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

Ankle Sprains Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04257916
• Other study ID #: KTISO
• Status: Completed
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: May 10, 2020

Study information

• Verified date: September 2021
• Source: Investigación en Hemofilia y Fisioterapia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 10, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Sprains and Strains

Intervention

Other:
• Experimental
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 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.

Locations

Country	Name	City	State
Spain	European University of Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Investigación en Hemofilia y Fisioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary	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.	Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary	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.	Screening visit, within the first seven days after treatment and after one month follow-up visit