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NCT Number: NCT04257916

Manual Therapy, Kinesiotape and Strength Training 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.

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Key information

Conditions

Ankle Sprains Ankle Injuries Leg Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

European University of Madrid

Madrid, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental

Other

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: kinesio group

Manual therapy group

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Investigación en Hemofilia y Fisioterapia

Network

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2020
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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