NCT03842241

Brief Summary

Determine the effects of non-custom made foot orthoses on the kinematics, muscle activity and joint contact force after fatigue and compare the rate of fatigue in flexible flat foot with and without foot orthoses

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

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

December 5, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

August 17, 2022

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

January 17, 2019

Last Update Submit

August 14, 2022

Conditions

Flexible Flatfoot

Outcome Measures

Primary Outcomes (3)

  • Lower extremities kinetic

    Three dimensional motion data were collected using a Vicon camera system during walking. Using motion capture system data to calculate the hip, knee internal/external rotation moment and ankle inversion/eversion moment via inverse dynamics method.

    10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed, after one week, 10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed

  • Peak and average amplitude during stance phase

    EMG data were collected using a Delsys, and Biopac EMG system during walking. Tibialis anterior/Peroneal longus/Abductor hallucis longus muscle activity were measured by electromyography (EMG).

    10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed, after one week, 10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed

  • Lower extremities kinematic

    Lower limbs alignment, including hip, knee and ankle joints. Using motion capture system data to calculate the joint angles.

    10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed, after one week, 10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed

Secondary Outcomes (5)

  • Lower extremities kinematic

    10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed, after one week, 10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed

  • Peak and average amplitude during stance phase

    10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed, after one week, 10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed

  • Time of completed fatigue protocols

    1 minutes after fatigue protocol completed

  • Inter-joint contact force

    10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed, after one week, 10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed

  • Lower extremities kinetic

    10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed, after one week, 10 minutes before fatigue protocol start, 5 minutes after fatigue protocol completed

Study Arms (2)

WIth foot orthoses

Device: Non-custom made foot orthoses

Device: Non-custom made foot orthoses

Without foot orthoses

Other: without foot orthoses

Interventions

Non-custom made foot orthosesDEVICE

Foot orthoses is an orthotic devices which are used to support arch and rear-foot and put it in a good alignment.

WIth foot orthoses

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Flexible flatfoot

You may qualify if:

  • Bilateral flexible flatfoot( navicular bone drop greater than 10 mm)

You may not qualify if:

  • History of foot and ankle surgery, inflammatory joint disease
  • History of lower extremity injury in six months
  • Known pathological or neurological disorders that could affect gait pattern

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

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

Study Officials

  • Li-Wei Chou, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

February 15, 2019

Study Start

December 5, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

August 17, 2022

Record last verified: 2019-02

Locations

TW(1)