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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

India1 site
  • St. John's Medical college & Hospital

    Bangalore, Karnataka, 560034

Other trials in India

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 groups in NCT07132840
Study groupRoleWhat they receive
Experimental group- Balance training combined with kinesio tapeExperimentalParticipants 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.

  1. Balance error scoring system (BESS)- for static balance

    Measured: 24 hours from the recruitment

  2. Star excursion balance test (SEBT)- for dynamic balance

    Measured: 24 hours from recruitment

Secondary outcomes (1)
  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.

  1. First posted20 Aug 2025
  2. Study start21 Sep 2023
  3. Primary completion25 Jan 2024
  4. Study completion25 Jan 2024

Resources

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)
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

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.

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