Efficacy of Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players on the Field
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in creatinine kinase level
研究概览
简要总结
Competitive team sports calendars are becoming increasingly compressed, generating changes in the effort-recovery cycle. Given this new situation, it seems necessary to analyze how it affects the physiological and performance level of semi-professional players, as well as how to observe if the non-invasive neuromodulation technique NESA helps the neuroefficiency and concentration values of said players.
详细描述
The design of this study is a randomised, triple blind clinical trial with placebo control.
The general configuration of the study consists of capturing the second basketball team of FC BARCELONA. For this, a double-blind capture system will be available (neither the specialist nor those responsible for recovery will know which patients are entering the complementary treatment) and two NESA XSIGNAL® devices operating in double-blind (due to the imperceptivity of the stimulation performed, there will be a placebo machine and another that applies the treatment).
At the end of the study, the results obtained between the different groups of patients will be able to be compared; those additionally treated with a device, those treated with a placebo device and those in the standard rehabilitation procedure without a device.
The variables of the study will be collected at three time points: before the intervention, during the intervention and at the end of the intervention.
The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p <0.05
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Belonging to the team
- •Participants do not present injury or pathology during the study
- •In normal conditions and mentally competent to participate in the study.
- •In condition to complete the study questionnaires.
排除标准
- •Present some of the contraindications for a treatment with non-invasive neuromodulation: pacemakers, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia.
- •Not having signed the informed consent.
- •Present any injury or pathology during the study
结局指标
主要结局
Changes in creatinine kinase level
时间窗: 48 hours before the first match, immediately after the match and 48 hours after the match
For the analysis of these biomarkers, a saliva sample, collected with Salivette containers will be necessary. Once the sample is obtained, it will be kept following the necessary security protocols and sent to a laboratory for further analysis.
次要结局
- Cardiovascular parameters: heart rate variability (VHR)(Up to 6 weeks)
- Kinematic demand parameters (external load) II(During the match and all the intervention ( 6 weeks))
- Perceptual parameters(Up to 6 weeks)
- Kinematic demand parameters (external load) I(Through study completion, an average of 6 weeks)
- Kinematic demand parameters (external load) IV(Through study completion, an average of 6 weeks)
- Kinematic demand parameters (external load) III(During all the intervention ( 6 weeks))
- Perceptual parameters II(During all the intervention. Up to 6 weeks)
研究者
Aníbal Báez Suárez
Principal Investigator
University of Las Palmas de Gran Canaria