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

January 25, 2024 updated by: Wan-Lin Pan, National Taipei University of Nursing and Health Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Wan-Lin Pan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Placebo Comparator: flat Insole group
General Insole without any special features
Other: flat Insole group
General Insole without any special features

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plantar pressure
Time Frame: 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.
footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
static balance
Time Frame: 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.
footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
foot pain
Time Frame: 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.
footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
lower back pain
Time Frame: 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.
footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
daily life disturbance scales
Time Frame: 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.
footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Investigators

  • Principal Investigator: Meei-Ling Gau, PHD, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Estimated)

February 2, 2024

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-S-023-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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