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Completed

NCT Number: NCT06240156

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

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

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wan-Lin Pan

Taipei, 114, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D arch pad design Insole group

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

Other

General Insole without any special features

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 2, 2024
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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