Ankle InjuriesNCT06041243
Effects of Progressive Exercise Method Using Balance Board in Recreational Athletes With Functional Ankle Instability
A study testing Game-Based Exercises in people with Ankle Injuries, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Game-Based Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2023to 15 Feb 2024
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Mehmet Ali Aydınlar University
Istanbul
About this study
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.
Read more
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.
- Conditions
- Ankle Injuries
- Being tested
- Game-Based Exercises
- Keywords
- ankle instability, game-based exercises, postural balance, physical performance, recreational athletes
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-Based ExercisesOther
Exercises aimed to improve postural balance with four different games
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Game-based balance exercises on BoBo Home Balance Board Receives: Other: Game-Based Exercises |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Star Excursion Balance Test
Straight lines are drawn on the floor in anterior, 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.
Measured: 4 weeks
Secondary outcomes (9)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start11 Sep 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
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 Acibadem 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041243
- Sponsor's protocol ID
- ATADEK 2023-10/347
- Status last verified
- Jun 2024
- First submitted
- 11 Sep 2023
- Last updated
- 4 Jun 2024
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Exercise Method Using Balance Board in Recreational Athletes With Functional Ankle Instability
- ClinicalTrials.gov ID
- NCT06041243
- Acronym / sponsor ID
- ATADEK 2023-10/347
- Conditions
- Ankle Injuries
- Keywords
- ankle instability, game-based exercises, postural balance, physical performance, recreational athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 18 Sep 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Game-Based ExercisesGame-based balance exercises on BoBo Home Balance Board |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Game-Based ExercisesExercises aimed to improve postural balance with four different games | Other | Treatment |
Primary outcome
Star Excursion Balance Test
Time frame: 4 weeks
Straight lines are drawn on the floor in anterior, 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.
9 secondary outcomes
Foot Lift Test
Time frame: 4 weeks
Static Balance
Time frame: 4 weeks
8 Figure Jump Test
Time frame: 4 weeks
Side Jump Test
Time frame: 4 weeks
Short Form-12 Quality of Life Scale
Time frame: 4 weeks
Fear-Avoidance Beliefs Questionnaire
Time frame: 4 weeks
Enjoyment of Physical Activities Scale
Time frame: 4 weeks
Global Rating of Change Scale
Time frame: 4 weeks
Foot and Ankle Ability Measure
Time frame: 4 weeks
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 4 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Ankle Injuries
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
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
RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Syndesmotic Injury, Trimalleolar Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game-Based Exercises in people with Ankle Injuries, run by Acibadem 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 5 inclusion and 4 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 4 Jun 2024. 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?
Star Excursion Balance Test (time frame: 4 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 4 Jun 2024.