Ankle Inversion SprainNCT05799885
The Effects of Combined Neuro-vestibular-ocular Exercises and Myofascial Release on Proprioception and Performance in Soccer Players With Chronic Ankle Instability
A study testing Neuro-vestibular-ocular group and Myofascial Release group in people with Ankle Inversion Sprain and Ankle Injuries, run by Yeditepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ankle Inversion Sprain, Ankle Injuries
- What is being tested?
- Neuro-vestibular-ocular group and Myofascial Release group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2023to 30 Sep 2023
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Ankle Inversion Sprain, Ankle Injuries
- Being tested
- Neuro-vestibular-ocular group, Myofascial Release group
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-vestibular-ocular groupOther
Neuro-vestibular-ocular exercise group (30 footballers)will do the exercises given in addition to their training
Myofascial Release groupOther
Manual myofascial release will be applied by the physiotherapist.(30 football players)
| Study group | Role | What they receive |
|---|---|---|
| 31 players with ankle instability | Experimental | 2 sessions per week for 8 weeks, total training time 30 min Receives: Other: Myofascial Release group |
| 30 players with ankle instability | Experimental | 2 sessions per week for 8 weeks, total training time 30-40 min Receives: Other: Neuro-vestibular-ocular group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: a day before the rehabilitation-at the time of discharge(8 weeks)
Secondary outcomes (5)
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.
Measured: a day before the rehabilitation-at the time of discharge(8 weeks)
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
Measured: a day before the rehabilitation-at the time of discharge(8 weeks)
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.
Measured: a day before the rehabilitation-at the time of discharge(8 weeks)
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
Measured: a day before the rehabilitation-at the time of discharge(8 weeks)
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.
Measured: a day before the rehabilitation-at the time of discharge(8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start2 Apr 2023 (estimated)
- Primary completion3 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Inversion SprainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Büşra Kocakılıç, master, Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799885
- Sponsor's protocol ID
- YEDITEPEU-BUSRAKOCAKILIC-0096
- Status last verified
- Jan 2023
- First submitted
- 13 Feb 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Neuro-vestibular-ocular Exercises and Myofascial Release on Proprioception and Performance in Soccer Players With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT05799885
- Acronym / sponsor ID
- YEDITEPEU-BUSRAKOCAKILIC-0096
- Conditions
- Ankle Inversion Sprain, Ankle Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 2 Apr 2023 (estimated)
- Primary completion
- 3 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 5 Apr 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 31 players with ankle instability | Experimental | Other: Myofascial Release group2 sessions per week for 8 weeks, total training time 30 min |
| 30 players with ankle instability | Experimental | Other: Neuro-vestibular-ocular group2 sessions per week for 8 weeks, total training time 30-40 min |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Neuro-vestibular-ocular groupNeuro-vestibular-ocular exercise group (30 footballers)will do the exercises given in addition to their training | Other | 30 players with ankle instability |
| Myofascial Release groupManual myofascial release will be applied by the physiotherapist.(30 football players) | Other | 31 players with ankle instability |
Primary outcome
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.
5 secondary outcomes
proprioception evaluation
Time frame: 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)
30 meters Sprint Test
Time frame: 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)
Kick Speed
Time frame: a day before the rehabilitation-at the time of discharge(8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Ankle Inversion Sprain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries
Ankle Sprains
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.
Büşra Kocakılıç, master principal investigator
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-vestibular-ocular group and Myofascial Release group in people with Ankle Inversion Sprain and Ankle Injuries, run by Yeditepe 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 4 inclusion and 3 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 5 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Tuğçe Çil, doctor (05544811092, elif.cil@yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAIT Scale (time frame: a day before the rehabilitation-at the time of discharge(8 weeks)). 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 5 Apr 2023.