NCT04381039

Brief Summary

The aim of present study is to compare the effects of 3D printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

May 5, 2020

Last Update Submit

October 18, 2021

Conditions

Flexible Flatfoot

Outcome Measures

Primary Outcomes (1)

  • F-scan system

    measure peak plantar pressure, contact area, peak force and center of pressure excursion index during walking and center of pressure velocity and center of pressure 95% ellipse area during one leg stance by F-scan system

    after wearing insole (immediate effect)

Secondary Outcomes (2)

  • Visual analogue scale

    after wearing insole (immediate effect)

  • Foot function index

    after wearing each insole for a week (at least 6 hours per day)

Study Arms (1)

customized insole group

EXPERIMENTAL
Device: Insole

Interventions

InsoleDEVICE

3D printing insole (Nylon), 3D printing insole (TPU), CNC machine insole (EVA), shoe only

customized insole group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 20 and 65 years old
  • Appearance of decreased medial arch
  • Foot posture index score between 6 to 12

You may not qualify if:

  • History of injuries of the lower extremity within the past 6 months
  • Experience of use of orthopedic insole within the past 6 months
  • Acute disorders in the lower extremities and spine
  • History of surgery on the lower extremities and lumbar spine within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical therapy center, national Taiwan university hosipital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Flatfoot

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 8, 2020

Study Start

May 1, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

October 20, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)