FlatfootNCT05899855
Foot Positions Affect Knee and Ankle Proprioception, Balance, Vertical Jump, and Muscle Activity in Individuals With Flexible and Rigid Flatfoot and Chronic Ankle Instability
An observational study of Flatfoot, run by Beni-Suef University.
Trial summary
To investigate the effect of various foot positions affect knee and ankle proprioception, balance, vertical jump, and muscle activity in individuals with flexible and rigid flatfoot and chronic ankle instability Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Flatfoot
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 30 Oct 2023
- 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 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Study population: Seventy-six participants met the inclusion and exclusion of this study. These participants were screened for the type of FF. We chose 30 for each group (60 total) to accomplish the balance between groups. Group 1: 30 subjects with rigid FF and chronic ankle instability, and Group 2: 30 subjects with flexible FF and chronic ankle instability. All participants were blinded to study procedures.
Who may be able to join
- The inclusion criteria were the presence of FF and chronic ankle instability in the dominant foot. Flexible and rigid flat feet were initially diagnosed by an orthopedist using a weight-bearing position with a standardized radiograph technique. The digital X-ray detector (film) and the X-ray tube (source) are 35-40 inches apart in lateral views of the foot. Then, Jack's test was performed to differentiate between the flexible and rigid FF. Jack's test is a valid test in assessing FF 10. Finally, people with flexible a second degree FF (Meary's angle between 15° to 30°) 3 were included in this study. The degree of flatfoot was determined by measuring the talus-first metatarsal angle on a lateral weight-bearing radiograph. This angle lies between a line drawn from the centers of the longitudinal axes of the talus and the first metatarsal. An angle that is greater than 4° convex downward is considered pes planus with an angle of 15° - 30° considered moderate, and greater than 30° severe 8. Chronic ankle instability was defined as the subject had a minimum of 2 acute ankle sprains, in the last 6 months, associated with pain, swelling, and a record of various ankle giving way. The determination of the dominant foot followed Vauhnik. \& ark, modified version which stated that the dominant foot should be used minimally in 2 of the 3 subsequent activities: (1) Using the leg to step over a spider toy, (2) Drawing a diamond figure on the ground and (3) Kicking a ball.
Who cannot join
- The exclusion criteria were the existence of limited hallux dorsiflexion because Jack's test is valid only if hallux dorsiflexion is available during relaxed standing. Also, the participants were excluded if they had previous hip, pelvis, knee, or foot surgeries within the last year; obesity or pregnancy; leg-length discrepancies; has any vestibular disorder neurological disorder, brain concussion within the last 3 months that may cause balance impairment; or administering any drugs that could disturb alertness or balance.
About this study
To investigate the effect of various foot positions affect knee and ankle proprioception, balance, vertical jump, and muscle activity in individuals with flexible and rigid flatfoot and chronic ankle instability
- Conditions
- Flatfoot
- Being tested
- No intervention
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 30 subjects with rigid flatfoot and chronic ankle instability Receives: Other: No intervention | |
| Group II | 30 subjects with flexible flatfoot and chronic ankle instability Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee proprioception
knee proprioception
Measured: 2-3 months
ankle proprioception
ankle proprioception
Measured: 2-3 months
Vertical jump measurements
Vertical jump measurements
Measured: 2-3 months
Electromyographical activity (EMG)
Electromyographical activity (EMG)
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlatfootStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Mohamed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899855
- Sponsor's protocol ID
- Cairo university
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Positions Affect Knee and Ankle Proprioception, Balance, Vertical Jump, and Muscle Activity in Individuals With Flexible and Rigid Flatfoot and Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT05899855
- Acronym / sponsor ID
- Cairo university
- Conditions
- Flatfoot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 12 Jun 2023 (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.
To investigate the effect of various foot positions affect knee and ankle proprioception, balance, vertical jump, and muscle activity in individuals with flexible and rigid flatfoot and chronic ankle instability
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No intervention30 subjects with rigid flatfoot and chronic ankle instability |
| Group II | – | Other: No intervention30 subjects with flexible flatfoot and chronic ankle instability |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Seventy-six participants met the inclusion and exclusion of this study. These participants were screened for the type of FF. We chose 30 for each group (60 total) to accomplish the balance between groups. Group 1: 30 subjects with rigid FF and chronic ankle instability, and Group 2: 30 subjects with flexible FF and chronic ankle instability. All participants were blinded to study procedures.
Key inclusion criteria (1 listed)
- The inclusion criteria were the presence of FF and chronic ankle instability in the dominant foot. Flexible and rigid flat feet were initially diagnosed by an orthopedist using a weight-bearing position with a standardized radiograph technique. The digital X-ray detector (film) and the X-ray tube (source) are 35-40 inches apart in lateral views of the foot. Then, Jack's test was performed to differentiate between the flexible and rigid FF. Jack's test is a valid test in assessing FF 10. Finally, people with flexible a second degree FF (Meary's angle between 15° to 30°) 3 were included in this study. The degree of flatfoot was determined by measuring the talus-first metatarsal angle on a lateral weight-bearing radiograph. This angle lies between a line drawn from the centers of the longitudinal axes of the talus and the first metatarsal. An angle that is greater than 4° convex downward is considered pes planus with an angle of 15° - 30° considered moderate, and greater than 30° severe 8. Chronic ankle instability was defined as the subject had a minimum of 2 acute ankle sprains, in the last 6 months, associated with pain, swelling, and a record of various ankle giving way. The determination of the dominant foot followed Vauhnik. \& ark, modified version which stated that the dominant foot should be used minimally in 2 of the 3 subsequent activities: (1) Using the leg to step over a spider toy, (2) Drawing a diamond figure on the ground and (3) Kicking a ball.
Key exclusion criteria (1 listed)
- The exclusion criteria were the existence of limited hallux dorsiflexion because Jack's test is valid only if hallux dorsiflexion is available during relaxed standing. Also, the participants were excluded if they had previous hip, pelvis, knee, or foot surgeries within the last year; obesity or pregnancy; leg-length discrepancies; has any vestibular disorder neurological disorder, brain concussion within the last 3 months that may cause balance impairment; or administering any drugs that could disturb alertness or balance.
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 |
|---|---|---|
| No interventionNo intervention | Other | Group 1, Group II |
Primary outcome
knee proprioception
Time frame: 2-3 months
knee proprioception
ankle proprioception
Time frame: 2-3 months
ankle proprioception
Vertical jump measurements
Time frame: 2-3 months
Vertical jump measurements
Electromyographical activity (EMG)
Time frame: 2-3 months
Electromyographical activity (EMG)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Flatfoot, run by Beni-Suef University.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
knee proprioception (time frame: 2-3 months). The study lists 4 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 12 Jun 2023.