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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06240156
• Other study ID #: 16-S-023-1
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: January 2024
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• flat Insole group
General Insole without any special features

Locations

Country	Name	City	State
Taiwan	Wan-Lin Pan	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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