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The Effect of Visual Input in Athletes With Chronic Ankle Instability

Primary Purpose

Ankle Injuries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neuromuscular Training
Strobe Glasses
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ankle Injuries focused on measuring balance, chronic ankle instability, function, running

Eligibility Criteria

18 Years - 23 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. To have at least 5 years active athletes in any sports branch.
  2. The first sprain history of individuals should be inflammatory symptoms (pain, swelling) at least 1 year before the study,
  3. Individuals should have unilateral ankle sprain,
  4. The newest sprain must have occurred 3 months before or after the date of commencement,
  5. Individuals must have at least 2 times a feeling of instability within 6 months,
  6. Individuals should not have any ankle fractures in the past
  7. Individuals should have undergone no surgical procedure to affect the sensorimotor function in the lower extremity.
  8. IDFAI (Identification of Functional Ankle Instability Questionare) score is above 11,
  9. FAAM (Foot and Ankle Ability Measure) score less than 90%,
  10. FAAM-S (Foot and Ankle Ability Measure Sport Scale) score should be less than 80%.

Exclusion Criteria:

  1. Individuals who are not active athletes for at least 5 years in any sports branch.
  2. First sprain history of individuals with inflammatory symptoms (pain, swelling) at least 1 year before the study.
  3. The absence of unilateral ankle sprain by individuals.
  4. The most recent buckling is that it did not take place 3 months before or after the date of commencement.
  5. Individuals should not have a feeling of instability for at least 2 times within 6 months.
  6. People experience ankle fractures in the past.
  7. Individuals have undergone surgery to affect the sensorimotor function in the lower extremity.
  8. IDFAI (Identification of Functional Ankle Questionability) score not more than 11.
  9. 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%.

Sites / Locations

  • Serkan UZLAŞIR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Training Group

Strobe Group

Control Group

Arm Description

Neuromuscular training will be performed in this group for 6 weeks.

This group will perform neuromuscular training for 6 weeks with a strobe glasses.

This group will not perform any neuromuscular training program.

Outcomes

Primary Outcome Measures

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 %.
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.
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.
EEG (Electroencephalography)
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)
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)
Body mass index will be calculated before neuromuscular training. It will be evaluated in kg/m2.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2019
Last Updated
December 7, 2019
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03872973
Brief Title
The Effect of Visual Input in Athletes With Chronic Ankle Instability
Official Title
The Effect of Visual Input on Balance, Neural Feedback, Function and Running Mechanics in Athletes With Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
October 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries
Keywords
balance, chronic ankle instability, function, running

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training Group
Arm Type
Experimental
Arm Description
Neuromuscular training will be performed in this group for 6 weeks.
Arm Title
Strobe Group
Arm Type
Experimental
Arm Description
This group will perform neuromuscular training for 6 weeks with a strobe glasses.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will not perform any neuromuscular training program.
Intervention Type
Other
Intervention Name(s)
Neuromuscular Training
Intervention Description
The experimental group will perform neuromuscular exercise for 6 weeks. The other experimental group will perform neuromuscular exercises with strobe glasses.
Intervention Type
Other
Intervention Name(s)
Strobe Glasses
Intervention Description
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.
Primary Outcome Measure Information:
Title
FAAM (Foot and Ankle Ability Measure),
Description
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 %.
Time Frame
8 weeks
Title
Ankle ROM
Description
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.
Time Frame
2 weeks
Title
Balance
Description
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.
Time Frame
2 weeks
Title
EEG (Electroencephalography)
Description
The theta and beta waveform of EEG values of people will be measured during the static and dynamic balance evaluation.
Time Frame
2 weeks
Title
FAAM-S (Foot and Ankle Ability Measure Sport Scale)
Description
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.
Time Frame
8 weeks
Title
BMI (Body Mass Index)
Description
Body mass index will be calculated before neuromuscular training. It will be evaluated in kg/m2.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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%. Exclusion Criteria: 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. 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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serkan UZLAŞIR
Organizational Affiliation
Nevşehir Hacı Bektaş Veli University Sports Science Laboratory
Official's Role
Study Director
Facility Information:
Facility Name
Serkan UZLAŞIR
City
Nevşehir
State/Province
Merkez
ZIP/Postal Code
50300
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Visual Input in Athletes With Chronic Ankle Instability

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