- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04895826
Computer-vision Aided Community Back Pain Physiotherapy Services (CV)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Helen Dawes, PhD
- Numero di telefono: 01865483293
- Email: hdawes@brookes.ac.uk
Backup dei contatti dello studio
- Nome: Sarah Quinton, PhD
- Email: Squinton@brookes.ac.uk
Luoghi di studio
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Oxford, Regno Unito, Ox3 0bp
- Reclutamento
- Oxford Brookes
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Contatto:
- Mae Mansoubi, PhD
- Email: mmansoubi@brookes.ac.uk
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Contatto:
- Helen Dawes, PhD
- Email: hdawes@brookes.ac.uk
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Primary movement Lumbar spine lateral flexion
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Movement of Lumbar global flexion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 minute
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5 time sit to stand
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1 minute
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 201429
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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