An Investigation of Return to Play Exertion Protocol in Concussed Adolescents
14 de enero de 2019 actualizado por: Anthony P. Kontos, Ph.D., University of Pittsburgh
An Investigation of Return to Play Exertion Protocol in Concussed Adolescents
Descripción general del estudio
Estado
Retirado
Condiciones
Intervención / Tratamiento
Descripción detallada
Written informed parental consent and assent will be obtained for all subjects.
The PI or Co-I will administer ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing), the PCSS (Post Concussion Symptom Scale), and the VOMS (Vestibular Ocular Motor Screening) to each subject during their first clinical visit.
In addition to demographic variables such as age and gender, groups will be matched based on ImPACT and VOMS performance as well as the number, type, and severity of symptoms reported on the PCSS.
Subjects will be assigned to receive either the currently accepted standard of care (Heart Rate Exertion group) or the newly developed exertion protocol (Dynamic Exertion Group).
Participants will be matched according to PCSS total, VOMS symptom report, and by demographic variables including age and gender.
The first participant will be assigned to the dynamic exertion group and the next to the standard of care group, alternating accordingly as covariates allow.
The physical therapists will be responsible for administering the assigned exertion protocol to each subject across four time points (one week between each session).
Follow-up data regarding recovery time (i.e., clinical return to normal activity) will also be collected.
Neurocognitive testing will take place on 3-4 week intervals as is consistent with clinical practice.
The current study will include a pre-exertion neurocognitive evaluation and a post-exertion protocol neurocognitive evaluation.
Tipo de estudio
Intervencionista
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.
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15203
- UMPC Sports Medicine Concussion Research Program
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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 a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 14-17 years of age
- Referred to exertion physical therapy within 6 weeks of sport related concussion
Exclusion Criteria:
- Family history of mood or anxiety disorder
- Diagnosis or treatment of migraine
- Diagnosed history of learning disability, ADHD (Attention Deficit Hyperactivity Disorder)
- Concussion history of 3 or more
- Other factors that would prevent subject from completing exertion protocol
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Standard Physical Therapy Protocol
Regular Physical Therapy Protocol.
Standard treadmill running, monitoring heart rate
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Standard treadmill running, monitoring heart rate
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Experimental: Exertion Physical Therapy Protocol
Exertional Physical Therapy Protocol.
Dynamic exertion protocol includes the treadmill running aspect, but also incorporates other exercises that involve lateral movement (e.g., side lunges, lateral speed training exercises) as well as planar changes (e.g., burpees, squat thrusts) .
Recovery on these exercises is measured based on time subjects are able to tolerate the exertion without symptom increase.
Across all exertion protocols additional measures of subjective physical effort and objective measurement of heart rate are taken.
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By contrast, the dynamic exertion protocol includes the treadmill running aspect, but also incorporates other exercises that involve lateral movement (e.g., side lunges, lateral speed training exercises) as well as planar changes (e.g., burpees, squat thrusts) .
Recovery on these exercises is measured based on time subjects are able to tolerate the exertion without symptom increase.
Across all exertion protocols additional measures of subjective physical effort and objective measurement of heart rate are taken.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Efficacy of the current standard of care exertion protocol versus a newly developed program that emphasizes dynamic movement and sport-specific activities as measured by patient symtom scales and neurocognitive testing performance
Periodo de tiempo: 4 weeks
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To empirically assess the efficacy of the current standard of care as it relates to a gradual increase in physical activity relative to a newly developed program.
The current standard of care focuses on heart rate and duration of physical activity where all athletes are progressed in the same fashion based on ability to tolerate symptoms while running on a treadmill; by contrast, the newly developed program emphasizes dynamic movement (incorporating lateral movement and planar changes in addition to treadmill running) that more closely approximate movements made while playing sports where rehabilitation is based on specific symptom deficits.
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4 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
1 de enero de 2016
Finalización primaria (Anticipado)
20 de enero de 2019
Finalización del estudio (Anticipado)
20 de enero de 2019
Fechas de registro del estudio
Enviado por primera vez
26 de febrero de 2015
Primero enviado que cumplió con los criterios de control de calidad
10 de marzo de 2015
Publicado por primera vez (Estimar)
17 de marzo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
14 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- PRO14070006
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. .