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Changes of EMG and Biomechenics of Foot Orthoses for Individual of Flat Foot After Fatigue

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ClinicalTrials.gov Identifier: NCT03842241
Recruitment Status : Unknown
Verified February 2019 by National Yang Ming University.
Recruitment status was:  Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
National Yang Ming University

Study Description
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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

Condition or disease Intervention/treatment
Flexible Flatfoot Device: Non-custom made foot orthoses

Study Design
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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Changes of Kinematics, Muscle Activity, Joint Contact Force of Foot Orthoses for Individual of Flat Foot After Functional Fatigue Protocol
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Foot Health

Groups and Cohorts
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Group/Cohort Intervention/treatment
WIth foot orthoses
Device: Non-custom made foot orthoses
 Device: Non-custom made foot orthoses
Foot orthoses is an orthotic devices which are used to support arch and rear-foot and put it in a good alignment.
Without foot orthoses
Other: without foot orthoses


Outcome Measures
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Primary Outcome Measures :
  1. Lower extremities kinetic [ Time Frame: 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 ]

    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.


  2. Peak and average amplitude during stance phase [ Time Frame: 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 ]
    EMG data were collected using a Delyses, and Biopac EMG system during walking. Tibialis anterior/Peroneal longus/Abductor hallucis longus muscle activity were measured by electromyography (EMG).

  3. Lower extremities kinematic [ Time Frame: 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 limbs alignment, including hip, knee and ankle joints. Using motion capture system data to calculate the joint angles.


Secondary Outcome Measures :
  1. Lower extremities kinematic [ Time Frame: 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 ]

    Three dimensional kinematics were collected using a Vicon camera system during walking.

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


  2. Peak and average amplitude during stance phase [ Time Frame: 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 ]
    EMG data were collected using a Delyses, and Biopac EMG system during walking. Medial gastrocnemius/Rectus femoris/Bicep femoris muscle activity were measured by EMG.

  3. Time of completed fatigue protocols [ Time Frame: 1 minutes after fatigue protocol completed ]
    Time of completed the course will be recorded.

  4. Inter-joint contact force [ Time Frame: 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 ]
    Hip, knee ,and ankle inter-joint contact force: Anybody modeling system is used to model the inter-joint contact force

  5. Lower extremities kinetic [ Time Frame: 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 ]

    Three dimensional motion data were collected using a Vicon camera system during walking.

    Using motion capture system data to calculate the hip, knee flexion/extension, adduction/abduction moment and ankle dorsiflexion/plantarflexion, and adduction/abduction moment via inverse dynamics method.



Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Flexible flatfoot
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842241


Contacts
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Contact: Li-Wei Chou, PhD 2826-7092 lwchou@ym.edu.tw

Locations
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Taiwan
National Yang-Ming University Recruiting
Taipei, Taiwan, 112
Contact: Li-Wei Chou, PhD    +88628267092    lwchou@ym.edu.tw   
Contact: Chieh-Ning Huang    +8860916550174    jelly2318@gmail.com   
Sponsors and Collaborators
National Yang Ming University
Investigators
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Principal Investigator: Li-Wei Chou, PhD National Yang Ming University
More Information
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Responsible Party: National Yang Ming University
ClinicalTrials.gov Identifier: NCT03842241    
Other Study ID Numbers: YM107091E
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
 Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities