Individual AdjustmentNCT01870414
Electromyographic Analysis And Body Balance In The Use Of Athletes After Cryotherapy By Immersion Ankle
A study testing cryotherapy by immersion in people with Individual Adjustment and Itch; Athlete, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The influence of cryotherapy on ankle motor control and balance of athletes is controversial. The aim of this study is to assess the neuromuscular response of the dominant leg and body balance basketball athletes after application of cryotherapy. The sample is distributed into two groups. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Individual Adjustment, Itch; Athlete
- What is being tested?
- cryotherapy by immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Jun 2013
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Inclusion Criteria:Healthy, active individuals and athletes basketball. -
Exclusion Criteria:patients with muscle or joint injuries in the lower limbs in the last six months; metabolic diseases, rheumatic and orthopedic disabling; patients with balance disorders or cognitive; individuals to submit complaints of muscle fatigue at the time of the tests or they needed the use of stabilizers to realize them; subjects with skin lesions of the lower extremities, hypersensitivity to cold and suffering from Diabetes Mellitus.
-
Trial locations and contacts
1 site in 1 country.
About this study
The influence of cryotherapy on ankle motor control and balance of athletes is controversial. The aim of this study is to assess the neuromuscular response of the dominant leg and body balance basketball athletes after application of cryotherapy. The sample is distributed into two groups. Group one will consist of 20 basketball players without a history of ankle sprains in the past 12 months and no complaints of instability in this joint, and group two, 20 non-athletes, active, no complaints in the lower limb in the last 12 months. Will perform the inversion movements and single-leg hop for the analysis of the electromyographic signal of anterior tibial, peroneal, gastrocnemius (lateral), rectus femoris, hamstrings and gluteus medius. Will also be performed kinematic analysis in search of body balance and range of motion of the joints of the lower limbs. And yet, the analysis of the plantar support and ground reaction force. After the initial collection of the data subjects will be submitted to the application of cryotherapy by immersion in a time of 20 minutes, with a temperature of 6 ± 2 degrees Celsius. Data collection will be held in pre, 0, 10, 20 and 30 minutes after application of cryotherapy. The data will be statistically analyzed to compare the results in collection times within and between groups. The significance level is set at 5%. The data support the intended use of cryotherapy in motor control of the inversion movement, jump and balance of athletes.
Read the detailed description
Forty male subjects, aged 21.6 (±3.2) yr, 177.9 (±7.9) cm tall, 82.8 (±19.3) Kg body weight and 25.9 (±4.8) Kg.m-2 body mass index (BMI) were evaluated. Skin surface temperature before and after cold-water immersion was 27.7(±3)°C and 7.1 (±1)°C, respectively (p=0,0001).
- Conditions
- Individual Adjustment, Itch; Athlete
- Being tested
- cryotherapy by immersion
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapy by immersionOther
Also called Cryoimmersion, 20 minutes, temperature was 4C.
the dominant leg was immersed in cold water for 20 minutes [2, 17], temperature of 4º C [22, 24], water level at 20 cm
| Study group | Role | What they receive |
|---|---|---|
| cryotherapy by immersion | Other | the dominant leg was immersed in cold water for 20 minutes [2, 17], temperature of 4º C [22, 24], water level at 20 cm. Receives: Other: cryotherapy by immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cryoimmersion decreases neuromuscular response of lower limb after ankle inversion
The peak values of the electromyographic signal amplitude (RMS) were obtained from thirty-five healthy, active university subjects after the use of a tilt platform to force the ankle into a 30º of inversion before (pre), and immediately after (post) 10, 20, and 30 minutes, followed by cold-water immersion at 4ºC, for 20 minutes. Shapiro-Wilk test, Repeated Measure Analysis and Bonferroni post-hoc test provided the results. Peak RMS values were significantly lower at all times after cold-water immersion when compared to prior application for all muscles, except in the post-immediate time for GM. There was a decrease in muscular response to the ankle inversion movement after cooling, with residual effect of up to 30 minutes. Therefore, special care should be taken by those involved in sports activities.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startMar 2012
- Primary completionMar 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Individual AdjustmentStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
- Investigators
- Christiane Macedo, master, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870414
- Sponsor's protocol ID
- U1111-1143-6567
- Status last verified
- Jun 2013
- First submitted
- 28 May 2013
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Macedo CS, Alonso CS, Liporaci RF, Vieira F, Guirro RR. Cold water immersion of the ankle decreases neuromuscular response of lower limb after inversion movement. Braz J Phys Ther. 2014 Jan-Feb;18(1):93-7. doi: 10.1590/s1413-35552012005000132. Epub 2014 Jan 8.
PubMed 24675918
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Analysis And Body Balance In The Use Of Athletes After Cryotherapy By Immersion Ankle
- ClinicalTrials.gov ID
- NCT01870414
- Acronym / sponsor ID
- U1111-1143-6567
- Conditions
- Individual Adjustment, Itch; Athlete
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The influence of cryotherapy on ankle motor control and balance of athletes is controversial. The aim of this study is to assess the neuromuscular response of the dominant leg and body balance basketball athletes after application of cryotherapy. The sample is distributed into two groups. Group one will consist of 20 basketball players without a history of ankle sprains in the past 12 months and no complaints of instability in this joint, and group two, 20 non-athletes, active, no complaints in the lower limb in the last 12 months. Will perform the inversion movements and single-leg hop for the analysis of the electromyographic signal of anterior tibial, peroneal, gastrocnemius (lateral), rectus femoris, hamstrings and gluteus medius. Will also be performed kinematic analysis in search of body balance and range of motion of the joints of the lower limbs. And yet, the analysis of the plantar support and ground reaction force. After the initial collection of the data subjects will be submitted to the application of cryotherapy by immersion in a time of 20 minutes, with a temperature of 6 ± 2 degrees Celsius. Data collection will be held in pre, 0, 10, 20 and 30 minutes after application of cryotherapy. The data will be statistically analyzed to compare the results in collection times within and between groups. The significance level is set at 5%. The data support the intended use of cryotherapy in motor control of the inversion movement, jump and balance of athletes.
Detailed description
Forty male subjects, aged 21.6 (±3.2) yr, 177.9 (±7.9) cm tall, 82.8 (±19.3) Kg body weight and 25.9 (±4.8) Kg.m-2 body mass index (BMI) were evaluated. Skin surface temperature before and after cold-water immersion was 27.7(±3)°C and 7.1 (±1)°C, respectively (p=0,0001).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cryotherapy by immersion | Other | Other: cryotherapy by immersionthe dominant leg was immersed in cold water for 20 minutes [2, 17], temperature of 4º C [22, 24], water level at 20 cm. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryotherapy by immersionAlso: Cryoimmersion, 20 minutes, temperature was 4C.the dominant leg was immersed in cold water for 20 minutes [2, 17], temperature of 4º C [22, 24], water level at 20 cm | Other | cryotherapy by immersion |
Primary outcome
Cryoimmersion decreases neuromuscular response of lower limb after ankle inversion
Time frame: 2 years
The peak values of the electromyographic signal amplitude (RMS) were obtained from thirty-five healthy, active university subjects after the use of a tilt platform to force the ankle into a 30º of inversion before (pre), and immediately after (post) 10, 20, and 30 minutes, followed by cold-water immersion at 4ºC, for 20 minutes. Shapiro-Wilk test, Repeated Measure Analysis and Bonferroni post-hoc test provided the results. Peak RMS values were significantly lower at all times after cold-water immersion when compared to prior application for all muscles, except in the post-immediate time for GM. There was a decrease in muscular response to the ankle inversion movement after cooling, with residual effect of up to 30 minutes. Therefore, special care should be taken by those involved in sports activities.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2013.
- Derived from this study: PubMed 24675918Macedo CS, Alonso CS, Liporaci RF, Vieira F, Guirro RR. Cold water immersion of the ankle decreases neuromuscular response of lower limb after inversion movement. Braz J Phys Ther. 2014 Jan-Feb;18(1):93-7. doi: 10.1590/s1413-35552012005000132. Epub 2014 Jan 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Macedo, master principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy by immersion in people with Individual Adjustment and Itch; Athlete, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cryoimmersion decreases neuromuscular response of lower limb after ankle inversion (time frame: 2 years). 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 NCT01870414, which also lists 1 linked publication.
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 6 Jun 2013.