Performance Assessement for Paralympic Athletes (PARAPERF)
21 de marzo de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
134
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jean François Toussaint, MD, PhD
- Número de teléfono: +33 (0)1 42 34 82 10
- Correo electrónico: jean-francois.toussaint@aphp.fr
Copia de seguridad de contactos de estudio
- Nombre: François Genêt, MD, PhD
- Número de teléfono: +33 (0)1.47.10.70.68
- Correo electrónico: francois.genet@aphp.fr
Ubicaciones de estudio
-
-
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Garches, Francia, 92380
- Reclutamiento
- Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
14 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dynamic sportive activity
Periodo de tiempo: 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
|
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Dynamic sportive activity
Periodo de tiempo: at 42 months
|
Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.
|
at 42 months
|
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Static sportive activity
Periodo de tiempo: 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
|
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Static sportive activity
Periodo de tiempo: at 42 months
|
Static sportive activity: maximal speed of movement of pression center.
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at 42 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Biomechanical indices of performance: isometric power measurement
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Fatigue assessment
Periodo de tiempo: 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
|
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Blood lactate concentration
Periodo de tiempo: immediately after the intervention
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Blood lactatemia level will be measured by lactometer.
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immediately after the intervention
|
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VO2 peak oxygen uptake
Periodo de tiempo: through study completion, an average of 1 year
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VO2 peak oxygen uptake
|
through study completion, an average of 1 year
|
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Peak breath expiration volume assessment
Periodo de tiempo: through study completion, an average of 1 year
|
VE peak: peak breath expiration volume
|
through study completion, an average of 1 year
|
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Peak cardiac frequence
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Time and distance of deceleration of wheelchair during riding test
Periodo de tiempo: 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
|
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Mechanical indices of wheelchair propulsion - applied forces on handrim during the propulsion
Periodo de tiempo: through study completion, an average of 1 year
|
Applied forces on handrim during the propulsion: measured by force platform.
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through study completion, an average of 1 year
|
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Acceleration profil during the propulsion
Periodo de tiempo: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
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Speed profil during the propulsion
Periodo de tiempo: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: François Genêt, MD, PhD, Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP
- Director de estudio: Jean François Toussaint, MD, PhD, Centre d'Investigation en Médecine du Sport, Hôpital Hôtel Dieu, APHP
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de enero de 2021
Finalización primaria (Anticipado)
1 de junio de 2024
Finalización del estudio (Anticipado)
1 de junio de 2024
Fechas de registro del estudio
Enviado por primera vez
11 de diciembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
6 de febrero de 2021
Publicado por primera vez (Actual)
10 de febrero de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
21 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- APHP201139
- 2020-A02919-30 (Identificador de registro: IDRCB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .