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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: flat Insole group; Other: 3D arch pad design Insole group

• Registration Number: NCT06240156
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

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.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
flat Insole group	flat Insole group	General Insole without any special features
3D arch pad design Insole group	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Wan-Lin Pan; 🇨🇳 Taipei, Taiwan