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

Flexible Flatfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842241
• Other study ID #: YM107091E
• Status: Completed
• Start date: December 5, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: February 2019
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Flatfoot
• Flexible Flatfoot

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Time of completed fatigue protocols	Time of completed the course will be recorded.	1 minutes after fatigue protocol completed
Secondary	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
Secondary	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