Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-26 @ 8:26 PM
Study NCT ID:
NCT05331092
Status:
UNKNOWN
Last Update Posted:
2022-04-15
First Post:
2022-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cryotherapy on Ankle Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ankle balance', 'timeFrame': 'Change from baseline to 20 minutes', 'description': 'The Modified Star Excursion Balance Test will measure lower limb reach distance in centimeters'}, {'measure': 'Ankle balance', 'timeFrame': 'Change from baseline to 40 minutes', 'description': 'The Modified Star Excursion Balance Test will measure lower limb reach distance in centimeters'}], 'secondaryOutcomes': [{'measure': 'Skin Temperature', 'timeFrame': 'Change from baseline to 20 minutes', 'description': 'thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)'}, {'measure': 'Skin Temperature', 'timeFrame': 'Change from baseline to 25 minutes', 'description': 'thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)'}, {'measure': 'Skin Temperature', 'timeFrame': 'Change from baseline to 30 minutes', 'description': 'thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)'}, {'measure': 'Skin Temperature', 'timeFrame': 'Change from baseline to 35 minutes', 'description': 'thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)'}, {'measure': 'Skin Temperature', 'timeFrame': 'Change from baseline to 40 minutes', 'description': 'thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)'}, {'measure': 'Thermic Comfort', 'timeFrame': 'Change from baseline to 20 minutes', 'description': 'a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used'}, {'measure': 'Thermic Comfort', 'timeFrame': 'Change from baseline to 40 minutes', 'description': 'a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used'}, {'measure': 'Balance Perception', 'timeFrame': 'Change from baseline to 20 minutes', 'description': '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'}, {'measure': 'Balance Perception', 'timeFrame': 'Change from baseline to 40 minutes', 'description': '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'}, {'measure': 'muscle tone', 'timeFrame': 'Change from baseline to 20 minutes', 'description': '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'}, {'measure': 'muscle tone', 'timeFrame': 'Change from baseline to 25 minutes', 'description': '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'}, {'measure': 'muscle tone', 'timeFrame': 'Change from baseline to 30 minutes', 'description': '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'}, {'measure': 'muscle tone', 'timeFrame': 'Change from baseline to 35 minutes', 'description': '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'}, {'measure': 'muscle tone', 'timeFrame': 'Change from baseline to 40 minutes', 'description': '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'}, {'measure': 'Beliefs', 'timeFrame': 'baseline', 'description': '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?"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankle', 'Cryotherapy', 'Balance'], 'conditions': ['Functional Status', 'Muscle Tone']}, 'descriptionModule': {'briefSummary': "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", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 28 years old\n* healthy\n* no musculoskeletal complaints\n\nExclusion Criteria:\n\n* failure to follow protocol\n* complaints of injury or pain during the assessments'}, 'identificationModule': {'nctId': 'NCT05331092', 'briefTitle': 'Effects of Cryotherapy on Ankle Function', 'organization': {'class': 'OTHER', 'fullName': 'São Paulo State University'}, 'officialTitle': 'Effects of Cryotherapy on Ankle Function: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'EC003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryotherapy', 'description': '20 minutes of cryotherapy on the dominant ankle with ice bags', 'interventionNames': ['Other: Cryotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '20 minutes of rest'}], 'interventions': [{'name': 'Cryotherapy', 'type': 'OTHER', 'description': '20 minutes of cryotherapy on the dominant ankle with ice bags', 'armGroupLabels': ['Cryotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Flavia A Carvalho, MSc', 'role': 'CONTACT', 'email': 'fla.acarvalho@hotmail.com', 'phone': '+5518997443624'}], 'overallOfficials': [{'name': 'Carlos M Pastre, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'São Paulo State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'São Paulo State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Flávia Carvalho', 'investigatorAffiliation': 'São Paulo State University'}}}}