- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05331092
Effekter av kryoterapi på fotledsfunktion
Effekter av kryoterapi på fotledsfunktion: Randomiserad klinisk prövning
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
São Paulo
-
Presidente Prudente, São Paulo, Brasilien, 19060-900
- Unesp - Faculdade de Ciências e Tecnologia (FCT)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Control
20 minutes of rest |
|
|
Experimentell: Cryotherapy
20 minutes of cryotherapy on the dominant ankle with ice bags |
20 minutes of cryotherapy on the dominant ankle with ice bags |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ankle balance
Tidsram: Change from baseline to 20 minutes
|
The Modified Star Excursion Balance Test will measure lower limb reach distance in centimeters |
Change from baseline to 20 minutes
|
|
Ankle balance
Tidsram: Change from baseline to 40 minutes
|
The Modified Star Excursion Balance Test will measure lower limb reach distance in centimeters |
Change from baseline to 40 minutes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Thermic Comfort
Tidsram: Change from baseline to 20 minutes
|
a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used |
Change from baseline to 20 minutes
|
|
Thermic Comfort
Tidsram: Change from baseline to 40 minutes
|
a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used |
Change from baseline to 40 minutes
|
|
Skin Temperature
Tidsram: Change from baseline to 20 minutes
|
thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) |
Change from baseline to 20 minutes
|
|
Skin Temperature
Tidsram: Change from baseline to 25 minutes
|
thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) |
Change from baseline to 25 minutes
|
|
Skin Temperature
Tidsram: Change from baseline to 30 minutes
|
thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) |
Change from baseline to 30 minutes
|
|
Skin Temperature
Tidsram: Change from baseline to 35 minutes
|
thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) |
Change from baseline to 35 minutes
|
|
Skin Temperature
Tidsram: Change from baseline to 40 minutes
|
thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) |
Change from baseline to 40 minutes
|
|
Balance Perception
Tidsram: Change from baseline to 20 minutes
|
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
|
|
Balance Perception
Tidsram: Change from baseline to 40 minutes
|
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
|
|
muscle tone
Tidsram: Change from baseline to 20 minutes
|
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
|
|
muscle tone
Tidsram: Change from baseline to 25 minutes
|
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
|
|
muscle tone
Tidsram: Change from baseline to 30 minutes
|
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
|
|
muscle tone
Tidsram: Change from baseline to 35 minutes
|
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
|
|
muscle tone
Tidsram: Change from baseline to 40 minutes
|
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
|
|
Beliefs
Tidsram: baseline
|
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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Carlos M Pastre, PhD, São Paulo State University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EC003
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