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Functional StatusNCT05331092

Effects of Cryotherapy on Ankle Function

A study testing Cryotherapy in people with Functional Status and Muscle Tone, run by São Paulo State University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 28 yearsHealthy volunteers can take part
Conditions the study is for
Functional Status, Muscle Tone
What is being tested?
Cryotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
30 May 2022to 1 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 28 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 to 28 years old
  • healthy
  • no musculoskeletal complaints

Who cannot join

  • failure to follow protocol
  • complaints of injury or pain during the assessments

Trial locations and contacts

No sites are listed yet.

Flavia A Carvalho, MSc contact

+5518997443624

fla.acarvalho@hotmail.com

About this study

Official title: Effects of Cryotherapy on Ankle Function: Randomized Clinical Trial

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

Read the detailed 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.

Being tested
Cryotherapy
Keywords
Ankle, Cryotherapy, Balance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CryotherapyOther

    20 minutes of cryotherapy on the dominant ankle with ice bags

Study groups in NCT05331092
Study groupRoleWhat they receive
CryotherapyExperimental20 minutes of cryotherapy on the dominant ankle with ice bags
Receives: Other: Cryotherapy
ControlNo intervention20 minutes of rest

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ankle balance

    The Modified Star Excursion Balance Test will measure lower limb reach distance in centimeters

    Measured: Change from baseline to 20 minutes

  2. Ankle balance

    The Modified Star Excursion Balance Test will measure lower limb reach distance in centimeters

    Measured: Change from baseline to 40 minutes

Secondary outcomes (15)

  1. Skin Temperature

    thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)

    Measured: Change from baseline to 20 minutes

  2. Skin Temperature

    thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)

    Measured: Change from baseline to 25 minutes

  3. Skin Temperature

    thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)

    Measured: Change from baseline to 30 minutes

  4. Skin Temperature

    thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)

    Measured: Change from baseline to 35 minutes

  5. Skin Temperature

    thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)

    Measured: Change from baseline to 40 minutes

  6. Thermic Comfort

    a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used

    Measured: Change from baseline to 20 minutes

  7. Thermic Comfort

    a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used

    Measured: Change from baseline to 40 minutes

  8. 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

    Measured: Change from baseline to 20 minutes

  9. 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

    Measured: Change from baseline to 40 minutes

  10. 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

    Measured: Change from baseline to 20 minutes

  11. 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

    Measured: Change from baseline to 25 minutes

  12. 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

    Measured: Change from baseline to 30 minutes

  13. 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

    Measured: Change from baseline to 35 minutes

  14. 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

    Measured: Change from baseline to 40 minutes

  15. 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?"

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2022
  2. Study start30 May 2022 (estimated)
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion1 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05331092
Sponsor's protocol ID
EC003
Status last verified
Apr 2022
First submitted
8 Apr 2022
Last updated
15 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cryotherapy in people with Functional Status and Muscle Tone, run by São Paulo State University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Flavia A Carvalho, MSc (+5518997443624, fla.acarvalho@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ankle balance (time frame: Change from baseline to 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05331092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.

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