Ignite Creation Date:
2024-05-06 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03659474
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2018-02-16
Brief Title:
Different Cryotherapy Techniques for Skin Surface Temperature Agility and Balance of Active Youth
Sponsor:
Universidade Estadual de Londrina
Organization:
Universidade Estadual de Londrina
Study Overview
Official Title:
Different Cryotherapy Techniques for Skin Surface Temperature Agility and Balance of Active Youth Analysis Between Ice Pack Cryoimmersion and Game Ready
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 214 19 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
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 4662012
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 1102 and 1551 as mean 434 of standard deviation and p 005 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 22 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
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 1102 and 1551 as mean 434 of standard deviation and p 005 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 22 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None