Effects of Cryotherapy on Ankle Function

Functional Status Clinical Trial

Official title:

Effects of Cryotherapy on Ankle Function: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05331092
• Other study ID #: EC003
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Functional Status
• Muscle Tone

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