NCT04257916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

February 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2020

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

February 2, 2020

Last Update Submit

September 1, 2021

Conditions

Keywords

KinesiotapeMyofascialAnkle sprainPainStability

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

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.

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.

Other: Manual therapy group

Interventions

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.

Also known as: kinesio group
Experimental group

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.

Control group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male soccer players
  • to 35 years old
  • History of ankle sprain recurrences

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European University of Madrid

Madrid, Spain

Location

MeSH Terms

Conditions

Ankle InjuriesPain

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2020

First Posted

February 6, 2020

Study Start

February 10, 2020

Primary Completion

April 30, 2020

Study Completion

May 10, 2020

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations