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

September 4, 2018 updated by: Universidade Estadual de Londrina

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Paraná
      • Londrina, Paraná, Brazil, 86038-350
        • Christiane Macedo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: cryotherapy by compression
maximum dynamic intermittent compression, programmed to maintain a temperature at 1 ° C
compression by Game Ready
EXPERIMENTAL: ice pack
the ankle joint was surrounded by three plastic bags containing crushed ice.
cryotherapy for ice pack
EXPERIMENTAL: cold water immersion
articulation of the ankle submerged in cold water at approximately 10 ° C, being controlled by the thermal camera.
immersion therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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®
pre-intervention, Immediately after, post 10, 20 and 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in agility after intervention
Time Frame: pre-intervention, Immediately after, post 10, 20 and 30 minutes
evaluated by Side Hop Test
pre-intervention, Immediately after, post 10, 20 and 30 minutes
Change in postural control after intervention
Time Frame: pre-intervention, Immediately after, post 10, 20 and 30 minutes
evaluated by Y test
pre-intervention, Immediately after, post 10, 20 and 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

July 12, 2018

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (ACTUAL)

September 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Cryotherapy Techniques

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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