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

NCT ID: NCT06240156

Last Updated: 2024-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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3D arch pad design Insole group

This study utilizes a custom-made arch support pad with a 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. In this type, the bottom layer provides an overall shock-absorbing function.

Group Type EXPERIMENTAL

3D arch pad design Insole group

Intervention Type OTHER

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.

flat Insole group

General Insole without any special features

Group Type PLACEBO_COMPARATOR

flat Insole group

Intervention Type OTHER

General Insole without any special features

Interventions

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3D 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.

Intervention Type OTHER

flat Insole group

General Insole without any special features

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Wan-Lin Pan

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meei-Ling Gau, PHD

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

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Wan-Lin Pan

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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16-S-023-1

Identifier Type: -

Identifier Source: org_study_id

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