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VR Training for Pilots With Neck Pain

23 de mayo de 2018 actualizado por: University of Haifa

Therapeutic Virtual Reality Training for Neck Pain in Israeli Air Force Pilots - A Randomized Controlled Trial

The aim of the proposed study is to investigate the effectiveness of an interactive, virtual reality (VR) training program for pilots compared with standard care. The study will be a randomized controlled trial (RCT) consisting of 60 pilots randomized into one of two groups: standard physiotherapy and medical care vs standard care and VR training. Outcome measures will include subjective scores of pain intensity and global perceived effect; objective measures of range of motion (ROM), neck motion velocity, and motion accuracy; and functional measure of days grounded due to neck pain. Data will be analyzed using ANOVA for within and between groups analyses.

Descripción general del estudio

Descripción detallada

The aim of the proposed study is to investigate the effectiveness of an interactive, virtual reality (VR) training program for pilots compared with standard care. The proposed intervention program includes training in neck range of motion, control, accuracy and coordination and is expected to reduce the prevalence and operational impact of neck pain in the intervention group more effectively than does standard care alone.

The proposed study will be designed as a randomized, controlled trial (RCT). Sixty fighter and helicopter pilots will be randomized into two groups, to receive either standard physiotherapy and medical care or standard care with the addition of interactive, dynamic, controlled training (a self-exercise program) in VR to address the fast, accurate head control required in flying tasks.

Subjective outcome measures will include pain intensity and global perceived effect. Objective measures will include range of motion, motion velocity and accuracy. The functional measure will include days grounded due to neck pain.

Statistical analysis will use independent, repeated measures ANOVA on each parameter, within and between groups. Post hoc comparisons, including several preplanned contrasts, will be performed to assess differences before and after treatment, and the stability of changes over time, in each group. The relationship of risk factors to performance failures will be assessed using multivariate logistic regression analyses.

This study is the first in the Israeli Air Force to evaluate this type of comprehensive, functional intervention program. Such research will dramatically advance the military's health care approach to neck pain, and may be further applied to other populations in and outside the Israeli Defence Force (IDF). This study may serve as a stepping stone to further research related to diagnosis, treatment, and prevention methods during a pilot's active service.

Tipo de estudio

Intervencionista

Inscripción (Actual)

47

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

      • Haifa, Israel, 3498838
        • The Faculty of Social Welfare and Health Sciences
      • Tel Hashomer, Israel
        • Medical Aviation Unit

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • fighter and helicopter pilots from the Israeli Air Force
  • acute, sub-acute, and chronic neck pain, with or without referral to the upper limbs

Exclusion Criteria:

  • neurological disorders (e.g. evidence for positive neurological signs), systemic disease, history of spinal surgery, or any disorders that may limit the ability to exercise

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: control
Patients in the control group will receive standard physiotherapy and medical care, as provided to all patients with neck pain in the aviation medicine clinic. This will reflect the standard care that has been provided to all patients.
physiotherapy and medical care as provided currently
Experimental: intervention
Standard care (as provided to controls) with the addition of virtual reality training (a self-exercise program) using a VR system to address the fast, accurate head control required in flying tasks.

The proposed VR intervention program will provide active training to be performed individually 4 times a week for 20 minutes a session.

The intervention program will be supervised by qualified, experienced physiotherapists, and will include individual training and two follow up meetings during the study period. The intervention program will include strengthening and endurance exercises for the cervical and shoulder girdle muscles. Training will include sensorimotor control and functional, quick, accurate, neck motion, using interactive VR training systems. This type of advanced training is very relevant to the pilots function in the cockpit as it includes interactive tasks aimed to increase range, speed, smoothness, accuracy, and control of cervical motion.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)
Periodo de tiempo: change from baseline at 4 weeks, 3 and 6 months.
Pain intensity was measured using the Visual Analogue Scale (VAS, 0-100mm)
change from baseline at 4 weeks, 3 and 6 months.
Global perceived effect of the provided treatment is measured on a scale from -5 to +5.
Periodo de tiempo: change from baseline at 4 weeks, 3 and 6 months.
Global perceived effect of the provided treatment was measured on a scale from -5 to +5. Zero represented no change, +5 excellent improvement due to the treatment provided, and -5, vast worsening.
change from baseline at 4 weeks, 3 and 6 months.
Functional outcome is measured by the number of grounding days from flying due to neck pain.
Periodo de tiempo: change from baseline at 4 weeks, 3 and 6 months.
The number of days the pilot was grounded due to neck pain.
change from baseline at 4 weeks, 3 and 6 months.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cervical range of motion is measured using the neck VR system (ROM, degrees)
Periodo de tiempo: change from baseline at 4 weeks, 3 and 6 months.
Cervical range of motion (ROM, degrees) is measured using the neck VR system, into flexion, extension, right and left rotation.
change from baseline at 4 weeks, 3 and 6 months.
Cervical motion velocity is measured using the neck VR system (degrees/second)
Periodo de tiempo: change from baseline at 4 weeks, 3 and 6 months.
Cervical motion velocity is measured using the neck VR system (degrees/second) into flexion, extension, right and left rotation.
change from baseline at 4 weeks, 3 and 6 months.
Cervical muscles isometric strength is measures using a dynamometer (Newton)
Periodo de tiempo: change from baseline at 4 weeks, 3 and 6 months.
Cervical muscles isometric strength is measures using a dynamometer (Newton), in the directions of static flexion and extension.
change from baseline at 4 weeks, 3 and 6 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Hilla Sarig-Bahat, PT, PhD, Department of Physical Therapy, University of Haifa

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 septiembre de 2016

Finalización primaria (Actual)

30 de diciembre de 2017

Finalización del estudio (Actual)

30 de diciembre de 2017

Fechas de registro del estudio

Enviado por primera vez

5 de octubre de 2016

Primero enviado que cumplió con los criterios de control de calidad

28 de noviembre de 2016

Publicado por primera vez (Estimar)

1 de diciembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de mayo de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

23 de mayo de 2018

Última verificación

1 de junio de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • UHaifaAF

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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