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Computer-vision Aided Community Back Pain Physiotherapy Services (CV)

20 de mayo de 2021 actualizado por: Helen Dawes, Oxford Brookes University
Back pain affects one-third of the UK population every year with a huge impact on the health service and economy. 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. 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.

Descripción general del estudio

Estado

Reclutamiento

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

De observación

Inscripción (Anticipado)

100

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: Helen Dawes, PhD
  • Número de teléfono: 01865483293
  • Correo electrónico: hdawes@brookes.ac.uk

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

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 a 100 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Healthy participants and participants with non-specific back pain will be recruited via advertisement through networks associated with the research team members. Participants with AxSpa will initially be recruited from the Oxford area by The National Axial Spondyloarthritis Society (NASS) promotion.

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

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

  • Modelos observacionales: Control de caso
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿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
Concurrent validity of lumbar spine lateral flexion measurement by the CV system compared to physiotherapy measurement.
1 minute

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.
1 minute
Movement of Cervical rotation
Periodo de tiempo: 1 minute
Concurrent validity of: Cervical rotation seated measurement by the CV system compared to physiotherapy measurement.
1 minute
Movement of Hip internal rotation
Periodo de tiempo: 1 minute
Concurrent validity of: Hip internal rotation seated measurement by the CV system compared to physiotherapy measurement.
1 minute
Movement of Hip abduction
Periodo de tiempo: 1 minute
Concurrent validity of: Hip abduction standing measurement by the CV system compared to physiotherapy measurement.
1 minute
Movement of Shoulder flexion
Periodo de tiempo: 1 minute
Concurrent validity of: Shoulder flexion measurement by the CV system compared to physiotherapy measurement.
1 minute
Movement 6
Periodo de tiempo: 1 minute
Concurrent validity of: Chest expansion measurement by the CV system compared to physiotherapy measurement.
1 minute
Movement of Sit-to-stand
Periodo de tiempo: 1 minute
Concurrent validity of Sit-to-stand measurement by the CV system compared to physiotherapy measurement.
1 minute
Standing posture spinal kyphosis
Periodo de tiempo: 1 minute
Posture as measured by spinal kyphosis
1 minute
Standing posture tragus to ear
Periodo de tiempo: 1 minute
Posture as measured by tragus to walk
1 minute
Leg strength
Periodo de tiempo: 1 minute
5 time sit to stand
1 minute

Colaboradores e Investigadores

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

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)

1 de abril de 2021

Finalización primaria (Anticipado)

1 de enero de 2022

Finalización del estudio (Anticipado)

1 de junio de 2022

Fechas de registro del estudio

Enviado por primera vez

15 de mayo de 2021

Primero enviado que cumplió con los criterios de control de calidad

19 de mayo de 2021

Publicado por primera vez (Actual)

20 de mayo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de mayo de 2021

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

20 de mayo de 2021

Última verificación

1 de mayo de 2021

Más información

Términos relacionados con este estudio

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)?

No

Descripción del plan IPD

Direct access will be granted to authorised representatives from the Sponsor and host institution for monitoring and/or audit of the study to ensure compliance with regulations.

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. .

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