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

• Sponsor: National Yang Ming University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03842241
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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	Phase
Flexible Flatfoot	Device: Non-custom made foot orthoses

Study Design

• Study Type: Observational
• Actual Enrollment: 19 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: Dec 5, 2018
• Actual Primary Completion Date: Aug 31, 2019
• Actual Study Completion Date: Aug 31, 2019

Arms and Interventions

Arm	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

Primary Outcome Measures

1. 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]

   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 [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 [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 [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 [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 [1 minutes after fatigue protocol completed]

   Time of completed the course will be recorded.

4. 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]

   Hip, knee ,and ankle inter-joint contact force: Anybody modeling system is used to model the inter-joint contact force

5. 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]

   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

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	National Yang-Ming University	Taipei		Taiwan	112

Sponsors and Collaborators

• National Yang Ming University

Investigators

• Principal Investigator: Li-Wei Chou, PhD, National Yang Ming University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Yang Ming University
• ClinicalTrials.gov Identifier: NCT03842241
• Other Study ID Numbers: YM107091E
• First Posted: Feb 15, 2019
• Last Update Posted: Aug 17, 2022
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: Flatfoot

Study Results

No Results Posted as of Aug 17, 2022