- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05799885
The Effects of Combined Neuro-vestibular-ocular Exercises and Myofascial Release on Proprioception and Performance in Soccer Players With Chronic Ankle Instability
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elif Tuğçe Çil, doctor
- Phone Number: 05544811092
- Email: elif.cil@yeditepe.edu.tr
Study Contact Backup
- Name: Büşra Kocakılıç, master
- Phone Number: 05388548632
- Email: busrakocakilic@gmail.com
Study Locations
-
-
Maltepe
-
Istanbul, Maltepe, Turkey, 34776
- Büşra
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 31 players with ankle instability
2 sessions per week for 8 weeks, total training time 30 min
|
Manual myofascial release will be applied by the physiotherapist.(30
football players)
|
|
Experimental: 30 players with ankle instability
2 sessions per week for 8 weeks, total training time 30-40 min
|
Neuro-vestibular-ocular exercise group (30 footballers)will do the exercises given in addition to their training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CAIT Scale
Time Frame: a day before the rehabilitation-at the time of discharge(8 weeks)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
proprioception evaluation
Time Frame: a day before the rehabilitation-at the time of discharge(8 weeks)
|
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)
|
|
Landing Error Scoring System (LESS)
Time Frame: a day before the rehabilitation-at the time of discharge(8 weeks)
|
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)
|
|
30 meters Sprint Test
Time Frame: a day before the rehabilitation-at the time of discharge(8 weeks)
|
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)
|
|
Zigzag agility test(with and without the ball)
Time Frame: a day before the rehabilitation-at the time of discharge(8 weeks)
|
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)
|
|
Kick Speed
Time Frame: a day before the rehabilitation-at the time of discharge(8 weeks)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Büşra Kocakılıç, master, Yeditepe University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YEDITEPEU-BUSRAKOCAKILIC-0096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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