Ankle InstabilityNCT05709808
Kinesio-Taping and Ankle Instability in Recreational Runners
A study testing Kinesio-taping, exercises and mixed kinesiotape plus exercises in people with Ankle Instability, run by University of Hail at 1 site in Saudi Arabia.
Trial summary
this clinical trial intended to investigate the effect of applying kinesiotaping to an ankle with mild instability in the recreational runners. the authors hypothesize that kinesiotaping might improve postural stability in those patients and facilitate returning to activity Read more about this study
- Who is it for?
- Ages 17 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Instability
- What is being tested?
- Kinesio-taping, exercises and mixed kinesiotape plus exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Apr 2021to 30 Sep 2021
- 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 17 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy college-age males;
- participate regularly in running activity (1-3 times /week for the last 6 months);
- Mild ankle instability (score within 24.5-27) according to Cumberland Ankle Instability Tool (CAIT)
Who cannot join
- vestibular system problems; and presence of traumatic brain injury in the last three months;
- fracture or surgery to lower limb;
- drugs that affect the balance or vestibular system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Kinesio-Taping on Mild Ankle Instability in Recreational Runners
this clinical trial intended to investigate the effect of applying kinesiotaping to an ankle with mild instability in the recreational runners.
the authors hypothesize that kinesiotaping might improve postural stability in those patients and facilitate returning to activity
Read the detailed description
Running as a recreational sport has been considered a very popular sport that has been practiced by people of both genders and in different age groups. This sport does not need a special place or equipment for practice, this advantage further increased its popularity, as well as, it has a great effect on physical and mental health and decreases the mortality rate by 25-40%. Running is contributing to lowering body fats, reduction of weight, increase of lean body mass, improving resting heart rate, enhancing cardiovascular fitness, and helping in the cessation of smoking.
The incidence of people who practice running as an activity is high in European civilization as it reaches up to 12.5-31% of the population. Recreational runners might be at high risk for running-related injuries as reported 6.3 injuries per 1000 training hours in comparison to 3.4 injuries in the other types of sports activities.
It is worth mentioning that, the prevalence of studies for running-related injuries increases with time. Studies have identified the incidence of injuries extends from 25%-85% in running activities. The ankle joint occupies the second place, after the knee joint, as the most vulnerable joint to injury during running. These numbers indicate the importance of injury prevention and emphasize the methods that help in the reduction of recurrence as it was recorded the average time for recovery is 72 days which means a long period of caseation of all activities and a burden on the economy.
While most of the running-related injuries are either gradually onset or due to overuse, sudden ankle injuries might also occur. One of the most common ankle injuries is the lateral sprains of the sub-talar joint. This injury may lead to trauma to the soft tissues and bony components and consequently affect the function of the injured joint.
Ankle sprain causes a decrease in postural stability and neuromuscular control due to improper somatosensory functioning which is linked to this injury on both sides of the lower limbs either on the affected or non-affected one. postural stability is one of the major functions that depend mainly on the cues originating from proprioceptors. Cutaneous stimulation, especially skin stretching, has been considered as an influential factor in joint proprioception. More accurate joint position sense was reported when the skin was stimulated.
Consequently, any therapeutic intervention which can stimulate skin receptors might have positive effects on the related joint proprioception and may enhance the sensorimotor functioning so it might help lower the risk for ankle injuries.
Kinesio tape (KT) is the application of an adhesive and elastic cotton tape on the skin. This tape is anti-allergic and can be left in place for 3 to 5 days without adverse effects. This therapeutic method has gained increasing interest in the field of rehabilitation and sport. It provides a stretching effect on the skin and may stimulate the cutaneous aspect of the proprioception which in turn may affect the somatosensory function.
A study was conducted with KT on medial tibial stress syndrome which showed a reduction of the loading stress in these patients. This syndrome is usually resulted from repeated microtrauma to the tissues and usually reported in physically active persons as recreation runners. Various studies reported significant improvement in postural control, dynamic, static balance, and improving strength after applying the taping on the participants with ankle instability. Even though, a recently published systematic review reported there is limited scientific evidence regarding the use of KT in the rehabilitation of musculoskeletal injuries.
Exercise is still the best intervention for the treatment of patients with ankle instability as it is designed to stimulate proprioception and decrease the risk of ankle injuries. However, specially designed programs and their preventive effect are still inconclusive and need further research. In addition, there is still controversy in using the KT in the rehabilitation of ankle instability as there was a study that reported no significant improvements in the balance measurements.
Most of the studies are conducted on healthy subjects or athletes but no one takes care of non-athletes who are practicing regular activities as recreational runners, as well as, one of the main components of the prevention of injuries and their recurrence is the building up of awareness especially the increase of the popularity of the taping through different media and the increase of using it during competitive matches. So the purpose of this study is to compare the KT versus special proprioceptive training on the postural stability in recreational runners.
- Conditions
- Ankle Instability
- Being tested
- Kinesio-taping, exercises, mixed kinesiotape plus exercises
- Keywords
- ankle instability, recreational runners, postural stability, Kinesio-Taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio-tapingOther
kinesiotape is a method of taping used to improve support and increase proprioceptive awareness of the joint, while the exercise program was designed to improve postural stability and balance
exercisesOther
A standard proprioceptive training program will be implemented three times a week. The training includes both static and dynamic balance on Wobble board with the eyes open while the last stage will be repeated with the eyes closed.
mixed kinesiotape plus exercisesOther
kinesiotape is a method of taping used to improve support and increase proprioceptive awareness of the joint, while the exercise program was designed to improve postural stability and balance. A standard proprioceptive training program will be implemented three times a week. The training includes both static and dynamic balance on Wobble board with the eyes open while the last stage will be repeated with the eyes closed.
| Study group | Role | What they receive |
|---|---|---|
| Mixed group | Experimental | This taping technique is designed to guard against lateral ankle sprains. Kinesio-tape will be applied to the unstable ankle for a lateral ankle sprain. 4 strips of the tape with different stretching percentages will be applied while the ankle joint in a relaxed position.
ankle exercises will be conducted for 8 weeks, 3 times/ week, each session will last for 60 minutes.
A standard proprioceptive training program will be implemented three times a week. The training includes both static and dynamic balance on Wobble board with the eyes open while the last stage will be repeated with the eyes closed. Receives: Other: Kinesio-taping; Other: exercises; Other: mixed kinesiotape plus exercises |
| Exercise group | Active comparator | received exercises and proprioceptive training similar as described in the experimental group Receives: Other: exercises |
| Kinesio-tape group | Experimental | will receive Kinesio-tape only as described in the mixed group This taping technique is designed to guard against lateral ankle sprains. Kinesio-tape will be applied to the unstable ankle for a lateral ankle sprain. 4 strips of tape with different stretching percentages will be applied while the ankle joint in a relaxed position. Receives: Other: Kinesio-taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
postural stability
measured by the score gained on the appropriate test on biodex balance system. this test has different difficult levels from 1 - 6 with the highest numbet indicated the easiest level. the Biodex device records the number of errors the patient achieve so the higher the patient record the lower the stability score
Measured: 4 weeks
Secondary outcomes (1)
star excursion test
The test initially encourages the maximal reaching of the opposite leg in eight directions while maintaining loading on a single leg. A tape was used to be stuck on the floor and a protractor to divide the tape into 8 directions with 45° in-between. During the examination the participants shod not touch the floor and maintaining their balance, the test repeated three times and the average was calculated. the hgher the reach distance the better the balance status of the participants
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 posted2 Feb 2023
- Study start30 Apr 2021
- Primary completion30 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trials contain 2 groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Mohamed Hussein, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709808
- Sponsor's protocol ID
- 12911
- Status last verified
- Mar 2023
- First submitted
- 10 Dec 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all data will be kept in a safe to keep confidentiality of the patient data
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesio-Taping on Mild Ankle Instability in Recreational Runners
- ClinicalTrials.gov ID
- NCT05709808
- Acronym / sponsor ID
- 12911
- Conditions
- Ankle Instability
- Keywords
- ankle instability, recreational runners, postural stability, Kinesio-Taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of HailUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 2 Feb 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.
this clinical trial intended to investigate the effect of applying kinesiotaping to an ankle with mild instability in the recreational runners.
the authors hypothesize that kinesiotaping might improve postural stability in those patients and facilitate returning to activity
Detailed description
Running as a recreational sport has been considered a very popular sport that has been practiced by people of both genders and in different age groups. This sport does not need a special place or equipment for practice, this advantage further increased its popularity, as well as, it has a great effect on physical and mental health and decreases the mortality rate by 25-40%. Running is contributing to lowering body fats, reduction of weight, increase of lean body mass, improving resting heart rate, enhancing cardiovascular fitness, and helping in the cessation of smoking.
The incidence of people who practice running as an activity is high in European civilization as it reaches up to 12.5-31% of the population. Recreational runners might be at high risk for running-related injuries as reported 6.3 injuries per 1000 training hours in comparison to 3.4 injuries in the other types of sports activities.
It is worth mentioning that, the prevalence of studies for running-related injuries increases with time. Studies have identified the incidence of injuries extends from 25%-85% in running activities. The ankle joint occupies the second place, after the knee joint, as the most vulnerable joint to injury during running. These numbers indicate the importance of injury prevention and emphasize the methods that help in the reduction of recurrence as it was recorded the average time for recovery is 72 days which means a long period of caseation of all activities and a burden on the economy.
While most of the running-related injuries are either gradually onset or due to overuse, sudden ankle injuries might also occur. One of the most common ankle injuries is the lateral sprains of the sub-talar joint. This injury may lead to trauma to the soft tissues and bony components and consequently affect the function of the injured joint.
Ankle sprain causes a decrease in postural stability and neuromuscular control due to improper somatosensory functioning which is linked to this injury on both sides of the lower limbs either on the affected or non-affected one. postural stability is one of the major functions that depend mainly on the cues originating from proprioceptors. Cutaneous stimulation, especially skin stretching, has been considered as an influential factor in joint proprioception. More accurate joint position sense was reported when the skin was stimulated.
Consequently, any therapeutic intervention which can stimulate skin receptors might have positive effects on the related joint proprioception and may enhance the sensorimotor functioning so it might help lower the risk for ankle injuries.
Kinesio tape (KT) is the application of an adhesive and elastic cotton tape on the skin. This tape is anti-allergic and can be left in place for 3 to 5 days without adverse effects. This therapeutic method has gained increasing interest in the field of rehabilitation and sport. It provides a stretching effect on the skin and may stimulate the cutaneous aspect of the proprioception which in turn may affect the somatosensory function.
A study was conducted with KT on medial tibial stress syndrome which showed a reduction of the loading stress in these patients. This syndrome is usually resulted from repeated microtrauma to the tissues and usually reported in physically active persons as recreation runners. Various studies reported significant improvement in postural control, dynamic, static balance, and improving strength after applying the taping on the participants with ankle instability. Even though, a recently published systematic review reported there is limited scientific evidence regarding the use of KT in the rehabilitation of musculoskeletal injuries.
Exercise is still the best intervention for the treatment of patients with ankle instability as it is designed to stimulate proprioception and decrease the risk of ankle injuries. However, specially designed programs and their preventive effect are still inconclusive and need further research. In addition, there is still controversy in using the KT in the rehabilitation of ankle instability as there was a study that reported no significant improvements in the balance measurements.
Most of the studies are conducted on healthy subjects or athletes but no one takes care of non-athletes who are practicing regular activities as recreational runners, as well as, one of the main components of the prevention of injuries and their recurrence is the building up of awareness especially the increase of the popularity of the taping through different media and the increase of using it during competitive matches. So the purpose of this study is to compare the KT versus special proprioceptive training on the postural stability in recreational runners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled trials contain 2 groups
| Arm | Type | Receives |
|---|---|---|
| Mixed group | Experimental | Other: Kinesio-taping, Other: exercises, Other: mixed kinesiotape plus exercisesThis taping technique is designed to guard against lateral ankle sprains. Kinesio-tape will be applied to the unstable ankle for a lateral ankle sprain. 4 strips of the tape with different stretching percentages will be applied while the ankle joint in a relaxed position. ankle exercises will be conducted for 8 weeks, 3 times/ week, each session will last for 60 minutes. A standard proprioceptive training program will be implemented three times a week. The training includes both static and dynamic balance on Wobble board with the eyes open while the last stage will be repeated with the eyes closed. |
| Exercise group | Active comparator | Other: exercisesreceived exercises and proprioceptive training similar as described in the experimental group |
| Kinesio-tape group | Experimental | Other: Kinesio-tapingwill receive Kinesio-tape only as described in the mixed group This taping technique is designed to guard against lateral ankle sprains. Kinesio-tape will be applied to the unstable ankle for a lateral ankle sprain. 4 strips of tape with different stretching percentages will be applied while the ankle joint in a relaxed position. |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- healthy college-age males;
- participate regularly in running activity (1-3 times /week for the last 6 months);
- Mild ankle instability (score within 24.5-27) according to Cumberland Ankle Instability Tool (CAIT)
Key exclusion criteria (3 listed)
- vestibular system problems; and presence of traumatic brain injury in the last three months;
- fracture or surgery to lower limb;
- drugs that affect the balance or vestibular system.
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-tapingkinesiotape is a method of taping used to improve support and increase proprioceptive awareness of the joint, while the exercise program was designed to improve postural stability and balance | Other | Kinesio-tape group, Mixed group |
| exercisesA standard proprioceptive training program will be implemented three times a week. The training includes both static and dynamic balance on Wobble board with the eyes open while the last stage will be repeated with the eyes closed. | Other | Exercise group, Mixed group |
| mixed kinesiotape plus exerciseskinesiotape is a method of taping used to improve support and increase proprioceptive awareness of the joint, while the exercise program was designed to improve postural stability and balance. A standard proprioceptive training program will be implemented three times a week. The training includes both static and dynamic balance on Wobble board with the eyes open while the last stage will be repeated with the eyes closed. | Other | Mixed group |
Primary outcome
postural stability
Time frame: 4 weeks
measured by the score gained on the appropriate test on biodex balance system. this test has different difficult levels from 1 - 6 with the highest numbet indicated the easiest level. the Biodex device records the number of errors the patient achieve so the higher the patient record the lower the stability score
1 secondary outcome
star excursion test
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 22 Mar 2023.
- Individual participant dataSharing planned: No. all data will be kept in a safe to keep confidentiality of the patient data
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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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-taping, exercises and mixed kinesiotape plus exercises in people with Ankle Instability, run by University of Hail at 1 site in Saudi Arabia.
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 3 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 22 Mar 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 Saudi Arabia. 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 stability (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 22 Mar 2023.