- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05899855
Foot Positions Affect Knee and Ankle Proprioception, Balance, Vertical Jump, and Muscle Activity in Individuals With Flexible and Rigid Flatfoot and Chronic Ankle Instability
June 2, 2023 updated by: Ayman Mohamed, Beni-Suef University
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 Overview
Study Type
Observational
Enrollment (Estimated)
60
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
30 subjects with rigid flatfoot and chronic ankle instability
|
No intervention
|
|
Group II
30 subjects with flexible flatfoot and chronic ankle instability
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
knee proprioception
Time Frame: 2-3 months
|
knee proprioception
|
2-3 months
|
|
ankle proprioception
Time Frame: 2-3 months
|
ankle proprioception
|
2-3 months
|
|
Vertical jump measurements
Time Frame: 2-3 months
|
Vertical jump measurements
|
2-3 months
|
|
Electromyographical activity (EMG)
Time Frame: 2-3 months
|
Electromyographical activity (EMG)
|
2-3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2023
Primary Completion (Estimated)
October 30, 2023
Study Completion (Estimated)
October 30, 2023
Study Registration Dates
First Submitted
June 2, 2023
First Submitted That Met QC Criteria
June 2, 2023
First Posted (Actual)
June 12, 2023
Study Record Updates
Last Update Posted (Actual)
June 12, 2023
Last Update Submitted That Met QC Criteria
June 2, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cairo university (Other Grant/Funding Number: faculty of pedatric dentistry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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