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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05799885
Other study ID # YEDITEPEU-BUSRAKOCAKILIC-0096
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2, 2023
Est. completion date September 30, 2023

Study information

Verified date January 2023
Source Yeditepe University
Contact Elif Tugçe Çil, doctor
Phone 05544811092
Email elif.cil@yeditepe.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic ankle instability was first defined by Freeman as recurrent ankle sprains following an ankle sprain and the feeling of dislocation in the ankle lasting longer than six months. The recurrence of ankle sprains in athletes leads to the realization of ankle instability. Functional ankle instability gives the feeling that a re-sprain will occur at any time due to decreased static and dynamic support in the joint.Neuro-vestibular-ocular exercises is an approach that combines neuromuscular training and vestibular-ocular training techniques.At the same time, we are doing this study because of the mixed studies on the effect of fascial relaxation on the performance and proprioception of a specific group of football players.


Description:

A total of 60 football players with instability <27 according to the CAIT scale, whose proprioception and performance (jump, sprint, zig-zag test, kick speed) values were taken at the beginning, will be divided into two groups.Myofascial release will be applied to the lower extremity posterior line chain described by Myers by the physiotherapist to the first group.The other group (30 people) will be given neuro-vestibular-ocular exercises.Both groups will continue their training programme as ready.The training will be done in 2 sessions and 30 minutes per week.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 61
Est. completion date September 30, 2023
Est. primary completion date September 3, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria: - a history of 'giving way' and/or recurrent sprains and/or 'feeling of instability' in the injured ankle joint within the last 6 months. - decreased function due to ankle sprain history - "feeling of instability" will be defined as =27 points on the Cumberland ankle instability scale (CAIT) and the most affected side will be determined as the relevant limb for testing. CAIT score between right and left foot The dominant ankle will be selected. - Having had at least two previous lateral sprains in the same ankle. Exclusion Criteria: - history of musculoskeletal surgery and/or fractures in the lower extremities; - acute injury to the musculoskeletal structures of other lower extremity joints in the last three months that affects joint integrity and function and causes interruption of desired physical activity for at least one day; - having a history of balance and vestibular disorders.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Neuro-vestibular-ocular group
Neuro-vestibular-ocular exercise group (30 footballers)will do the exercises given in addition to their training
Myofascial Release group
Manual myofascial release will be applied by the physiotherapist.(30 football players)

Locations

Country Name City State
Turkey Büsra Istanbul Maltepe

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary CAIT Scale Participants will be included based on the CAIT questionnaire and who get 27 points or less from this questionnaire. In the test, cut off score of less or equal to 27 as indicate of chronic ankle instability. The precision of the instrument is increased as it is a multiple answer option instrument. The CAIT is able to measure the severity of instability by using a numeric value and also can be filled out for both the left and right ankle, making it possible to assess both ankles individually. a day before the rehabilitation-at the time of discharge(8 weeks)
Secondary proprioception evaluation The goniometer is used as a tool to measure proprioceptive perception of the ankle joint.
Subjects are placed in the starting position with their eyes closed. The ankle subtalar joint is in neutral position (STJN) and the goniometer is set to zero. 20 degrees of inversion and 10 degrees of eversion are passively performed on the ankle and it is placed in neutral position.(13) The measurements are repeated 3 times and deviations from the target angle are measured with a goniometer.
a day before the rehabilitation-at the time of discharge(8 weeks)
Secondary Landing Error Scoring System (LESS) Jumping performance will be measured by Landing Error Scoring System (LESS). Materials required for this;12 inch platform Target line (At a distance of half the subjects height)2 cameras at 1 meter height (At 10 feet in front of the landing area and at 10 feet to the right of the landing area)LESS scale.The athlete is instructed to jump forward from the box with both feet.Both feet should make contact beyond the target line.After contact, jump right back up to maximal height and land again on both feet.This is repeated for three trials.The video of the jumps is taken from both the cameras in front and at the side.The feet, ankle, knees, hip, trunk, shoulder, neck and head posture is assessed through the video.It is a 19-point continuous scale. According to the performance sheet, the questions 1-15 are Yes/No questions that are rated as 0 or 1. The questions 16 and 17 are rated as 0,1 and 2 depending on the joint displacement a day before the rehabilitation-at the time of discharge(8 weeks)
Secondary 30 meters Sprint Test Sprint performance will be assessed by a 30-meter sprint test. A maximal 30 m sprint will be performed 3 times on the field. There is a 3-minute recovery period between the 30-m sprints. The shortest time taken to cover the 30 m distance in the sprint test will be taken into account. a day before the rehabilitation-at the time of discharge(8 weeks)
Secondary Zigzag agility test(with and without the ball) There was a recovery time of 2 minutes between trials. The shortest time will be recorded as the performance of the zigzag agility tests with and without the ball. In the test, 4 cones are placed at the corners and 1 cone is placed in the center of the track. The long side of the track is 4,05 m (16 feet), the short side is 3 m (10 feet) (1feet=0,3 m)In the zigzag agility test with the ball, there is no specific rule such as the number of ball contacts. Time was measured using a stopwatch a day before the rehabilitation-at the time of discharge(8 weeks)
Secondary Kick Speed The ball will be placed 11 meters away from the goal line. Cones will be placed 1 and 2 meters away from the starting position of the ball. The player will stand next to the cone at the 2nd meter and accelerate. Participants will be asked to kick the ball as fast as possible using the inside of the unstable foot. The measurement will be done with the apple app called "speed gun". The rest time between attempts will be 20 seconds. They will be told not to reduce the speed to improve the accuracy of the shot, the best time will be included in the trial results. a day before the rehabilitation-at the time of discharge(8 weeks)
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