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

NCT06240156 | Completed DMC

• 1 other identifier: 16-S-023-1
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Keywords

pregnancy, gait balance, foot pain, lower back pain

Outcome Measures

Primary Outcomes (5)

• plantar pressure

  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

  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

  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

  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

  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

Study Arms (2)

3D arch pad design Insole group

EXPERIMENTAL

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

flat Insole group

PLACEBO COMPARATOR

General Insole without any special features

Other: flat Insole group

Interventions

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.

3D arch pad design Insole group

flat Insole group OTHER

General Insole without any special features

flat Insole group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Wan-Lin Pan

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Meei-Ling Gau, PHD

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: March 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

TW (1)