Ankle InjuriesNCT04139044
The Effects of Unilateral Balance Training Among Athletes With Chronic Ankle Instability
A study testing Balance Exercise Training for Stable Ankle and Balance Exercise Training for Unstable Ankle in people with Ankle Injuries and Ankle Sprains, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the effects of a 4-week, unilateral balance exercise training program on bilateral balance and explosive power in athletes with chronic ankle instability. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries, Ankle Sprains
- What is being tested?
- Balance Exercise Training for Stable Ankle and Balance Exercise Training for Unstable Ankle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2019to 18 Dec 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participating in the study on a voluntary basis
- Athletes with 18-25 years old
- Being a player in one of the basketball, volleyball, and handball team sports
- Athletes with a history of at least 2 significant lateral ankle sprains which were classified as a second degree and related to inflammatory symptoms (pain, swelling)
- The self-reported sensation of giving away and instability at the injured ankle confirmed by the Cumberland Ankle Instability Tool with a score ≤25
- Recurrent lateral ankle sprain episodes of the injured ankle occurred at least 12 months
- The self-reported function of the injured ankle confirmed by Foot and Ankle Ability Measure with a score <90% from activities of daily living subscale and <80% from sport subscale.
Who cannot join
- A history of surgery to the musculoskeletal structures in either lower extremity
- A history of a fracture in either lower extremity necessitating realignment
- Acute injury of musculoskeletal structures of other joints of the lower extremity in the previous 3 months affecting joint function and integrity
- Presence of bilateral ankle instability
- Balance or vestibular disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Unilateral Balance Training on Bilateral Balance and Explosive Power Among Athletes With Chronic Ankle Instability
The aim of the study is to investigate the effects of a 4-week, unilateral balance exercise training program on bilateral balance and explosive power in athletes with chronic ankle instability. The participants were randomly divided into Stable Ankle Training Group (SG) (n=9), Unstable Ankle Training Group (UG) (n=9) and control group (CG) (n=10). The balance exercise training program was administered for only the stable ankle of athletes in SG and only the unstable ankle of athletes in UG, twice a week and for a 4-week duration.
Read the detailed description
The aim of the study is to investigate the effects of a 4-week, unilateral balance exercise training program on bilateral balance and explosive power in athletes with chronic ankle instability (CAI). The study included 28 volunteer athletes with a history of CAI who registered as a team player at Yeditepe University Culture and Sports Directorate February 2019 - June 2019. The severity of functional ankle instability of all the athletes was assessed by the Cumberland Ankle Instability Tool (CAIT). Functional limitations of the athletes with CAI were evaluated by Foot and Ankle Ability Measure Activity of Daily Living Subscale (FAAM-ADL) and Sports Subscale (FAAM-S). Balance Error Scoring System (BESS) was used to determine the static balance performance of athletes. Dynamic balance was evaluated by the Y Balance Test (YBT). Sport performance including vertical jumping and hopping was assessed with Single-Legged Countermovement Jump (CMJ) Test, Figure-of-Eight Hop Test, and Side Hop Test. The athletes were randomly divided into Rehabilitation for the Stable Ankle Group (SG) (n=9), Rehabilitation for the Unstable Ankle Group (UG) (n=9) and Control Group (CG) (n=10). Athletes in SG and UG were included balance exercise training program. The balance exercise training program was administered for only the stable ankle of athletes in SG and only the unstable ankle of athletes in UG, twice a week and for a 4-week duration.
- Conditions
- Ankle Injuries, Ankle Sprains
- Being tested
- Balance Exercise Training for Stable Ankle, Balance Exercise Training for Unstable Ankle
- Keywords
- ankle, joint instability, cross-education, rehabilitation
- Medical subject headings
- Ankle Injuries, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance Exercise Training for Stable AnkleProcedure or surgery
Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.
Balance Exercise Training for Unstable AnkleProcedure or surgery
Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.
| Study group | Role | What they receive |
|---|---|---|
| Stable Ankle Training Group (SG) | Experimental | Balance Exercise Training for Only The Stable Ankle Receives: Procedure: Balance Exercise Training for Stable Ankle |
| Unstable Ankle Training Group (UG) | Experimental | Balance Exercise Training for Only The Unstable Ankle Receives: Procedure: Balance Exercise Training for Unstable Ankle |
| Control Group (CG) | No intervention | No balance exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and Ankle Ability Measure
The FAAM is a self-reported tool improved to evaluate the physical functions of individuals with musculoskeletal disorders related to foot and ankle.
Measured: 4 weeks
Balance Error Scoring System
The BESS is a valid test to find out deficits in static postural control of individuals with CAI.
Measured: 4 weeks
Y Balance Test
The Y Balance Test is the functional test that is able to find out impairments in dynamic postural control among individuals with CAI
Measured: 4 weeks
Single-Leg Countermovement Jump Test
The Single-LegCountermovement jump test is used to evaluate the lower-extremity power of athletes, and indirectly the functional performance.
Measured: 4 weeks
Figure-of-Eight Hop Test
Figure-of-8 Hop Test is used to measure the explosive power of the lower extremity of athletes.
Measured: 4 weeks
Side Hop Test
Side Hop test is a test used to evaluate the explosive power of the lower extremity of athletes.
Measured: 4 weeks
Secondary outcomes (1)
Cumberland Ankle Instability Tool
Cumberland Ankle Instability Tool including a 30-point scale of 9-items is a valid and reliable questionnaire for distinguishing and quantifying the severity of functional instability.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start18 Feb 2019
- Primary completion14 Nov 2019
- Study completion18 Dec 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.
- 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
- Parallel groups
- Model description
- The sample of the study consists of athletes with a history of CAI who registered as a team player at Yeditepe University Culture and Sports Directorate between February 2019 and June 2019.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayça Yağcıoğlu, MSc, Principal investigator, Yeditepe University, Health Sciences Faculty, Physiotherapy and RehabilitationGökhan Metin, Professor, Study chair, Istanbul University, Faculty of Medicine, Sports MedicineFeryal Subaşı, Professor, Study chair, Yeditepe University, Health Sciences Faculty, Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139044
- Sponsor's protocol ID
- YeditepeUptr
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Unilateral Balance Training on Bilateral Balance and Explosive Power Among Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT04139044
- Acronym / sponsor ID
- YeditepeUptr
- Conditions
- Ankle Injuries, Ankle Sprains
- Keywords
- ankle, joint instability, cross-education, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 25 Oct 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 the study is to investigate the effects of a 4-week, unilateral balance exercise training program on bilateral balance and explosive power in athletes with chronic ankle instability. The participants were randomly divided into Stable Ankle Training Group (SG) (n=9), Unstable Ankle Training Group (UG) (n=9) and control group (CG) (n=10). The balance exercise training program was administered for only the stable ankle of athletes in SG and only the unstable ankle of athletes in UG, twice a week and for a 4-week duration.
Detailed description
The aim of the study is to investigate the effects of a 4-week, unilateral balance exercise training program on bilateral balance and explosive power in athletes with chronic ankle instability (CAI). The study included 28 volunteer athletes with a history of CAI who registered as a team player at Yeditepe University Culture and Sports Directorate February 2019 - June 2019. The severity of functional ankle instability of all the athletes was assessed by the Cumberland Ankle Instability Tool (CAIT). Functional limitations of the athletes with CAI were evaluated by Foot and Ankle Ability Measure Activity of Daily Living Subscale (FAAM-ADL) and Sports Subscale (FAAM-S). Balance Error Scoring System (BESS) was used to determine the static balance performance of athletes. Dynamic balance was evaluated by the Y Balance Test (YBT). Sport performance including vertical jumping and hopping was assessed with Single-Legged Countermovement Jump (CMJ) Test, Figure-of-Eight Hop Test, and Side Hop Test. The athletes were randomly divided into Rehabilitation for the Stable Ankle Group (SG) (n=9), Rehabilitation for the Unstable Ankle Group (UG) (n=9) and Control Group (CG) (n=10). Athletes in SG and UG were included balance exercise training program. The balance exercise training program was administered for only the stable ankle of athletes in SG and only the unstable ankle of athletes in UG, twice a week and for a 4-week duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The sample of the study consists of athletes with a history of CAI who registered as a team player at Yeditepe University Culture and Sports Directorate between February 2019 and June 2019.
| Arm | Type | Receives |
|---|---|---|
| Stable Ankle Training Group (SG) | Experimental | Procedure: Balance Exercise Training for Stable AnkleBalance Exercise Training for Only The Stable Ankle |
| Unstable Ankle Training Group (UG) | Experimental | Procedure: Balance Exercise Training for Unstable AnkleBalance Exercise Training for Only The Unstable Ankle |
| Control Group (CG) | No intervention | –No balance exercise training |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participating in the study on a voluntary basis
- Athletes with 18-25 years old
- Being a player in one of the basketball, volleyball, and handball team sports
- Athletes with a history of at least 2 significant lateral ankle sprains which were classified as a second degree and related to inflammatory symptoms (pain, swelling)
- The self-reported sensation of giving away and instability at the injured ankle confirmed by the Cumberland Ankle Instability Tool with a score ≤25
Key exclusion criteria (5 listed)
- A history of surgery to the musculoskeletal structures in either lower extremity
- A history of a fracture in either lower extremity necessitating realignment
- Acute injury of musculoskeletal structures of other joints of the lower extremity in the previous 3 months affecting joint function and integrity
- Presence of bilateral ankle instability
- Balance or vestibular disorder
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 |
|---|---|---|
| Balance Exercise Training for Stable AnkleBalance and hop stabilization exercises were administered for 30 minutes of each exercise session. | Procedure or surgery | Stable Ankle Training Group (SG) |
| Balance Exercise Training for Unstable AnkleBalance and hop stabilization exercises were administered for 30 minutes of each exercise session. | Procedure or surgery | Unstable Ankle Training Group (UG) |
Primary outcome
Foot and Ankle Ability Measure
Time frame: 4 weeks
The FAAM is a self-reported tool improved to evaluate the physical functions of individuals with musculoskeletal disorders related to foot and ankle.
Balance Error Scoring System
Time frame: 4 weeks
The BESS is a valid test to find out deficits in static postural control of individuals with CAI.
Y Balance Test
Time frame: 4 weeks
The Y Balance Test is the functional test that is able to find out impairments in dynamic postural control among individuals with CAI
Single-Leg Countermovement Jump Test
Time frame: 4 weeks
The Single-LegCountermovement jump test is used to evaluate the lower-extremity power of athletes, and indirectly the functional performance.
Figure-of-Eight Hop Test
Time frame: 4 weeks
Figure-of-8 Hop Test is used to measure the explosive power of the lower extremity of athletes.
Side Hop Test
Time frame: 4 weeks
Side Hop test is a test used to evaluate the explosive power of the lower extremity of athletes.
1 secondary outcome
Cumberland Ankle Instability Tool
Time frame: Baseline
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 22 Oct 2020.
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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.
Ayça Yağcıoğlu, MSc principal investigator
Yeditepe University, Health Sciences Faculty, Physiotherapy and Rehabilitation
Gökhan Metin, Professor study chair
Istanbul University, Faculty of Medicine, Sports Medicine
Feryal Subaşı, Professor study chair
Yeditepe University, Health Sciences Faculty, Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Exercise Training for Stable Ankle and Balance Exercise Training for Unstable Ankle in people with Ankle Injuries and Ankle Sprains, 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 7 inclusion and 5 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 22 Oct 2020. 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?
Foot and Ankle Ability Measure (time frame: 4 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 22 Oct 2020.