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OpenTrials
Completed

NCT Number: NCT03659474

Different Cryotherapy Techniques for Skin Surface Temperature, Agility and Balance of Active Youth

Different techniques of cryotherapy application present divergent responses. The objective was to establish differences between methods of application of ankle cryotherapy on skin surface temperature (TSP), agility and balance. The sample consisted of 20 healthy and active young men, 10 men and 10 women, with 21.4 (1.9) years. Initially, all performed the Modified Star Excursion Balance Test, Side Hop Test, and TSP collection of the lateral ankle region by digital thermography. After that, the application of the cryotherapy techniques - ice pack (PG), cold water immersion (LAI) and cryotherapy + compression by Game Ready® (CCGR), all for 20 minutes (') was randomized. The tests and TSP were reassessed in the immediate post-10'', 20'' and 30 'post. After three and six days, the other application forms were reassessed. Thus, the participants were randomly assigned to the three forms of cryotherapy.

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Key information

Conditions

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiane Macedo

Londrina, Paraná, 86038-350, Brazil

About this study

The present study is a longitudinal, randomized clinical trial with a composite sample of physically active individuals, 10 male volunteers and 10 female volunteers, with no history of lower limb injuries and pain complaints at the time collection. The collection will started after the signing of the free and informed consent form. The study was approved by the Research Ethics Committee of the State University of Londrina (UEL), Londrina, Paraná (Resolution 466/2012).

The sample size was calculated using the Power and Sample Size software, with a 95% confidence interval, 5% alpha force and 90%, considering the raw data (mean ± SD) of the surface temperature in the study, "The Magnitude of Tissue Cooling During Cryotherapy With Varied Types of Compression ", where it presented 11.02 and 15.51 as mean, 4.34 of standard deviation and p <0.05. sample was composed of 20 individuals per group.

Initially, a pre-intervention evaluation will performed, where the superficial skin temperature of the ankle region will collected from the participants with a professional Flir C2® thermal camera and two functional tests will be performed: Y test and Side Hop Test (SHT) . After the baseline assessment the participants performed will walk at a constant and comfortable pace.

Immediately after walking, subjects will referred to one of three cryotherapy techniques to be tested: Game Ready® cryotherapy (CGR), ice pack cryotherapy (PG) or cold water ankle immersion (IAF).

For the CGR group, maximum dynamic intermittent compression will used, programmed to maintain a temperature at 1 ° C. In the PG group, the ankle joint will surrounded by three plastic bags containing crushed ice. The IAF group will remain with the ankle joint submerged in cold water at approximately 10 ° C, being controlled by the thermal camera. All treatments were performed for 20 minutes.

The same temperature assessment will performed immediately after 10 minutes, 20 minutes, 30 minutes and 60 minutes after cryotherapy, while the functional tests were re-evaluated immediately, 10, 20 and 30 minutes. The participants will attend for data collection on three distinct days, randomizing one of three interventions each day.

For the performance of the functional tests, the order of onset will randomized. The SHT will analyze the agility of the participant, submitting it in unipodal support with the dominant lower limb without shoes, performing 10 distal mid-lateral jumps about thirty centimeters, as fast as possible, being performed three times. The balance will analyzed through the Y test, with the barefoot participant positioned the dominant foot, at the intersection between all diagonals, so that the malleolar line would be in the center of them, and with the other foot the participants pushed a small, light box as far as he can without removing his support foot. Statistical analysis will be performed using SPSS software version 2.2, and the level of significance was set at 5%. It will used and test and Shapiro Wilk to test the normality of the data. From this, the ANOVA test will be used to compare study groups and moments studied.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • physically active
  • no history of lower limb injuries
  • no complaints of pain at the time of collection

Exclusion criteria

  • sedentary
  • injury or ankle surgery

Treatment and study plan

compression

Other

compression by Game Ready

ice pack

Other

cryotherapy for ice pack

immersion

Other

immersion therapy

Primary outcomes

  1. Change in skin surface temperature after intervention

    Time frame: pre-intervention, Immediately after, post 10, 20 and 30 minutes

    evaluated by professional thermal camera Flir C2®

Secondary outcomes

  1. Change in agility after intervention

    Time frame: pre-intervention, Immediately after, post 10, 20 and 30 minutes

    evaluated by Side Hop Test

  2. Change in postural control after intervention

    Time frame: pre-intervention, Immediately after, post 10, 20 and 30 minutes

    evaluated by Y test

Sponsors and collaborators

Lead sponsor

Universidade Estadual de Londrina

Other

Registry information

Official study title

Different Cryotherapy Techniques for Skin Surface Temperature, Agility and Balance of Active Youth: Analysis Between Ice Pack, Cryoimmersion and Game Ready®

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2018
Registry last updated
Sep 6, 2018

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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