KinesiophobiaNCT05602233
The Effect of Balance Training Following STARS on Postural Control
A study testing Exercise and STARS (Sensory-Targeted Ankle Rehabilitation Strategies) in people with Kinesiophobia and Ankle Sprains, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Chronic ankle instability (CAI) is defined as the symptoms continuing 12 months after the first sprain and the functional and/or mechanical instability reported by the individual. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Kinesiophobia, Ankle Sprains, Sensory Deficit
- What is being tested?
- Exercise and STARS (Sensory-Targeted Ankle Rehabilitation Strategies)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 30 Jan 2023
- 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
- History of first ankle sprain more than 1 year ago
- Having at least 2 "give away" episodes in the last 6 months
- Identification of Functional Ankle Instability's score above 11
- 18-25 age range
- Foot and Ankle Ability Measure (FAAM), the score of which is less than %90
- Foot and Ankle Ability Measure Sports scale (FAAM-S), the score of which is less than %80
Who cannot join
- History of lower extremity surgery
- History of disease that may affect sensorimotor function in the lower extremity
- Musculoskeletal disorders that may affect balance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir University
Beşiktaş, Istanbul, 34353
About this study
Official title: The Effect of Balance Training Following STARS on Postural Control and Function in Athletes With Chronic Ankle Instability
Chronic ankle instability (CAI) is defined as the symptoms continuing 12 months after the first sprain and the functional and/or mechanical instability reported by the individual. The number of researches that include a combined treatment approach that will affect both sensory and motor components in rehabilitation strategies applied for CAI is limited.
The aim of this study is to isolated sensory, isolated motor and combined targeted approaches for the treatment of chronic ankle instability (CAI); to compare the effects on postural control, range of motion, function and kinesiophobia and to contribute to an effective approach related to the applicability of Sensory-Targeted Ankle Rehabilitation Strategies in the treatment of CAI.
Read the detailed description
Lateral ankle sprains are among the most common injuries in athletes and physically active individuals, accounting for 80% of ankle injuries. After the ankle is sprained for the first time, it becomes more prone to re-injury. Chronic ankle instability (CAI) is defined as the symptoms continuing 12 months after the first sprain and the functional and/or mechanical instability reported by the individual. Long-term ongoing CAI symptoms; It includes pain, swelling, give away that reduces the person's quality of life.
Symptoms of CAI include both motor and sensory aspects of the sensorimotor system. Despite sensory and motor deficits in sensorimotor control, researches on CAI rehabilitation have focused on either motor or sensory components. The number of researches that include a combined treatment approach that will affect both sensory and motor components in rehabilitation strategies applied for CAI is limited.
Sensory-Targeted Ankle Rehabilitation Strategies (STARS) and balance training have proven to be effective in relieving CAI-associated deficits. Although the effects of isolated STARS were positive, in a recent study, there was no statistically significant difference between the groups when the balance training given with STARS was compared with the balance training alone. However, the reason for the lack of difference between the groups may be the simultaneous application of both treatment protocols. In addition, the effects of the isolated use of the STARS combination in the treatment of CAI are still unclear and to our knowledge, there are no studies in this area.
The aim of this study is to isolated sensory, isolated motor and combined targeted approaches for the treatment of chronic ankle instability (CAI); to compare the effects on postural control, range of motion, function and kinesiophobia and to contribute to an effective approach related to the applicability of STARS in the treatment of CAI.
- Being tested
- Exercise, STARS (Sensory-Targeted Ankle Rehabilitation Strategies)
- Medical subject headings
- Kinesiophobia, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The training will be given for 6 weeks, 3 times a week for 20 minutes. This phased balance training program is based on the participant's ability to maintain a single limb posture while performing balance activities. The program includes: 1) hop to stabilization, 2) hop to stabilization and reach, 3) hop to stabilization box drill, 4) progressive single-limb stance balance activities with eyes open, and 5) progressive single-limb stance activities with eyes closed. Participants will be followed up with a physiotherapist and will be able to proceed to the next stage of the test after completing the previous level without errors.
STARS (Sensory-Targeted Ankle Rehabilitation Strategies)Other
STARS includes; joint mobilization, plantar massage and triceps surae stretching. The training will be given for 6 weeks, 3 times a week for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Balance training: | Experimental | It is planned to apply hop to stabilization exercises developed by Mckeon et al. The training will be given for 6 weeks, 3 times a week for 20 minutes. This phased balance training program is based on the participant's ability to maintain a single limb posture while performing balance activities. The program includes: 1) hop to stabilization, 2) hop to stabilization and reach, 3) hop to stabilization box drill, 4) progressive single-limb stance balance activities with eyes open, and 5) progressive single-limb stance activities with eyes closed. Participants will be followed up with a physiotherapist and will be able to proceed to the next stage of the test after completing the previous level without errors. Receives: Other: Exercise |
| STARS | Experimental | A combination of STARS developed by Mckeon et al. is planned for the STARS group. The training will be given for 6 weeks, 3 times a week for 5 minutes. STARS includes; joint mobilization, plantar massage and triceps surae stretching. Receives: Other: STARS (Sensory-Targeted Ankle Rehabilitation Strategies) |
| Combined Training | Experimental | Each participant in the combined training program will receive 4 weeks of balance training after 2 weeks of STARS treatment. STARS and hop to stabilization treatment protocol will be applied in the same way. Receives: Other: Exercise; Other: STARS (Sensory-Targeted Ankle Rehabilitation Strategies) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control evaluation change
Star excursion balance test (SEBT): The star excursion balance test is frequently used to evaluate the dynamic balance and postural control of the lower extremities. SEBT, is a test that measures the maximum reach of the individual by maintaining balance and performing a single-leg squat in lines drawn at 45 degrees intervals in eight different directions. The participant stands in the middle of the star shape with bare feet. For the starting position, the ankle should be stationary, the hands on the hips, and the participant should maintain the starting position throughout the test. The participant is asked to reach anteriorly, posteromedially and posterolaterally with the unstable ankle, make a light touch to the line, and rotate the outstretched leg back to the center while maintaining a one-leg stance with the other leg.The participant will be allowed to make 4 trials in each direction
Measured: Change from Baseline postural control at 6 weeks
Secondary outcomes (3)
Ankle dorsiflexion measurement change
Weight-bearing lunge test (WBLT) is frequently used in individuals with ankle instability in order to determine dorsiflexion normal joint movement. During WBLT the participant puts his hands on the wall and takes one leg forward and the other leg helps balance behind. The maximum distance that the knee touches the wall is recorded without allowing the heel of the front foot to lose contact with the ground.
Measured: Change from baseline ankle dorsiflexion measurement at 6 weeks
Function change
The Foot and Ankle Ability Measure is used to assess self-reported overall function levels in patients with leg, ankle, and foot musculoskeletal injuries and disorders. It consists of 2 subscales (Activities of Daily Living [ADL] and Sports [S]), both scored between 0% and 100%. The FAAM-ADL is a 21-item scale to assess function during activities of daily living. FAAM-Sport is an 8-item scale focusing on sports-related activities. Items in both tools are scored on a 5-point Likert scale ranging from 0 (no difficulty at all) to 4 (I can't do it). Scores are converted to percentages, and a higher percentage indicates a better level of function.
Measured: Change from baseline ankle function measurement at 6 weeks
Kinesiophobia change
The Tampa kinesiophobia scale is often used in musculoskeletal injuries. TKS has a checklist of 17 questions. A 4-point Likert scoring (1= I strongly disagree, 4= I totally agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Measured: Change from baseline kinesiophobia measurement at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Nov 2022
- Primary completion1 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KinesiophobiaStudies 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
- Participants between the ages of 18-25, diagnosed with chronic ankle sprain who met the inclusion criteria will be included in the study. Sample size of the study is calculated as 21. All evaluations of the participants, including postural control, weight bearing dorsiflexion angle measurement, function and kinesiophobia will be made by the same physiotherapist. The physiotherapist who made the evaluations will not know which treatment method will be applied to the participants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Collaborators
- Nevsehir Haci Bektas Veli University
- Responsible party
- Principal investigator, Pelin Pişirici, Bahçeşehir University
- Investigators
- Pelin Pişirici, PhD, PT, Study chair, Bahçeşehir University, Faculty of Health Sciences, Physiotherapy and Rehabilitation DepartmentSerkan Uzlaşır, PhD, PT, Study director, Nevsehir Haci Bektas Unıversity, Faculty of Sports Sciences, Department of Coaching EducationAynur Merve Zümre, PT, Principal investigator, Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602233
- Sponsor's protocol ID
- Ankle-BAU&HBU-20221012
- Status last verified
- Jan 2023
- First submitted
- 26 Oct 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- 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 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Balance Training Following STARS on Postural Control and Function in Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT05602233
- Acronym / sponsor ID
- Ankle-BAU&HBU-20221012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Collaborators
- Nevsehir Haci Bektas Veli University
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 2 Nov 2022 (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.
Chronic ankle instability (CAI) is defined as the symptoms continuing 12 months after the first sprain and the functional and/or mechanical instability reported by the individual. The number of researches that include a combined treatment approach that will affect both sensory and motor components in rehabilitation strategies applied for CAI is limited.
The aim of this study is to isolated sensory, isolated motor and combined targeted approaches for the treatment of chronic ankle instability (CAI); to compare the effects on postural control, range of motion, function and kinesiophobia and to contribute to an effective approach related to the applicability of Sensory-Targeted Ankle Rehabilitation Strategies in the treatment of CAI.
Detailed description
Lateral ankle sprains are among the most common injuries in athletes and physically active individuals, accounting for 80% of ankle injuries. After the ankle is sprained for the first time, it becomes more prone to re-injury. Chronic ankle instability (CAI) is defined as the symptoms continuing 12 months after the first sprain and the functional and/or mechanical instability reported by the individual. Long-term ongoing CAI symptoms; It includes pain, swelling, give away that reduces the person's quality of life.
Symptoms of CAI include both motor and sensory aspects of the sensorimotor system. Despite sensory and motor deficits in sensorimotor control, researches on CAI rehabilitation have focused on either motor or sensory components. The number of researches that include a combined treatment approach that will affect both sensory and motor components in rehabilitation strategies applied for CAI is limited.
Sensory-Targeted Ankle Rehabilitation Strategies (STARS) and balance training have proven to be effective in relieving CAI-associated deficits. Although the effects of isolated STARS were positive, in a recent study, there was no statistically significant difference between the groups when the balance training given with STARS was compared with the balance training alone. However, the reason for the lack of difference between the groups may be the simultaneous application of both treatment protocols. In addition, the effects of the isolated use of the STARS combination in the treatment of CAI are still unclear and to our knowledge, there are no studies in this area.
The aim of this study is to isolated sensory, isolated motor and combined targeted approaches for the treatment of chronic ankle instability (CAI); to compare the effects on postural control, range of motion, function and kinesiophobia and to contribute to an effective approach related to the applicability of STARS in the treatment of CAI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants between the ages of 18-25, diagnosed with chronic ankle sprain who met the inclusion criteria will be included in the study. Sample size of the study is calculated as 21. All evaluations of the participants, including postural control, weight bearing dorsiflexion angle measurement, function and kinesiophobia will be made by the same physiotherapist. The physiotherapist who made the evaluations will not know which treatment method will be applied to the participants.
| Arm | Type | Receives |
|---|---|---|
| Balance training: | Experimental | Other: ExerciseIt is planned to apply hop to stabilization exercises developed by Mckeon et al. The training will be given for 6 weeks, 3 times a week for 20 minutes. This phased balance training program is based on the participant's ability to maintain a single limb posture while performing balance activities. The program includes: 1) hop to stabilization, 2) hop to stabilization and reach, 3) hop to stabilization box drill, 4) progressive single-limb stance balance activities with eyes open, and 5) progressive single-limb stance activities with eyes closed. Participants will be followed up with a physiotherapist and will be able to proceed to the next stage of the test after completing the previous level without errors. |
| STARS | Experimental | Other: STARS (Sensory-Targeted Ankle Rehabilitation Strategies)A combination of STARS developed by Mckeon et al. is planned for the STARS group. The training will be given for 6 weeks, 3 times a week for 5 minutes. STARS includes; joint mobilization, plantar massage and triceps surae stretching. |
| Combined Training | Experimental | Other: Exercise, Other: STARS (Sensory-Targeted Ankle Rehabilitation Strategies)Each participant in the combined training program will receive 4 weeks of balance training after 2 weeks of STARS treatment. STARS and hop to stabilization treatment protocol will be applied in the same way. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- History of first ankle sprain more than 1 year ago
Key exclusion criteria (3 listed)
- History of lower extremity surgery
- History of disease that may affect sensorimotor function in the lower extremity
- Musculoskeletal disorders that may affect balance
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 |
|---|---|---|
| ExerciseThe training will be given for 6 weeks, 3 times a week for 20 minutes. This phased balance training program is based on the participant's ability to maintain a single limb posture while performing balance activities. The program includes: 1) hop to stabilization, 2) hop to stabilization and reach, 3) hop to stabilization box drill, 4) progressive single-limb stance balance activities with eyes open, and 5) progressive single-limb stance activities with eyes closed. Participants will be followed up with a physiotherapist and will be able to proceed to the next stage of the test after completing the previous level without errors. | Other | Balance training:, Combined Training |
| STARS (Sensory-Targeted Ankle Rehabilitation Strategies)STARS includes; joint mobilization, plantar massage and triceps surae stretching. The training will be given for 6 weeks, 3 times a week for 5 minutes. | Other | Combined Training, STARS |
Primary outcome
Postural control evaluation change
Time frame: Change from Baseline postural control at 6 weeks
Star excursion balance test (SEBT): The star excursion balance test is frequently used to evaluate the dynamic balance and postural control of the lower extremities. SEBT, is a test that measures the maximum reach of the individual by maintaining balance and performing a single-leg squat in lines drawn at 45 degrees intervals in eight different directions. The participant stands in the middle of the star shape with bare feet. For the starting position, the ankle should be stationary, the hands on the hips, and the participant should maintain the starting position throughout the test. The participant is asked to reach anteriorly, posteromedially and posterolaterally with the unstable ankle, make a light touch to the line, and rotate the outstretched leg back to the center while maintaining a one-leg stance with the other leg.The participant will be allowed to make 4 trials in each direction
3 secondary outcomes
Ankle dorsiflexion measurement change
Time frame: Change from baseline ankle dorsiflexion measurement at 6 weeks
Function change
Time frame: Change from baseline ankle function measurement at 6 weeks
Kinesiophobia change
Time frame: Change from baseline kinesiophobia measurement at 6 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 31 Jan 2023.
- 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.
Pelin Pişirici, PhD, PT study chair
Bahçeşehir University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Serkan Uzlaşır, PhD, PT study director
Nevsehir Haci Bektas Unıversity, Faculty of Sports Sciences, Department of Coaching Education
Aynur Merve Zümre, PT principal investigator
Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and STARS (Sensory-Targeted Ankle Rehabilitation Strategies) in people with Kinesiophobia and Ankle Sprains, run by Bahçeşehir 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 6 inclusion and 3 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 31 Jan 2023. 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?
Postural control evaluation change (time frame: Change from Baseline postural control at 6 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 31 Jan 2023.