit her typical daily footwear and was instructed to wear the insoles as often as possible. Participants in the intervention group had their feet molded by a certified orthotist, using a 3M, soft cast. The casting was done in a non-weight bearing, hind-foot neutral position so the insoles would preserve the long transverse arch and maintain a biomechanically efficient state to control motion at the foot and ankle. These castings were used to custom form insoles with the following characteristics: Footlights athletic or dress model (per participant shoe preference), with 3/16" semi-rigid shells, no arch fill, extrinsic rearfoot and standard intrinsic forefoot posting. A research team member not involved with outcome measurements met with the participants to give them their insoles and confirm they fit.
|
Usual Care Group
Participants in the control group were instructed to wear their usual footwear over the course of their pregnancy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
Study of Changes in the Feet With Pregnancy
Baseline characteristics by cohort
| Measure |
Customized Insole
n=36 Participants
These participants were casted for customized insoles.
|
Usual Care
n=36 Participants
Participants were instructed to wear their usual footwear over the course of their pregnancy.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.2 year
STANDARD_DEVIATION 4.6 • n=5 Participants
|
30.4 year
STANDARD_DEVIATION 4.4 • n=7 Participants
|
30.3 year
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Foot Length Sitting
|
240.4 mm
STANDARD_DEVIATION 13.5 • n=5 Participants
|
240.1 mm
STANDARD_DEVIATION 10.2 • n=7 Participants
|
240.25 mm
STANDARD_DEVIATION 11.85 • n=5 Participants
|
|
Foot Length Standing
|
242.8 mm
STANDARD_DEVIATION 10.2 • n=5 Participants
|
243.0 mm
STANDARD_DEVIATION 13.7 • n=7 Participants
|
242.9 mm
STANDARD_DEVIATION 11.95 • n=5 Participants
|
|
AHI Sitting
|
0.35 ratio
STANDARD_DEVIATION 0.02 • n=5 Participants
|
0.35 ratio
STANDARD_DEVIATION 0.02 • n=7 Participants
|
0.35 ratio
STANDARD_DEVIATION 0.02 • n=5 Participants
|
|
AHI Standing
|
0.33 ratio
STANDARD_DEVIATION 0.02 • n=5 Participants
|
0.33 ratio
STANDARD_DEVIATION 0.02 • n=7 Participants
|
0.33 ratio
STANDARD_DEVIATION 0.02 • n=5 Participants
|
|
Arch Drop
|
3.0 mm
STANDARD_DEVIATION 1.4 • n=5 Participants
|
2.8 mm
STANDARD_DEVIATION 1.1 • n=7 Participants
|
2.9 mm
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Arch Rigidity
|
0.94 ratio
STANDARD_DEVIATION 0.03 • n=5 Participants
|
0.94 ratio
STANDARD_DEVIATION .02 • n=7 Participants
|
0.94 ratio
STANDARD_DEVIATION 0.03 • n=5 Participants
|
|
Center of Pressure Excursion Index at self-selected speed
|
18.6 ratio
STANDARD_DEVIATION 6.2 • n=5 Participants
|
21.3 ratio
STANDARD_DEVIATION 6.3 • n=7 Participants
|
19.95 ratio
STANDARD_DEVIATION 6.25 • n=5 Participants
|
|
Center of Pressure Excursion Index (3mph)
|
18.1 ratio
STANDARD_DEVIATION 5.9 • n=5 Participants
|
20.8 ratio
STANDARD_DEVIATION 6.6 • n=7 Participants
|
19.9 ratio
STANDARD_DEVIATION 6.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 8 weeks postpartumMeasurement of Arch Drop (Sitting arch height minus standing arch height) using Arch Height Index Measurement System
Outcome measures
| Measure |
Customized Insole Group
n=29 Participants
This intervention group were casted for customized insoles.
|
Usual Care Group
n=32 Participants
Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
|
|---|---|---|
|
Change in Arch Drop
|
-.02 mm
Standard Error .15
|
.07 mm
Standard Error .14
|
SECONDARY outcome
Timeframe: baseline, 8 weeks postpartumThe 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.
Outcome measures
| Measure |
Customized Insole Group
n=29 Participants
This intervention group were casted for customized insoles.
|
Usual Care Group
n=32 Participants
Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
|
|---|---|---|
|
Change in Arch Rigidity
|
0 ratio
Standard Error 0
|
0 ratio
Standard Error 0
|
SECONDARY outcome
Timeframe: baseline, 8 weeks postpartumThe 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.
Outcome measures
| Measure |
Customized Insole Group
n=29 Participants
This intervention group were casted for customized insoles.
|
Usual Care Group
n=32 Participants
Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
|
|---|---|---|
|
Change in CPEI (3mph)
|
.21 ratio
Standard Error .56
|
-.02 ratio
Standard Error .53
|
Adverse Events
Customized Insole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place