A Study on Plantar Pressure Distribution, Gait Balance and Lower Back Pain in Pregnant Women

Effect of Insole Intervention on Plantar Pressure Distribution, Gait Balance and Lower Back Pain in Flatfoot Women During the Third Trimester

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06240156

Enrollment

Registered

2024-02-02

Start date

2017-03-01

Completion date

2019-07-31

Last updated

2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

pregnancy, gait balance, foot pain, lower back pain

Brief summary

The purpose of this study was to understand women with low arched feet, flat feet, or BMI\> 29 in the third trimester.

Detailed description

The purpose of this study was to understand women with low arched feet, flat feet, or BMI\> 29 in the third trimester. Compare the intervention measures of different foot pads immediately, two weeks, four weeks, and six weeks after the intervention Immediate and long-term benefits in relief of plantar pressure, dynamic and static balance, and lower back pain.

Interventions

OTHER3D arch pad design Insole group

3D three-dimensional design that is already available on the market (patent number I315187). Its arch support principle is designed using 3DBS (Three-Dimensional Biomechanics System - 3DBS), which can conform to the user's feet.

OTHERflat Insole group

General Insole without any special features

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* able to understand and write Chinese * health and third trimester women * low arched feet or flat feet or BMI\> 29

Exclusion criteria

* Women with a medical record of back, foot, ankle, knee, musculoskeletal, or neuromuscular trauma or disease

Design outcomes

Primary

Measure	Time frame	Description
plantar pressure	footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention	The pedar® system, an accurate and reliable pressure distribution measuring system designed to monitor local loads between the foot and the shoe.
static balance	footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention	The Timed Up and Go (TUG) test is utilized to assess mobility. It is a simple evaluation that measures the speed at which you can stand up, walk 10 feet, turn around, walk back, and sit down.
foot pain	footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention	The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
lower back pain	footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention	The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
daily life disturbance scales	footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention	The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026