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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01870414
Other study ID # U1111-1143-6567
Secondary ID
Status Completed
Phase N/A
First received May 28, 2013
Last updated June 5, 2013
Start date March 2012
Est. completion date June 2013

Study information

Verified date June 2013
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2013
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
cryotherapy by immersion
the dominant leg was immersed in cold water for 20 minutes [2, 17], temperature of 4º C [22, 24], water level at 20 cm

Locations

Country Name City State
Brazil University of Sao Paulo Ribeirão Preto São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years No
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