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Manual Therapy, Kinesiotape and Strength Training in Soccer Players With Recurrent Ankle Sprains

Primary Purpose

Ankle Sprains

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental
Manual therapy group
Sponsored by
Investigación en Hemofilia y Fisioterapia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains focused on measuring Kinesiotape, Myofascial, Ankle sprain, Pain, Stability

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • European University of Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 2, 2020
Last Updated
September 1, 2021
Sponsor
Investigación en Hemofilia y Fisioterapia
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1. Study Identification

Unique Protocol Identification Number
NCT04257916
Brief Title
Manual Therapy, Kinesiotape and Strength Training in Soccer Players With Recurrent Ankle Sprains
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Investigación en Hemofilia y Fisioterapia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains
Keywords
Kinesiotape, Myofascial, Ankle sprain, Pain, Stability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental
Other Intervention Name(s)
kinesio group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual therapy group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline ankle range of motion after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary Outcome Measure Information:
Title
Change from baseline isometric ankle strength after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline stability after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline ankle joint pain perception after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubén Cuesta-Barriuso, PhD
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
European University of Madrid
City
Madrid
Country
Spain

12. IPD Sharing Statement

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Manual Therapy, Kinesiotape and Strength Training in Soccer Players With Recurrent Ankle Sprains

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