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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05331092
Other study ID # EC003
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 30, 2022
Est. completion date July 1, 2022

Study information

Verified date April 2022
Source São Paulo State University
Contact Flavia A Carvalho, MSc
Phone +5518997443624
Email fla.acarvalho@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The ankle joint is commonly used and also stricken by high loads and injuries in sports. One technique in emphasis is cryotherapy, a physiotherapeutical intervention characterized by the use of low temperatures for tissue trauma's rehabilitation. Several studies analysed the effects of cryotherapy and brought important results related to pain and strength reduction, also to muscle contraction speed reduction. Although, considering the risk-benefit from de intervention it's pertinent to observe the presence of deleterious effects, especially the ones that impact on motor function. This scenario has been brought by scientists and currently the main gap from this theme resides on the repercussions of the technique application on functional answers


Description:

Eighty participants will receive control (rest) and the experimental condition (cryotherapy), with an interval of 48 hours. The intervention group will undergo: i) assessment, ii) 20 minutes of cryotherapy, iii) reassessment, iv) 20 minutes of rest and v) reassessment, while the control group remains at rest for 20 minutes. Assessments will be composed of ankle function by the modified star excursion balance test, muscle tone by the myoton pro, skin temperature by a thermographic camera, thermic comfort, perception of balance and beliefs in cryotherapy. Data will be described using mean and standard deviation and compared by Mixed ANOVA (time x intervention) with post Bonferroni tests, with significance level of 0.05.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date July 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 28 Years
Eligibility Inclusion Criteria: - 18 to 28 years old - healthy - no musculoskeletal complaints Exclusion Criteria: - failure to follow protocol - complaints of injury or pain during the assessments

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cryotherapy
20 minutes of cryotherapy on the dominant ankle with ice bags

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
São Paulo State University

Outcome

Type Measure Description Time frame Safety issue
Primary Ankle balance The Modified Star Excursion Balance Test will measure lower limb reach distance in centimeters Change from baseline to 20 minutes
Primary Ankle balance The Modified Star Excursion Balance Test will measure lower limb reach distance in centimeters Change from baseline to 40 minutes
Secondary Skin Temperature thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) Change from baseline to 20 minutes
Secondary Skin Temperature thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) Change from baseline to 25 minutes
Secondary Skin Temperature thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) Change from baseline to 30 minutes
Secondary Skin Temperature thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) Change from baseline to 35 minutes
Secondary Skin Temperature thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) Change from baseline to 40 minutes
Secondary Thermic Comfort a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used Change from baseline to 20 minutes
Secondary Thermic Comfort a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used Change from baseline to 40 minutes
Secondary Balance Perception a likert scale will be used to answer the question " How good was your balance over the test?" 1=nothing, 2=a little, 3=moderate, 4= a lot, 5=extremely Change from baseline to 20 minutes
Secondary Balance Perception a likert scale will be used to answer the question " How good was your balance over the test?" 1=nothing, 2=a little, 3=moderate, 4= a lot, 5=extremely Change from baseline to 40 minutes
Secondary muscle tone Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the tibialis anterior and soleus Change from baseline to 20 minutes
Secondary muscle tone Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the tibialis anterior and soleus Change from baseline to 25 minutes
Secondary muscle tone Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the tibialis anterior and soleus Change from baseline to 30 minutes
Secondary muscle tone Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the tibialis anterior and soleus Change from baseline to 35 minutes
Secondary muscle tone Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the tibialis anterior and soleus Change from baseline to 40 minutes
Secondary Beliefs The participants will respond yes or no to the questions "Do you believe that cryotherapy is an effect treatment for acute injuries?" and "Do you believe cryotherapy have deleterious effects on muscle function?" baseline
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