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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06240156
Other study ID # 16-S-023-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 pedarĀ® 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
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