Ankle SprainsNCT04257916
Manual Therapy, Kinesiotape and Strength Training in Soccer Players With Recurrent Ankle Sprains
A study testing Experimental and Manual therapy group in people with Ankle Sprains, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction. The ankle sprain is one of the most prevalent injuries in soccer players. The muscle strength deficit is one of the variables that can most influence the development of a sprain. It has been indicated how the Kinesiotape and the myofascial direct induction technique can improve functionality. Aim. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Experimental and Manual therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2020to 10 May 2020
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male soccer players
- 18 to 35 years old
- History of ankle sprain recurrences
Who cannot join
- Players who suffered a sprain in the previous month
- Footballers who were taking anti-inflammatory drugs
- Players undergoing another type of physiotherapy treatment at the time of the study
- Soccer players who do not sign the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Manual Therapy, Kinesiotape and Strength Training in Improving the Range of Ankle Movement, Stability, Strength and Pain in Soccer Players With Recurrent Ankle Sprains
Introduction. The ankle sprain is one of the most prevalent injuries in soccer players. The muscle strength deficit is one of the variables that can most influence the development of a sprain. It has been indicated how the Kinesiotape and the myofascial direct induction technique can improve functionality.
Aim. To verify the effectiveness of the KinesioTape and the myofascial technique combined with strength training, in the reduction of pain, Rom increase, stability and strength in subjects who suffered ankle sprains.
Read more
Study design. Randomized, multicentric clinical study with follow-up. Methods. A random assignment of the subjects recruited in two study groups will be carried out: experimental and control group. The treatment will last 4 weeks, with 2 weekly sessions, of 50-60 minutes. The intervention includes the application of kinesiotape and myofascial treatment with strength training. The study variables will be pain (VAS), mobility (goniometer), stability (ProKin balance) and strength (MicroFet). A descriptive statistical analysis will be carried out calculating the main statistical characteristics. By means of the Kolmogorov-Smirnov test the distribution of the normality of the sample will be assessed. With the t-student test for related samples we will calculate the difference of means between the evaluations made in both groups. With an ANOVA of repeated measures we will calculate the intra and intersubject effect. The calculation of the effect size will be done with the Cohen formula.
Expected results. Improvement in stability, increase in range of motion, decrease in pain and increase in strength.
- Conditions
- Ankle Sprains
- Being tested
- Experimental, Manual therapy group
- Keywords
- Kinesiotape, Myofascial, Ankle sprain, Pain, Stability
- Medical subject headings
- Ankle Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called kinesio group
Myofascial technique intervention of the subastragalar joint, kinesiotape and eccentric training with isoinercial machine. The intervention lasted 4 weeks. Each treatment session lasted 50 minutes, with 2 sessions a week. Between training sessions, the indicated break was 48 hours.
Manual therapy groupOther
Myofascial technique of the subastragalar joint and eccentric training with isoinercial machine. The intervention lasted 4 weeks. Each treatment session lasted 50 minutes, with 2 sessions a week. Between training sessions, the indicated break was 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The intervention by kinesiotape will be done with the player in supine position with the foot in dorsal flexion, anchoring the strip below the sole of the foot without tension, adding 50-70% tension until internal and external malleolus, and ending without tension. Another strip will be placed under the external malleolus, anchoring the bandage and following the talus (50-70% tension), leaving the scaphoid bulge free, surrounding the plant without tension and leaving the 5th metatarsal free. The bandage continues on the peroneal-astragalin ligament and the external malleolus (50-70% tension), until the tendon without tension. In the end we will surround the internal malleolus to the Achilles tendon without tension, ending with the same tension in the external malleolus and the neck of the talus.
The myofascial technique and strength training will be the same in both groups. Receives: Other: Experimental |
| Control group | Active comparator | The myofascial technique will be carried out by positioning the caudal hand of the physiotherapist in the astragalin and heel region, and the cranial hand in the middle foot. With a tibiotarsal traction, the foot will be everted, performing a shear in the astragalin zone, using a combined and slow technique.
All players will warm up for 10 minutes on tape, at a speed of 7 km / h without inclination. The strength work was carried out with an isoinertial machine (Space Whell) with intervalic methodology: 20 "-10", with 4 series and doing three exercises: Squat, Lunges and Deadlift. One minute breaks will be made between sets. Receives: Other: Manual therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline ankle range of motion after treatment and at 1 month
It will be done with a digital goniometer (Get my Rom model - Iphone 5 - Interactive Medical Productions). The movements of dorsal and plantar flexion, inversion and eversion will be measured. In measuring dorsal and plantar flexion, the goniometer will be placed on the 5th metatarsal. In measuring the inversion and eversion, the goniometer will be placed in the plantar part in line with the metatarsals. The unit of measure is the degree.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (3)
Change from baseline isometric ankle strength after treatment and at 1 month
A digital dynamometer (MicroFet®2 model - Hoggan Health Industries) will be used. To measure dorsal flexion, the instrument will be placed in the dorsal part of the foot in the region of the metatarsals, and for plantar flexion in the plantar part at the level of the metatarsals. In the eversion and abduction movements, the instrument will be placed in the lateral portion of the 5th metatarsal, while for inversion and adduction in the medial portion of the 1st metatarsal. Each movement will be repeated three times, one minute break.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline stability after treatment and at 1 month
It will be done with the PWalk instrument. The software will allow measurement for 30 seconds with eyes open and closed. This measuring instrument will allow to evaluate: the movement with respect to the center of pressure in the frontal plane and sagittal plane (measured in mm). The evaluation will be done in charge.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline ankle joint pain perception after treatment and at 1 month
Pain assessment will be assessed through the visual analogue scale (VAS). Anteroposterior and mediolateral movements will be performed. This scale is used using a scale of 0 to 10 points, where 0 indicates no pain and unstable, 10 indicates the maximum pain perceived.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start10 Feb 2020
- Primary completion30 Apr 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257916
- Sponsor's protocol ID
- KTISO
- Status last verified
- Sep 2021
- First submitted
- 2 Feb 2020
- Last updated
- 2 Sep 2021
- 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 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Therapy, Kinesiotape and Strength Training in Improving the Range of Ankle Movement, Stability, Strength and Pain in Soccer Players With Recurrent Ankle Sprains
- ClinicalTrials.gov ID
- NCT04257916
- Acronym / sponsor ID
- KTISO
- Conditions
- Ankle Sprains
- Keywords
- Kinesiotape, Myofascial, Ankle sprain, Pain, Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 6 Feb 2020 (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.
Introduction. The ankle sprain is one of the most prevalent injuries in soccer players. The muscle strength deficit is one of the variables that can most influence the development of a sprain. It has been indicated how the Kinesiotape and the myofascial direct induction technique can improve functionality.
Aim. To verify the effectiveness of the KinesioTape and the myofascial technique combined with strength training, in the reduction of pain, Rom increase, stability and strength in subjects who suffered ankle sprains.
Study design. Randomized, multicentric clinical study with follow-up. Methods. A random assignment of the subjects recruited in two study groups will be carried out: experimental and control group. The treatment will last 4 weeks, with 2 weekly sessions, of 50-60 minutes. The intervention includes the application of kinesiotape and myofascial treatment with strength training. The study variables will be pain (VAS), mobility (goniometer), stability (ProKin balance) and strength (MicroFet). A descriptive statistical analysis will be carried out calculating the main statistical characteristics. By means of the Kolmogorov-Smirnov test the distribution of the normality of the sample will be assessed. With the t-student test for related samples we will calculate the difference of means between the evaluations made in both groups. With an ANOVA of repeated measures we will calculate the intra and intersubject effect. The calculation of the effect size will be done with the Cohen formula.
Expected results. Improvement in stability, increase in range of motion, decrease in pain and increase in strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: ExperimentalThe intervention by kinesiotape will be done with the player in supine position with the foot in dorsal flexion, anchoring the strip below the sole of the foot without tension, adding 50-70% tension until internal and external malleolus, and ending without tension. Another strip will be placed under the external malleolus, anchoring the bandage and following the talus (50-70% tension), leaving the scaphoid bulge free, surrounding the plant without tension and leaving the 5th metatarsal free. The bandage continues on the peroneal-astragalin ligament and the external malleolus (50-70% tension), until the tendon without tension. In the end we will surround the internal malleolus to the Achilles tendon without tension, ending with the same tension in the external malleolus and the neck of the talus. The myofascial technique and strength training will be the same in both groups. |
| Control group | Active comparator | Other: Manual therapy groupThe myofascial technique will be carried out by positioning the caudal hand of the physiotherapist in the astragalin and heel region, and the cranial hand in the middle foot. With a tibiotarsal traction, the foot will be everted, performing a shear in the astragalin zone, using a combined and slow technique. All players will warm up for 10 minutes on tape, at a speed of 7 km / h without inclination. The strength work was carried out with an isoinertial machine (Space Whell) with intervalic methodology: 20 "-10", with 4 series and doing three exercises: Squat, Lunges and Deadlift. One minute breaks will be made between sets. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male soccer players
- 18 to 35 years old
- History of ankle sprain recurrences
Key exclusion criteria (4 listed)
- Players who suffered a sprain in the previous month
- Footballers who were taking anti-inflammatory drugs
- Players undergoing another type of physiotherapy treatment at the time of the study
- Soccer players who do not sign the informed consent document.
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 |
|---|---|---|
| ExperimentalAlso: kinesio groupMyofascial technique intervention of the subastragalar joint, kinesiotape and eccentric training with isoinercial machine. The intervention lasted 4 weeks. Each treatment session lasted 50 minutes, with 2 sessions a week. Between training sessions, the indicated break was 48 hours. | Other | Experimental group |
| Manual therapy groupMyofascial technique of the subastragalar joint and eccentric training with isoinercial machine. The intervention lasted 4 weeks. Each treatment session lasted 50 minutes, with 2 sessions a week. Between training sessions, the indicated break was 48 hours. | Other | Control group |
Primary outcome
Change from baseline ankle range of motion after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
It will be done with a digital goniometer (Get my Rom model - Iphone 5 - Interactive Medical Productions). The movements of dorsal and plantar flexion, inversion and eversion will be measured. In measuring dorsal and plantar flexion, the goniometer will be placed on the 5th metatarsal. In measuring the inversion and eversion, the goniometer will be placed in the plantar part in line with the metatarsals. The unit of measure is the degree.
3 secondary outcomes
Change from baseline isometric ankle strength after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline stability after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline ankle joint pain perception after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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 2 Sep 2021.
Related trials for Ankle Sprains
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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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental and Manual therapy group in people with Ankle Sprains, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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 4 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 2 Sep 2021. 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 Spain. 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?
Change from baseline ankle range of motion after treatment and at 1 month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 2 Sep 2021.