Performance Assessement for Paralympic Athletes (PARAPERF)
2022年3月21日 更新者：Assistance Publique - Hôpitaux de Paris
Evaluation of Performance in Paralympic Athletes: Performance Outcomes in Sports
The primary objective of the study: improvement of sportive performances by quantification and performances monitoring of paralympic athletes.
The secondary objectives of the study:
- quantification and performances monitoring of mechanical performances during the filed tests, the laboratory analysis and the sportive competitions;
- quantification and performances monitoring of physiological performances during the filed tests, the laboratory analysis and the sportive competitions;
- quantification and risk monitoring of discipline-relative musculo-squeletic troubles, caused by training or using of sportive equipment;
- quantification and mechanical monitoring by the made-to-measure or usual sportive material.
研究概览
详细说明
The sportive performance results from a range of determinations such as: physiological, biomechanical, morphological, psychological, social and environmental factors.
The interactions between athletes, equipment, training and environment influences the development of athletes' performance.
In the context of the coming Paris 2024 Paralympic Games, the performance construction for the exploration, the quantification and the management of all factors is an commun objective between sportive team, medical team and researchers.
研究类型
介入性
注册 (预期的)
134
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jean François Toussaint, MD, PhD
- 电话号码：+33 (0)1 42 34 82 10
- 邮箱：jean-francois.toussaint@aphp.fr
研究联系人备份
- 姓名：François Genêt, MD, PhD
- 电话号码：+33 (0)1.47.10.70.68
- 邮箱：francois.genet@aphp.fr
学习地点
-
-
-
Garches、法国、92380
- 招聘中
- Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
14年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- High-lever paralympic athletes registered on the ministerial list or selected by Parasport Federation of France or Shooting Federation of France;
- Aged >= 14 years;
- Informed consent signed by adult athlete or by holder of parental authority or guardian for minor athlete;
- Covered by social security system.
Exclusion Criteria:
- Temporary or definitive contraindication to the practice of the affected sport activity;
- Undergoing anti-coagulated treatments;
- Cognitive disabilities conducting impossibility to participating to clinical trial, such as serious cognitive troubles, behaviors troubles, psychic troubles or upgraded curatorship needing;
- Under guardianship or judicial decision;
- Ongoing pregnancy.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Parasportives of various disciplines
|
Standardization of evaluation and clinical and sportive follow-up of athletes. Made-to-measure technical supports will be tested regarding the Paralympic regulations. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dynamic sportive activity
大体时间：through study completion, an average of 1 year
|
Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.
|
through study completion, an average of 1 year
|
|
Dynamic sportive activity
大体时间：at 42 months
|
Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.
|
at 42 months
|
|
Static sportive activity
大体时间：through study completion, an average of 1 year
|
Static sportive activity: maximal speed of movement of pression center.
|
through study completion, an average of 1 year
|
|
Static sportive activity
大体时间：at 42 months
|
Static sportive activity: maximal speed of movement of pression center.
|
at 42 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Biomechanical indices of performance: isometric power measurement
大体时间：through study completion, an average of 1 year
|
Isometric power will be measured by MicroFet & handgrip of 26 measures, advice for healthcare professionals to measure handgrip strength forces to test and document grip deficits and to evaluate consistency of effort.
|
through study completion, an average of 1 year
|
|
Biomechanical indices of performance: arms and shoulder's Strength
大体时间：through study completion, an average of 1 year
|
Arms and shoulder's Strength will be measured by force platform.
|
through study completion, an average of 1 year
|
|
Physiological indices of performance: maximal aerobic speed (MAS)
大体时间：Twice through study completion, an average of 42 months
|
Maximal aerobic speed (MAS) will be measured by Repetition Per Minute on a Arm ergometer.
|
Twice through study completion, an average of 42 months
|
|
Physiological indices of performance: maximal aerobic power
大体时间：Twice through study completion, an average of 42 months
|
Maximal aerobic power will be measured by following Watts fluctuation during the incremental hand-biking test.
|
Twice through study completion, an average of 42 months
|
|
Fatigue assessment
大体时间：Twice through study completion, an average of 42 months
|
Fatigue assessment will be measured by Fatigue Index (Power max ratio).
|
Twice through study completion, an average of 42 months
|
|
Blood lactate concentration
大体时间：immediately after the intervention
|
Blood lactatemia level will be measured by lactometer.
|
immediately after the intervention
|
|
VO2 peak oxygen uptake
大体时间：through study completion, an average of 1 year
|
VO2 peak oxygen uptake
|
through study completion, an average of 1 year
|
|
Peak breath expiration volume assessment
大体时间：through study completion, an average of 1 year
|
VE peak: peak breath expiration volume
|
through study completion, an average of 1 year
|
|
Peak cardiac frequence
大体时间：through study completion, an average of 1 year
|
CF: peak cardiac frequence
|
through study completion, an average of 1 year
|
|
Musculo-squeletic troubles risks measurement
大体时间：through study completion, an average of 1 year
|
Musculo-squeletic troubles risks will be measured by medical following and clinical method of functional assessment of the shoulder (i.e.
"Constant scale").
|
through study completion, an average of 1 year
|
|
Time and distance of deceleration of wheelchair during riding test
大体时间：through study completion, an average of 1 year
|
Time and distance of deceleration of wheelchair during riding test: measured by signal analysis of instrumented wheelchair (inertial control units).
|
through study completion, an average of 1 year
|
|
Mechanical indices of wheelchair propulsion - applied forces on handrim during the propulsion
大体时间：through study completion, an average of 1 year
|
Applied forces on handrim during the propulsion: measured by force platform.
|
through study completion, an average of 1 year
|
|
Acceleration profil during the propulsion
大体时间：through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
|
|
Speed profil during the propulsion
大体时间：through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：François Genêt, MD, PhD、Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP
- 研究主任：Jean François Toussaint, MD, PhD、Centre d'Investigation en Médecine du Sport, Hôpital Hôtel Dieu, APHP
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年1月8日
初级完成 (预期的)
2024年6月1日
研究完成 (预期的)
2024年6月1日
研究注册日期
首次提交
2020年12月11日
首先提交符合 QC 标准的
2021年2月6日
首次发布 (实际的)
2021年2月10日
研究记录更新
最后更新发布 (实际的)
2022年3月22日
上次提交的符合 QC 标准的更新
2022年3月21日
最后验证
2022年3月1日
更多信息
与本研究相关的术语
其他研究编号
- APHP201139
- 2020-A02919-30 (注册表标识符：IDRCB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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研究美国 FDA 监管的设备产品
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