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Effects of Progressive Exercise Method Using Balance Board in Recreational Athletes With Functional Ankle Instability

Primary Purpose

Ankle Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Game-Based Exercises
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ankle Injuries focused on measuring ankle instability, game-based exercises, postural balance, physical performance, recreational athletes

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participating recreational sports and doing at least 1.5 hours of cardiovascular or resistance training per week, History of one or more ankle sprains, Functional Ankle Instability Definition (FABIT) score >11, Having experienced a sprain/loss of instability in the last 6 months, Volunteering to attend the study. Exclusion Criteria: History of an active injury in both lower extremities, History of surgery or fracture in both lower extremities, Visual, auditory and vestibular problems, Neurological and rheumatologic diseases.

Sites / Locations

  • Acıbadem Mehmet Ali Aydınlar UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

Game-based balance exercises on BoBo Home Balance Board

Outcomes

Primary Outcome Measures

Star Excursion Balance Test
Straight lines are drawn on the floor in anterior, posterior, posterolateral and posteromedial directions. The individual is in the middle of these directions with the leg with instability on the floor. The other leg is asked to reach in these directions. The individual is asked to reach each of these four directions three times and the average is taken.
Foot and Ankle Ability Measure
The Ankle Foot and Ankle Usability Measure consists of 21-questions and 2 subscales (activity of daily living (ADL) subscale and sportive activity subscale). In response to the questions, individuals are asked to mark one of the options "not difficult at all", "slightly difficult", "moderately difficult", "extremely difficult", "unable to do", "not applicable". The total score of the 21-question daily life activity section ranges from 0-84, and the total score of the 8-question sportive activity section ranges from 0-32. A higher score represents a higher functioning of each subscale. In addition, at the end of each subscale, individuals are asked to indicate their function between 0-100%. 100% indicates pre-instability function.

Secondary Outcome Measures

Foot Lift Test
The individual is positioned so that the leg with instability is on the floor and the other leg is slightly flexed at the hip and knee (standing on one leg). For 30 seconds, the number of times he/she lifts the foot on the ground (e.g. lifting the toes) (including touching the opposite foot to the ground) will be tested. Three trials will be made and averaged.
Static Balance
The individual is positioned with the leg with instability on the ground and the other leg slightly flexed at the hip and knee (standing on one leg). How many seconds the individual can balance with eyes closed is measured with a stopwatch. Three trials are performed. The longest time will be evaluated. The maximum time is determined as 60 seconds.
8 Figure Jump Test
On a 5-meter-long track, the individual is asked to complete the track by jumping with the foot with instability on a path drawn in 8 shapes. It will be checked how many seconds it takes to complete the course with a stopwatch. They will be asked to make two attempts and the shortest time will be evaluated.
Side Jump Test
The individual is asked to jump 10 times with the foot with instability, 30 cm laterally and 30 cm medially. The time it takes to complete the jump is measured with a stopwatch. The individual is asked to try twice and the shortest time will be evaluated.
Short Form-12 Quality of Life Scale
It is a twelve-item questionnaire drawn from the eight subscales of the SF-36. It assesses two general health constructs: physical and mental components. All summary scores range from 0 to 100, where higher scores indicate better quality of life.
Fear-Avoidance Beliefs Questionnaire
This questionnaire can be used to assess individuals' fear-avoidance beliefs after instability. It includes an 11-question assessment. The total score ranges from 0-66. The higher the score, the higher the fear avoidance belief.
Enjoyment of Physical Activities Scale
This questionnaire aims to assess the enjoyment of the exercises in the intervention by the individuals in the study. The questionnaire consists of eight questions and each question has a score between "1-7". It is expressed as "1: strongly disagree" and "7: strongly agree". A high score indicates enjoyment of physical activity.
Global Rating of Change Scale
Individuals will be asked to mark one of the numbers "-2 -1 0 +1 +2" on a linear line to evaluate satisfaction after 4 weeks of intervention. "-2: very bad", "-1: bad", "0: same", "+1: good", "+2: very good.

Full Information

First Posted
September 11, 2023
Last Updated
September 15, 2023
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT06041243
Brief Title
Effects of Progressive Exercise Method Using Balance Board in Recreational Athletes With Functional Ankle Instability
Official Title
Effects of Progressive Exercise Method Using Balance Board in Recreational Athletes With Functional Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem 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
Ankle sprains are common injuries in physically active individuals who are involved in sports such as soccer and volleyball. It is also frequently seen in sedentary individuals who are not physically active and in people who engage in recreational sports. The recurrence rate of lateral ankle sprains has been shown to be 80%. Functional Ankle Instability can be defined as recurrent ankle sprain and/or a "giving away sensation" happens after the initial sprain. Conservative treatments are recommended to prevent recurrent injuries and to return to activity after stability, since the group that usually experiences a feeling of stability consists of young people. As a treatment, sensory and cognitive notifications and exercise applications that involve progression by increasingly challenging the individual, including reducing the support surface and changing the center of gravity, are recommended. The Balance Board is a simple, cheap and applicable tool used to improve balance in treatment. In addition to improving balance, it reduces ankle sprains by up to 50%. The balance board can train the ankle unidirectionally or multiaxially. Unidirectional balance usually allows uniaxial movement based on a flat wood and a semicircle underneath. Multiaxial balance board systems are systems that allow multi-directional movement in all axes regardless of the position of the foot. It was reported that the performance gained as a result of the use of the multiaxial balance board was long-lasting and showed a rapid recovery in injuries. It has been concluded that balance training with a balance board restores the normal neuromuscular feedback loop by improving mechanoreceptor function, which contributes to the retraining of the sensorimotor system. The use of game elements in treatment is defined as gamification and is a cheap and alternative method to perform various medical procedures. The increasing interest in gamification is due to lack of compliance with traditional treatment, increase in health care costs and inequitable access to health care. Musculoskeletal disorders are one of the leading causes of physical disability worldwide and gamification can be useful in various musculoskeletal rehabilitation such as tendonitis, degenerative joint disorders, neural compressions. Games are more attractive to patients and provide therapists with a wide range of alternatives for rehabilitation, making the treatment more dynamic and attractive. The aim of our study was to investigate the effects of the exercise method on ankle stability, ankle functionality and enjoyment level of exercise in individuals with functional ankle instability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries
Keywords
ankle instability, game-based exercises, postural balance, physical performance, recreational athletes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Game-based balance exercises on BoBo Home Balance Board
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Game-Based Exercises
Intervention Description
Exercises aimed to improve postural balance with four different games
Primary Outcome Measure Information:
Title
Star Excursion Balance Test
Description
Straight lines are drawn on the floor in anterior, posterior, posterolateral and posteromedial directions. The individual is in the middle of these directions with the leg with instability on the floor. The other leg is asked to reach in these directions. The individual is asked to reach each of these four directions three times and the average is taken.
Time Frame
4 weeks
Title
Foot and Ankle Ability Measure
Description
The Ankle Foot and Ankle Usability Measure consists of 21-questions and 2 subscales (activity of daily living (ADL) subscale and sportive activity subscale). In response to the questions, individuals are asked to mark one of the options "not difficult at all", "slightly difficult", "moderately difficult", "extremely difficult", "unable to do", "not applicable". The total score of the 21-question daily life activity section ranges from 0-84, and the total score of the 8-question sportive activity section ranges from 0-32. A higher score represents a higher functioning of each subscale. In addition, at the end of each subscale, individuals are asked to indicate their function between 0-100%. 100% indicates pre-instability function.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Foot Lift Test
Description
The individual is positioned so that the leg with instability is on the floor and the other leg is slightly flexed at the hip and knee (standing on one leg). For 30 seconds, the number of times he/she lifts the foot on the ground (e.g. lifting the toes) (including touching the opposite foot to the ground) will be tested. Three trials will be made and averaged.
Time Frame
4 weeks
Title
Static Balance
Description
The individual is positioned with the leg with instability on the ground and the other leg slightly flexed at the hip and knee (standing on one leg). How many seconds the individual can balance with eyes closed is measured with a stopwatch. Three trials are performed. The longest time will be evaluated. The maximum time is determined as 60 seconds.
Time Frame
4 weeks
Title
8 Figure Jump Test
Description
On a 5-meter-long track, the individual is asked to complete the track by jumping with the foot with instability on a path drawn in 8 shapes. It will be checked how many seconds it takes to complete the course with a stopwatch. They will be asked to make two attempts and the shortest time will be evaluated.
Time Frame
4 weeks
Title
Side Jump Test
Description
The individual is asked to jump 10 times with the foot with instability, 30 cm laterally and 30 cm medially. The time it takes to complete the jump is measured with a stopwatch. The individual is asked to try twice and the shortest time will be evaluated.
Time Frame
4 weeks
Title
Short Form-12 Quality of Life Scale
Description
It is a twelve-item questionnaire drawn from the eight subscales of the SF-36. It assesses two general health constructs: physical and mental components. All summary scores range from 0 to 100, where higher scores indicate better quality of life.
Time Frame
4 weeks
Title
Fear-Avoidance Beliefs Questionnaire
Description
This questionnaire can be used to assess individuals' fear-avoidance beliefs after instability. It includes an 11-question assessment. The total score ranges from 0-66. The higher the score, the higher the fear avoidance belief.
Time Frame
4 weeks
Title
Enjoyment of Physical Activities Scale
Description
This questionnaire aims to assess the enjoyment of the exercises in the intervention by the individuals in the study. The questionnaire consists of eight questions and each question has a score between "1-7". It is expressed as "1: strongly disagree" and "7: strongly agree". A high score indicates enjoyment of physical activity.
Time Frame
4 weeks
Title
Global Rating of Change Scale
Description
Individuals will be asked to mark one of the numbers "-2 -1 0 +1 +2" on a linear line to evaluate satisfaction after 4 weeks of intervention. "-2: very bad", "-1: bad", "0: same", "+1: good", "+2: very good.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participating recreational sports and doing at least 1.5 hours of cardiovascular or resistance training per week, History of one or more ankle sprains, Functional Ankle Instability Definition (FABIT) score >11, Having experienced a sprain/loss of instability in the last 6 months, Volunteering to attend the study. Exclusion Criteria: History of an active injury in both lower extremities, History of surgery or fracture in both lower extremities, Visual, auditory and vestibular problems, Neurological and rheumatologic diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özgül Öztürk, PhD
Phone
902165004185
Email
ozgul.ozturk@acibadem.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Behiç Turhan
Phone
905323159888
Email
behic.turhan@live.acibadem.edu.tr
Facility Information:
Facility Name
Acıbadem Mehmet Ali Aydınlar University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özgül Öztürk, PhD
Phone
2165004185
Email
ozgul.ozturk@acibadem.edu.tr
First Name & Middle Initial & Last Name & Degree
Behiç Turhan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Progressive Exercise Method Using Balance Board in Recreational Athletes With Functional Ankle Instability

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