- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04895826
Computer-vision Aided Community Back Pain Physiotherapy Services (CV)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Back pain affects one-third of the UK population every year with a huge impact on the health service and economy. One specific back pain condition is Axial Spondyloarthropathy (AxSpa), which is an inflammatory spinal arthritis that causes pain and stiffness. This life-long condition presents in the early twenties as 'regular' back pain. Due to its similarity to other back pain conditions, there is an average 8.5-year delay to diagnosis. The aim of this study is to test the validity of a computer-vision (CV) technology that uses cameras on phones/tablets/webcams to assess a person's movement and function with the ultimate goal to use the CV system to screen for back pain conditions, such as AxSpa. The CV system development is led by the GoodBoost Wellbeing Limited and The National Axial Spondyloarthritis Society (NASS) is supporting the recruitment of people living with AxSpa.
The CV system that has been developed is a form of artificial intelligence video analysis which is able to automatically measure specific functional movements captured on video. To validate this CV system, this study is designed to compare it to the clinical gold standard measurement by a physiotherapist. Participants with and without back pain will be included in the study and they will be asked to perform standard functional movements that would be used for a physiotherapy assessment for a back condition. The participants will also perform these movements in front of a camera for video recordings to be analysed by the CV system. The measurements by the CV system will be compared to the measurements by the physiotherapist. Additionally, participants will perform and record videos of the same set of movements at home to test the feasibility of the CV system in a home environment.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Helen Dawes, PhD
- Número de teléfono: 01865483293
- Correo electrónico: hdawes@brookes.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Sarah Quinton, PhD
- Correo electrónico: Squinton@brookes.ac.uk
Ubicaciones de estudio
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Oxford, Reino Unido, Ox3 0bp
- Reclutamiento
- Oxford Brookes
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Contacto:
- Mae Mansoubi, PhD
- Correo electrónico: mmansoubi@brookes.ac.uk
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Contacto:
- Helen Dawes, PhD
- Correo electrónico: hdawes@brookes.ac.uk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
● The participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- For back pain group: diagnosed with AxSpa or long-standing non-specific LBP
- For healthy group: healthy with no long-standing back pain
- For the home setting, the participant must be capable of uploading videos from a smartphone or webcam.
Exclusion Criteria:
● Has had surgery within 6 months of registration
- Unable to stand independently
- Unable to pass screening questions to participate in physical activity
- Serious neurological condition preventing normal movement or walking ability
- Any severe medical conditions, such as cardiovascular disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Back pain and no back pain
Participants with and without back pain will be included in the study and they will be asked to perform standard functional movements that would be used for a physiotherapy assessment for a back condition.
The participants will also perform these movements in front of a camera for video recordings to be analysed by the CV system.
The measurements by the CV system will be compared to the measurements by the physiotherapist.
Additionally, participants will perform and record videos of the same set of movements at home to test the feasibility of the CV system in a home environment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Primary movement Lumbar spine lateral flexion
Periodo de tiempo: 1 minute
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Concurrent validity of lumbar spine lateral flexion measurement by the CV system compared to physiotherapy measurement.
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1 minute
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Movement of Lumbar global flexion
Periodo de tiempo: 1 minute
|
Concurrent validity of: Lumbar global flexion measurement by the CV system compared to physiotherapy measurement.
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1 minute
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Movement of Cervical rotation
Periodo de tiempo: 1 minute
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Concurrent validity of: Cervical rotation seated measurement by the CV system compared to physiotherapy measurement.
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1 minute
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Movement of Hip internal rotation
Periodo de tiempo: 1 minute
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Concurrent validity of: Hip internal rotation seated measurement by the CV system compared to physiotherapy measurement.
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1 minute
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Movement of Hip abduction
Periodo de tiempo: 1 minute
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Concurrent validity of: Hip abduction standing measurement by the CV system compared to physiotherapy measurement.
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1 minute
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Movement of Shoulder flexion
Periodo de tiempo: 1 minute
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Concurrent validity of: Shoulder flexion measurement by the CV system compared to physiotherapy measurement.
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1 minute
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Movement 6
Periodo de tiempo: 1 minute
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Concurrent validity of: Chest expansion measurement by the CV system compared to physiotherapy measurement.
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1 minute
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Movement of Sit-to-stand
Periodo de tiempo: 1 minute
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Concurrent validity of Sit-to-stand measurement by the CV system compared to physiotherapy measurement.
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1 minute
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Standing posture spinal kyphosis
Periodo de tiempo: 1 minute
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Posture as measured by spinal kyphosis
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1 minute
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Standing posture tragus to ear
Periodo de tiempo: 1 minute
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Posture as measured by tragus to walk
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1 minute
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Leg strength
Periodo de tiempo: 1 minute
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5 time sit to stand
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1 minute
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201429
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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