Flexible FlatfootNCT03842241
Effects of Fatigue and Foot Orthoses on Lower Extremity EMG and Biomechanics for Individuals With Flat Foot
An observational study of Flexible Flatfoot, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Flexible Flatfoot
- What is being tested?
- Non-custom made foot orthoses
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Dec 2018to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Flexible flatfoot
Who may be able to join
- Bilateral flexible flatfoot( navicular bone drop greater than 10 mm)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Flexible Flatfoot
- Being tested
- Non-custom made foot orthoses
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-custom made foot orthosesDevice
Foot orthoses is an orthotic devices which are used to support arch and rear-foot and put it in a good alignment.
| Study group | Role | What they receive |
|---|---|---|
| WIth foot orthoses | Device: Non-custom made foot orthoses Receives: Device: Non-custom made foot orthoses | |
| Without foot orthoses | Other: without foot orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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 outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start5 Dec 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible FlatfootStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Wei Chou, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842241
- Sponsor's protocol ID
- YM107091E
- Status last verified
- Feb 2019
- First submitted
- 17 Jan 2019
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Kinematics, Muscle Activity, Joint Contact Force of Foot Orthoses for Individual of Flat Foot After Functional Fatigue Protocol
- ClinicalTrials.gov ID
- NCT03842241
- Acronym / sponsor ID
- YM107091E
- Conditions
- Flexible Flatfoot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WIth foot orthoses | – | Device: Non-custom made foot orthosesDevice: Non-custom made foot orthoses |
| Without foot orthoses | – | –Other: without foot orthoses |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Flexible flatfoot
Key inclusion criteria (1 listed)
- Bilateral flexible flatfoot( navicular bone drop greater than 10 mm)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-custom made foot orthosesFoot orthoses is an orthotic devices which are used to support arch and rear-foot and put it in a good alignment. | Device | WIth foot orthoses |
Primary outcome
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.
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).
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.
5 secondary outcomes
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
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
Time of completed fatigue protocols
Time frame: 1 minutes after fatigue protocol completed
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
Related trials for Flexible Flatfoot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Active, not recruitingObservational study
Clinical and Functional Outcomes After Subtalar Arthroereisis in Pediatric Flexible Flatfoot
Pediatric Flexible Flatfoot
Not yet recruiting
Effect of Foot Orthoses on Kneecap Position in Adults With Flexible Flatfoot
Patellofemoral Joint, Flatfoot
Recruiting
Effects of Hip-Based Versus Knee-Based Exercises on Medial Longitudinal Arch, Dynamic Balance, and Muscle Strength in Flexible Flatfoot
Flexible Flatfoot, Flexible Flatfoot or Pes Planus
Not yet recruiting
Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
Flexible Flatfoot or Pes Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Wei Chou, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flexible Flatfoot, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.