Ankle InjuriesNCT03872973
The Effect of Visual Input in Athletes With Chronic Ankle Instability
A study testing Neuromuscular Training and Strobe Glasses in people with Ankle Injuries, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of neuromuscular training on balance by using stroboscopic glasses in athletes with chronic ankle instability. Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Neuromuscular Training and Strobe Glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2019to 12 Oct 2019
- 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 18 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To have at least 5 years active athletes in any sports branch.
- The first sprain history of individuals should be inflammatory symptoms (pain, swelling) at least 1 year before the study,
- Individuals should have unilateral ankle sprain,
- The newest sprain must have occurred 3 months before or after the date of commencement,
- Individuals must have at least 2 times a feeling of instability within 6 months,
- Individuals should not have any ankle fractures in the past
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- Individuals should have undergone no surgical procedure to affect the sensorimotor function in the lower extremity.
- IDFAI (Identification of Functional Ankle Instability Questionare) score is above 11,
- FAAM (Foot and Ankle Ability Measure) score less than 90%,
- FAAM-S (Foot and Ankle Ability Measure Sport Scale) score should be less than 80%.
Who cannot join
- Individuals who are not active athletes for at least 5 years in any sports branch.
- First sprain history of individuals with inflammatory symptoms (pain, swelling) at least 1 year before the study.
- The absence of unilateral ankle sprain by individuals.
- The most recent buckling is that it did not take place 3 months before or after the date of commencement.
- Individuals should not have a feeling of instability for at least 2 times within 6 months.
- People experience ankle fractures in the past.
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- Individuals have undergone surgery to affect the sensorimotor function in the lower extremity.
- IDFAI (Identification of Functional Ankle Questionability) score not more than 11.
- FAAM (Foot and Ankle Ability Measure) score not less than 90%. FAAM-S (Foot and Ankle Ability Measure Sport Scale) score not less than 80%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Visual Input on Balance, Neural Feedback, Function and Running Mechanics in Athletes With Chronic Ankle Instability
The aim of this study is to investigate the effect of neuromuscular training on balance by using stroboscopic glasses in athletes with chronic ankle instability.
Read the detailed description
Lateral ankle sprain (LAB) is one of the most common musculoskeletal injuries of 15% of all injuries reported in all sports.Chronic ankle instability (CAI) is characterized by life-long persistent symptoms in 40% of people with recurrent LAB sprain.
It has been reported that there is a change in sensorimotor function in the activity of individuals with CAI, and they are more dependent on visual information in balance parameters on one leg.While the somatosensory input was clinically feasible; The obstruction of the visual input has been limited in two ways, the eyes being fully open or fully enclosed.However, this changing dynamic has provided a means for the prevention of visual input during more sporty maneuvers, to directly reach compensatory neuroplastic sequelae after injury and to function in a functional way to train the neuromuscular system.This technological innovation makes this possible by reducing the visual input without completely eliminating it.This innovation, called stroboscopic goggles technology, provides a mechanism to disrupt to any degree between eyes closed and open in the visual system.
Stroboscopic vision, characterized by intermittent vision obstruction, can be a clinical tool that allows clinicians to study sensory feedback in a progressive manner without fully seeing visual information. So use stroboscopic goggles to prevent visual information, you can improve the functionality by emphasizing the somatosensor information.In particular, visual manipulations can significantly influence the healthy adult electrocortical dynamics and balance control by triggering the contradiction between visual adult, vestibular and proprioceptive inputs.
The aim of this study, which was planned for this purpose, will be to evaluate the effects of neuromuscular exercises performed on stroboscopic environment on equilibrium, neural feedback and running mechanics.
- Conditions
- Ankle Injuries
- Being tested
- Neuromuscular Training, Strobe Glasses
- Keywords
- balance, chronic ankle instability, function, running
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular TrainingOther
The experimental group will perform neuromuscular exercise for 6 weeks.
The other experimental group will perform neuromuscular exercises with strobe glasses.
Strobe GlassesOther
Stroboscopic glasses, which is characterized by intermittent vision obstruction, is a clinical tool that allows clinicians to examine sensory feedback in a progressive manner without fully seeing visual information.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Neuromuscular training will be performed in this group for 6 weeks. Receives: Other: Neuromuscular Training |
| Strobe Group | Experimental | This group will perform neuromuscular training for 6 weeks with a strobe glasses. Receives: Other: Neuromuscular Training; Other: Strobe Glasses |
| Control Group | No intervention | This group will not perform any neuromuscular training program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAAM (Foot and Ankle Ability Measure),
Pre-test evaluation will be done. After the end of neuromuscular training for 6 weeks, the final test will be evaluated. This value will be saved as %.
Measured: 8 weeks
Ankle ROM
The two bars of Optojump are placed on the treadmill with a speed of 3.5m / sec and the foot strokes, imbalance and heel strokes will be recorded and the normal joint movements of the ankle with the Myo-motion device will be recorded.
Measured: 2 weeks
Balance
Static and dynamic balances of athletes before and after neuromuscular training will be evaluated. Center of pressure area (COP) foot pressure point shall be evaluated in mm. And İt is defined as a measure indicative of the time and/or distance a subject spent away from a central point.
Measured: 2 weeks
EEG (Electroencephalography)
The theta and beta waveform of EEG values of people will be measured during the static and dynamic balance evaluation.
Measured: 2 weeks
FAAM-S (Foot and Ankle Ability Measure Sport Scale)
Pre-test evaluation will be done. After the end of neuromuscular training for 6 weeks, the final test will be evaluated. The Sports subscale is scored the same as FAAM (Foot and Ankle Ability Measure) 4 being 'no difficulty at all' to 0 being 'unable to do'. The score on each item are added together to get the item score total. The number of items with a response is multiplied by 4 to get the highest potential score. If the subject answers all 8 items the highest potential score is 32, if one item is not answered the highest potential score is 28, if two are not answered the highest potential score is 24, etc. The item score total is divided by the highest potential score. This value is multiplied by 100 to get a percentage. A higher score represents a higher level of physical function.
Measured: 8 weeks
BMI (Body Mass Index)
Body mass index will be calculated before neuromuscular training. It will be evaluated in kg/m2.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start5 Mar 2019
- Primary completion10 Jun 2019
- Study completion12 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Uzlaşır, Hacettepe University
- Investigators
- Serkan UZLAŞIR, Study director, Nevşehir Hacı Bektaş Veli University Sports Science Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872973
- Sponsor's protocol ID
- 2018.14.163
- Status last verified
- Dec 2019
- First submitted
- 6 Mar 2019
- Last updated
- 10 Dec 2019
- Results posted
- 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 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visual Input on Balance, Neural Feedback, Function and Running Mechanics in Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03872973
- Acronym / sponsor ID
- 2018.14.163
- Conditions
- Ankle Injuries
- Keywords
- balance, chronic ankle instability, function, running
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 12 Oct 2019 (actual)
- First posted
- 13 Mar 2019 (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.
The aim of this study is to investigate the effect of neuromuscular training on balance by using stroboscopic glasses in athletes with chronic ankle instability.
Detailed description
Lateral ankle sprain (LAB) is one of the most common musculoskeletal injuries of 15% of all injuries reported in all sports.Chronic ankle instability (CAI) is characterized by life-long persistent symptoms in 40% of people with recurrent LAB sprain.
It has been reported that there is a change in sensorimotor function in the activity of individuals with CAI, and they are more dependent on visual information in balance parameters on one leg.While the somatosensory input was clinically feasible; The obstruction of the visual input has been limited in two ways, the eyes being fully open or fully enclosed.However, this changing dynamic has provided a means for the prevention of visual input during more sporty maneuvers, to directly reach compensatory neuroplastic sequelae after injury and to function in a functional way to train the neuromuscular system.This technological innovation makes this possible by reducing the visual input without completely eliminating it.This innovation, called stroboscopic goggles technology, provides a mechanism to disrupt to any degree between eyes closed and open in the visual system.
Stroboscopic vision, characterized by intermittent vision obstruction, can be a clinical tool that allows clinicians to study sensory feedback in a progressive manner without fully seeing visual information. So use stroboscopic goggles to prevent visual information, you can improve the functionality by emphasizing the somatosensor information.In particular, visual manipulations can significantly influence the healthy adult electrocortical dynamics and balance control by triggering the contradiction between visual adult, vestibular and proprioceptive inputs.
The aim of this study, which was planned for this purpose, will be to evaluate the effects of neuromuscular exercises performed on stroboscopic environment on equilibrium, neural feedback and running mechanics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Neuromuscular TrainingNeuromuscular training will be performed in this group for 6 weeks. |
| Strobe Group | Experimental | Other: Neuromuscular Training, Other: Strobe GlassesThis group will perform neuromuscular training for 6 weeks with a strobe glasses. |
| Control Group | No intervention | –This group will not perform any neuromuscular training program. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- To have at least 5 years active athletes in any sports branch.
- The first sprain history of individuals should be inflammatory symptoms (pain, swelling) at least 1 year before the study,
- Individuals should have unilateral ankle sprain,
- The newest sprain must have occurred 3 months before or after the date of commencement,
- Individuals must have at least 2 times a feeling of instability within 6 months,
Key exclusion criteria (9 listed)
- Individuals who are not active athletes for at least 5 years in any sports branch.
- First sprain history of individuals with inflammatory symptoms (pain, swelling) at least 1 year before the study.
- The absence of unilateral ankle sprain by individuals.
- The most recent buckling is that it did not take place 3 months before or after the date of commencement.
- Individuals should not have a feeling of instability for at least 2 times within 6 months.
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 |
|---|---|---|
| Neuromuscular TrainingThe experimental group will perform neuromuscular exercise for 6 weeks. The other experimental group will perform neuromuscular exercises with strobe glasses. | Other | Strobe Group, Training Group |
| Strobe GlassesStroboscopic glasses, which is characterized by intermittent vision obstruction, is a clinical tool that allows clinicians to examine sensory feedback in a progressive manner without fully seeing visual information. | Other | Strobe Group |
Primary outcome
FAAM (Foot and Ankle Ability Measure),
Time frame: 8 weeks
Pre-test evaluation will be done. After the end of neuromuscular training for 6 weeks, the final test will be evaluated. This value will be saved as %.
Ankle ROM
Time frame: 2 weeks
The two bars of Optojump are placed on the treadmill with a speed of 3.5m / sec and the foot strokes, imbalance and heel strokes will be recorded and the normal joint movements of the ankle with the Myo-motion device will be recorded.
Balance
Time frame: 2 weeks
Static and dynamic balances of athletes before and after neuromuscular training will be evaluated. Center of pressure area (COP) foot pressure point shall be evaluated in mm. And İt is defined as a measure indicative of the time and/or distance a subject spent away from a central point.
EEG (Electroencephalography)
Time frame: 2 weeks
The theta and beta waveform of EEG values of people will be measured during the static and dynamic balance evaluation.
FAAM-S (Foot and Ankle Ability Measure Sport Scale)
Time frame: 8 weeks
Pre-test evaluation will be done. After the end of neuromuscular training for 6 weeks, the final test will be evaluated. The Sports subscale is scored the same as FAAM (Foot and Ankle Ability Measure) 4 being 'no difficulty at all' to 0 being 'unable to do'. The score on each item are added together to get the item score total. The number of items with a response is multiplied by 4 to get the highest potential score. If the subject answers all 8 items the highest potential score is 32, if one item is not answered the highest potential score is 28, if two are not answered the highest potential score is 24, etc. The item score total is divided by the highest potential score. This value is multiplied by 100 to get a percentage. A higher score represents a higher level of physical function.
BMI (Body Mass Index)
Time frame: 2 weeks
Body mass index will be calculated before neuromuscular training. It will be evaluated in kg/m2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Serkan UZLAŞIR study director
Nevşehir Hacı Bektaş Veli University Sports Science Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Training and Strobe Glasses in people with Ankle Injuries, run by Hacettepe 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 10 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FAAM (Foot and Ankle Ability Measure), (time frame: 8 weeks). The study lists 6 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 10 Dec 2019.