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

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

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

Study Overview

• Status: Completed
• Conditions: Flexible Flatfoot
• Intervention / Treatment: Device: Non-custom made foot orthoses

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • National Yang-Ming University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Flexible flatfoot

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower extremities kinematic	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.	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. Medial gastrocnemius/Rectus femoris/Bicep femoris muscle activity were measured by 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
Time of completed fatigue protocols	Time of completed the course will be recorded.	1 minutes after fatigue protocol completed
Inter-joint contact force	Hip, knee ,and ankle inter-joint contact force: Anybody modeling system is used to model the 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	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.	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

Collaborators and Investigators

• Sponsor: National Yang Ming University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2018
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 14, 2022
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: YM107091E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No