- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04257916
Manual Therapy, Kinesiotape and Strength Training in Soccer Players With Recurrent Ankle Sprains
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain
- European University of Madrid
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male soccer players
- 18 to 35 years old
- History of ankle sprain recurrences
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
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. |
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.
Other Names:
|
Active Comparator: Control group
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Screening visit, within the first seven days after treatment and after one month follow-up visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Screening visit, within the first seven days after treatment and after one month follow-up visit
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KTISO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankle Sprains
-
Riphah International UniversityRecruiting
-
Riphah International UniversityRecruitingAnkle SprainsPakistan
-
MEDRx USA, Inc.CompletedAnkle SprainsUnited States
-
Centre Hospitalier Universitaire de Saint EtienneRecruiting
-
Taipei Medical University WanFang HospitalUnknown
-
Lazaros LazarouCompletedAnkle SprainsGreece
-
Universiteit AntwerpenUniversity Hospital, Antwerp; University of Ulster; Bern University of Applied...Recruiting
-
Christian OlsenUniversity of Copenhagen; University Hospital Bispebjerg and Frederiksberg; Regionshospitalet... and other collaboratorsUnknown
-
Logan University, Inc.Sport and Spine Rehab Clinical Research Foundation; Parker University; Brentwood...Terminated
-
Sylvia Maher Mohsen Farid HannaNot yet recruiting
Clinical Trials on Experimental
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHPV | Related Malignancy | Related CarcinomaUnited States
-
Polish Mother Memorial Hospital Research InstituteCompletedBottle Feeding | PrematurePoland
-
Wake Forest University Health SciencesMichael J. Fox Foundation for Parkinson's ResearchWithdrawn
-
Piedmont HealthcareLivaNovaCompletedHeart FailureUnited States
-
Finis Terrae UniversityNot yet recruitingPostoperative Pain | Respiratory ComplicationChile
-
University of Illinois at ChicagoRecruiting
-
Le Mans UniversiteActive, not recruiting
-
Aston UniversityBirmingham Women's and Children's NHS Foundation TrustRecruitingReflex Epilepsy, Photosensitive | EyeglassesUnited Kingdom
-
Cardenal Herrera UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisMedtronic - MITG; Kimberly-Clark CorporationCompletedMechanical Ventilation Complication | Acute Respiratory FailureFrance