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Completed

NCT Number: NCT03842241

Effects of Fatigue and Foot Orthoses on Lower Extremity EMG and Biomechanics for Individuals With Flat Foot

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

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Key information

Conditions

Flexible Flatfoot Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Yang-Ming University

Taipei, 112, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-custom made foot orthoses

Device

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

Primary outcomes

  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 Delsys, 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 outcomes

  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 Delsys, 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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

Changes of Kinematics, Muscle Activity, Joint Contact Force of Foot Orthoses for Individual of Flat Foot After Functional Fatigue Protocol

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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