- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03659474
Different Cryotherapy Techniques for Skin Surface Temperature, Agility and Balance of Active Youth
Different Cryotherapy Techniques for Skin Surface Temperature, Agility and Balance of Active Youth: Analysis Between Ice Pack, Cryoimmersion and Game Ready®
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Paraná
-
Londrina, Paraná, Brazil, 86038-350
- Christiane Macedo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Cryotherapy Techniques
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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