Foot, FlatNCT03607253
Muscle Fatigue and Foot Biomechanics
A study testing repetitive heel rise activity in people with Foot, Flat, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Medial longitudinal arch (MLA) is a curve of the foot located at the medial side of the body and protection of the height of the MLA is an important factor for limb health. This study was planned with the aim of investigating the response of the MLA height to the repetitive muscle activity and determine the… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot, Flat
- What is being tested?
- repetitive heel rise activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2018to 30 Oct 2018
- Phase
- Interventional
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy young females and males who want to participate to the study
Who cannot join
- have orthopedic, physiologic, psychiatric, neurologic or systemic disorders
- have present medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Gender-related Response of Muscle Fatigue of the Medial Longitudinal Arch Height in Healthy Young
Medial longitudinal arch (MLA) is a curve of the foot located at the medial side of the body and protection of the height of the MLA is an important factor for limb health.
This study was planned with the aim of investigating the response of the MLA height to the repetitive muscle activity and determine the gender-related differences.
- Conditions
- Foot, Flat
- Being tested
- repetitive heel rise activity
- Keywords
- medial longitudinal arch, foot
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive heel rise activityOther
Participants will perform a maximal number of single-legged heel rises on a 10 degrees incline board. Participants will be permitted to apply for fingertip support at shoulder height on a wall in front of them. The test will be terminated when participants could no longer lift their heels from the incline board. The number of correct heel rises will be counted for each leg and will be used as Heel Rise Test score.
| Study group | Role | What they receive |
|---|---|---|
| Men | Other | Healthy young men aged between 18-25 years Receives: Other: repetitive heel rise activity |
| Women | Other | Healthy young women aged between 18-25 years Receives: Other: repetitive heel rise activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navicular Drop
Vertical distance of navicular tuberosity (highest point of the MLA) to the ground is measured for two times. First; with the foot placed in subtalar joint neutral position in full weight-bearing and second; in relaxed standing position. The difference between the two values are recorded as Navicular Drop (mm).
Measured: at first minute, change from baseline arch height at 2nd minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start30 Sep 2018
- Primary completion15 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot, FlatStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halit SELÇUK, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607253
- Sponsor's protocol ID
- TUTF-BAEK 2018/159
- Status last verified
- Nov 2018
- First submitted
- 19 Jul 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Gender-related Response of Muscle Fatigue of the Medial Longitudinal Arch Height in Healthy Young
- ClinicalTrials.gov ID
- NCT03607253
- Acronym / sponsor ID
- TUTF-BAEK 2018/159
- Conditions
- Foot, Flat
- Keywords
- medial longitudinal arch, foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 31 Jul 2018 (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.
Medial longitudinal arch (MLA) is a curve of the foot located at the medial side of the body and protection of the height of the MLA is an important factor for limb health.
This study was planned with the aim of investigating the response of the MLA height to the repetitive muscle activity and determine the gender-related differences.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men | Other | Other: repetitive heel rise activityHealthy young men aged between 18-25 years |
| Women | Other | Other: repetitive heel rise activityHealthy young women aged between 18-25 years |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy young females and males who want to participate to the study
Key exclusion criteria (2 listed)
- have orthopedic, physiologic, psychiatric, neurologic or systemic disorders
- have present medication
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 |
|---|---|---|
| repetitive heel rise activityParticipants will perform a maximal number of single-legged heel rises on a 10 degrees incline board. Participants will be permitted to apply for fingertip support at shoulder height on a wall in front of them. The test will be terminated when participants could no longer lift their heels from the incline board. The number of correct heel rises will be counted for each leg and will be used as Heel Rise Test score. | Other | Men, Women |
Primary outcome
Navicular Drop
Time frame: at first minute, change from baseline arch height at 2nd minutes
Vertical distance of navicular tuberosity (highest point of the MLA) to the ground is measured for two times. First; with the foot placed in subtalar joint neutral position in full weight-bearing and second; in relaxed standing position. The difference between the two values are recorded as Navicular Drop (mm).
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 14 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive heel rise activity in people with Foot, Flat, run by Trakya University at 1 site in Turkey (Türkiye).
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 2 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 14 Nov 2018. 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 Turkey (Türkiye). 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?
Navicular Drop (time frame: at first minute, change from baseline arch height at 2nd minutes). 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 14 Nov 2018.