Chronic Ankle InstabilityNCT07132840
Combined Effects of Balance Training and Taping in People With Functional Ankle Instability.
A study testing Kinesio tape application followed by single session of balance training on various unstable surfaces. in people with Chronic Ankle Instability and Functional Ankle Instability, run by St. John's Research Institute at 1 site in India.
Trial summary
Approximately 70% of all people who have had a simple ankle sprain tend to develop continuing instability and pain. Chronic ankle instability is the most common problem that impairs the patients' daily functions. This can lead to balance issues, chances of recurrent sprain and loss of function. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Chronic Ankle Instability, Functional Ankle Instability, Lateral Ankle Sprain
- What is being tested?
- Kinesio tape application followed by single session of balance training on various unstable surfaces.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 21 Sep 2023to 25 Jan 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
- Adults between the age of 18 - 40 years with a history of at least 1 ankle sprain
- Cumberland Ankle Instability Test score of ≤ 27 indicative of Functional Ankle instability
- No episode of an ankle sprain in the past 3 months
- No history of limb fracture in the past 6 months prior to study
- Absence of vestibular disorders or concussion symptoms
- No history of any neuromuscular disorders
Who cannot join
- Health issue that would interfere with participants safety during exercise
- Participants with active malignancy, cellulitis, skin infection, or open wound.
- Presence of common cold.
- After Inclusion in study:
- Participants excluded if they missed the 24 hours follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Balance Training Combined With Kinesio-taping on Static Balance, Dynamic Balance and Proprioception in People With Functional Ankle Instability (FAI)- A Quasi-experimental Study
Approximately 70% of all people who have had a simple ankle sprain tend to develop continuing instability and pain. Chronic ankle instability is the most common problem that impairs the patients' daily functions. This can lead to balance issues, chances of recurrent sprain and loss of function.
- Therefore, the investigators are conducting this study to assess the immediate effects of balance exercises along with kinesio-taping on static balance, dynamic balance and joint position sense, and to also assess if this combination can be used as stopgap (quick-fix) to improve balance and proprioception before a session of sports activity in people involved in recreational sports.
- During the study, the participants will receive a one-time application of ankle kinesio-taping followed by an hour of balance training exercises on different surfaces such as Dynair, Bosu, Foam pads, and Mini tramp. Joint position sense will be assessed using a digital inclinometer that is already available in the department.
- The participants will be tested using certain physical tests to assess the static balance and dynamic balance using the Balance Error Scoring System tool and Star Excursion Balance Test respectively which they will perform before and 24 hours post training.
Read the detailed description
Ankle sprains account for approximately 85% of lower extremity injuries. Ankle sprains are often incorrectly considered to be harmless injuries with no lasting consequences, but in fact, reduced physical activity, patient reported disability, increased symptoms and risk of re-injury and recurrent injury are all commonly reported months and sometimes even years after the first sprain. Close to 70% of those who have suffered an ankle sprain develop ankle instability or "giving way" of the ankle during functional activities . There is also evidence suggesting that repetitive ankle sprains are a risk factor for ankle osteoarthritis. The initial injury may result in 2 types of dysfunctions, mechanical instability or functional instability, this influences the outcome by resulting in either i) recovery from the acute sprain or ii) development of chronic instability.
Functional Ankle Instability [FAI], refers to the sensorimotor and neurological deficits that accompany ligamentous injury. Functional Ankle Instability is used to describe the feeling of their ankle giving way, being more painful and being weaker specifically while performing some activity, compared to before the injury. Functional Ankle Instability has been difficult to measure reliably, until recently. Cumberland Ankle Instability Tool is a 9-item 30-point scale developed specifically to measure the severity of Functional Ankle Instability. The CAIT tool has an 83% sensitivity and 75% specificity . In the acute stage, use of the RICE (Rest, Ice, Compression, and Elevation) protocol is recommended to decrease edema, followed by electro modalities such as electrostimulation, ultrasonic therapy, massage, and manual therapy to decrease pain and speed functional recovery .
The essence of evidence-based practice lies in the effectiveness of the treatment that is being provided. Balance training is one such practice currently being used in patients with Functional Ankle Instability [3]. Balance training has been hypothesized to work by activating the mechanoreceptors present in the joint capsule and ligaments of the ankle, which in turn increases the sensory output . These Balance exercises are also found to improve proprioception and thereby improve performance and a sense of stability in individuals with FAI. In addition to these exercises, various external supports are available that help reduce the instability, such as Kinesiotape, brace and much more. Kinesiotape is a cotton strip that is compatible with the skin and is able to stretch up-to 140% its original length. It is a low cost, conveniently accessible tool that can be used to treat various conditions as well as facilitate muscle activity, provide joint stability, postural control and improve physical performance .
Some of the authors have suggested that KT works because of its ability to increase the number of motor units recruited in the muscle. The skin folds due to the increased nature of its elasticity, resulting in increased space below the skin improving circulation and lymphatic drainage. KT has shown improvement in static balance as measured using Balance Error Scoring System . However, there is contradicting and highly inconsistent literature on the effectiveness of KT in improving proprioception, balance Range of Motion in people with Functional ankle instability .
There have been some studies that have focused on the effects of KT and balance exercises on postural control and balance in athletic population . Most of these studies have focused on athletes in organized sports, leaving out the remainder of the population, majority of whom are recreational players. Consequently, there is a need for more research in this population as these are the people who most often do not undergo any type of sports specific training or get any type of rehabilitation post-injury. These are the people who ignore their injuries and its symptoms simply because they do not have the time or sometimes, the money to avail proper rehabilitation due to their hectic work life.
Therefore, this study focuses on the immediate effects of KT combined with balance training on balance and proprioception in the non-athletic, recreational sports population. This following study is also being conducted to see if the combination of KT and Balance training can be used as a stopgap treatment strategy before a session of recreational sport activity.
- Being tested
- Kinesio tape application followed by single session of balance training on various unstable surfaces.
- Keywords
- lateral ankle sprain, functional ankle instability, kinesiotape, balance training, proprioception, balance error scoring system, star excursion balance test, cumberland ankle instability tool, joint position sense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tape application followed by single session of balance training on various unstable surfaces.Procedure or surgery
Participants with functional ankle instability received balance training on various unstable surfaces after kinesio tape application.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group- Balance training combined with kinesio tape | Experimental | Participants with functional ankle instability received balance training on various unstable surfaces after kinesio tape application. Receives: Procedure: Kinesio tape application followed by single session of balance training on various unstable surfaces. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance error scoring system (BESS)- for static balance
Measured: 24 hours from the recruitment
Star excursion balance test (SEBT)- for dynamic balance
Measured: 24 hours from recruitment
Secondary outcomes (1)
Active joint position reproduction test using digital inclinometer- for proprioception
Measured: 24 hours from recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start21 Sep 2023
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. John's Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132840
- Sponsor's protocol ID
- TH-41/2023
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Balance Training Combined With Kinesio-taping on Static Balance, Dynamic Balance and Proprioception in People With Functional Ankle Instability (FAI)- A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT07132840
- Acronym / sponsor ID
- TH-41/2023
- Keywords
- lateral ankle sprain, functional ankle instability, kinesiotape, balance training, proprioception, balance error scoring system, star excursion balance test, cumberland ankle instability tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. John's Research InstituteUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 20 Aug 2025 (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.
Approximately 70% of all people who have had a simple ankle sprain tend to develop continuing instability and pain. Chronic ankle instability is the most common problem that impairs the patients' daily functions. This can lead to balance issues, chances of recurrent sprain and loss of function.
- Therefore, the investigators are conducting this study to assess the immediate effects of balance exercises along with kinesio-taping on static balance, dynamic balance and joint position sense, and to also assess if this combination can be used as stopgap (quick-fix) to improve balance and proprioception before a session of sports activity in people involved in recreational sports.
- During the study, the participants will receive a one-time application of ankle kinesio-taping followed by an hour of balance training exercises on different surfaces such as Dynair, Bosu, Foam pads, and Mini tramp. Joint position sense will be assessed using a digital inclinometer that is already available in the department.
- The participants will be tested using certain physical tests to assess the static balance and dynamic balance using the Balance Error Scoring System tool and Star Excursion Balance Test respectively which they will perform before and 24 hours post training.
Detailed description
Ankle sprains account for approximately 85% of lower extremity injuries. Ankle sprains are often incorrectly considered to be harmless injuries with no lasting consequences, but in fact, reduced physical activity, patient reported disability, increased symptoms and risk of re-injury and recurrent injury are all commonly reported months and sometimes even years after the first sprain. Close to 70% of those who have suffered an ankle sprain develop ankle instability or "giving way" of the ankle during functional activities . There is also evidence suggesting that repetitive ankle sprains are a risk factor for ankle osteoarthritis. The initial injury may result in 2 types of dysfunctions, mechanical instability or functional instability, this influences the outcome by resulting in either i) recovery from the acute sprain or ii) development of chronic instability.
Functional Ankle Instability [FAI], refers to the sensorimotor and neurological deficits that accompany ligamentous injury. Functional Ankle Instability is used to describe the feeling of their ankle giving way, being more painful and being weaker specifically while performing some activity, compared to before the injury. Functional Ankle Instability has been difficult to measure reliably, until recently. Cumberland Ankle Instability Tool is a 9-item 30-point scale developed specifically to measure the severity of Functional Ankle Instability. The CAIT tool has an 83% sensitivity and 75% specificity . In the acute stage, use of the RICE (Rest, Ice, Compression, and Elevation) protocol is recommended to decrease edema, followed by electro modalities such as electrostimulation, ultrasonic therapy, massage, and manual therapy to decrease pain and speed functional recovery .
The essence of evidence-based practice lies in the effectiveness of the treatment that is being provided. Balance training is one such practice currently being used in patients with Functional Ankle Instability [3]. Balance training has been hypothesized to work by activating the mechanoreceptors present in the joint capsule and ligaments of the ankle, which in turn increases the sensory output . These Balance exercises are also found to improve proprioception and thereby improve performance and a sense of stability in individuals with FAI. In addition to these exercises, various external supports are available that help reduce the instability, such as Kinesiotape, brace and much more. Kinesiotape is a cotton strip that is compatible with the skin and is able to stretch up-to 140% its original length. It is a low cost, conveniently accessible tool that can be used to treat various conditions as well as facilitate muscle activity, provide joint stability, postural control and improve physical performance .
Some of the authors have suggested that KT works because of its ability to increase the number of motor units recruited in the muscle. The skin folds due to the increased nature of its elasticity, resulting in increased space below the skin improving circulation and lymphatic drainage. KT has shown improvement in static balance as measured using Balance Error Scoring System . However, there is contradicting and highly inconsistent literature on the effectiveness of KT in improving proprioception, balance Range of Motion in people with Functional ankle instability .
There have been some studies that have focused on the effects of KT and balance exercises on postural control and balance in athletic population . Most of these studies have focused on athletes in organized sports, leaving out the remainder of the population, majority of whom are recreational players. Consequently, there is a need for more research in this population as these are the people who most often do not undergo any type of sports specific training or get any type of rehabilitation post-injury. These are the people who ignore their injuries and its symptoms simply because they do not have the time or sometimes, the money to avail proper rehabilitation due to their hectic work life.
Therefore, this study focuses on the immediate effects of KT combined with balance training on balance and proprioception in the non-athletic, recreational sports population. This following study is also being conducted to see if the combination of KT and Balance training can be used as a stopgap treatment strategy before a session of recreational sport activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group- Balance training combined with kinesio tape | Experimental | Procedure: Kinesio tape application followed by single session of balance training on various unstable surfaces.Participants with functional ankle instability received balance training on various unstable surfaces after kinesio tape application. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults between the age of 18 - 40 years with a history of at least 1 ankle sprain
- Cumberland Ankle Instability Test score of ≤ 27 indicative of Functional Ankle instability
- No episode of an ankle sprain in the past 3 months
- No history of limb fracture in the past 6 months prior to study
- Absence of vestibular disorders or concussion symptoms
Key exclusion criteria (5 listed)
- Health issue that would interfere with participants safety during exercise
- Participants with active malignancy, cellulitis, skin infection, or open wound.
- Presence of common cold.
- After Inclusion in study:
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 |
|---|---|---|
| Kinesio tape application followed by single session of balance training on various unstable surfaces.Participants with functional ankle instability received balance training on various unstable surfaces after kinesio tape application. | Procedure or surgery | Experimental group- Balance training combined with kinesio tape |
Primary outcome
Balance error scoring system (BESS)- for static balance
Time frame: 24 hours from the recruitment
Star excursion balance test (SEBT)- for dynamic balance
Time frame: 24 hours from recruitment
1 secondary outcome
Active joint position reproduction test using digital inclinometer- for proprioception
Time frame: 24 hours from recruitment
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 27 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Kinesio tape application followed by single session of balance training on various unstable surfaces. in people with Chronic Ankle Instability and Functional Ankle Instability, run by St. John's Research Institute at 1 site in India.
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 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 27 Aug 2025. 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 India. 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?
Balance error scoring system (BESS)- for static balance (time frame: 24 hours from the recruitment). The study lists 2 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 27 Aug 2025.