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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04895826
Other study ID # 201429
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date June 2022

Study information

Verified date May 2021
Source Oxford Brookes University
Contact Helen Dawes, PhD
Phone 01865483293
Email hdawes@brookes.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2022
Est. primary completion date January 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Oxford Brookes Oxford

Sponsors (3)

Lead Sponsor Collaborator
Oxford Brookes University Good Boost Wellbeing, National Axial Spondyloarthritis Society

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary movement Lumbar spine lateral flexion Concurrent validity of lumbar spine lateral flexion measurement by the CV system compared to physiotherapy measurement. 1 minute
Secondary Movement of Lumbar global flexion Concurrent validity of: Lumbar global flexion measurement by the CV system compared to physiotherapy measurement. 1 minute
Secondary Movement of Cervical rotation Concurrent validity of: Cervical rotation seated measurement by the CV system compared to physiotherapy measurement. 1 minute
Secondary Movement of Hip internal rotation Concurrent validity of: Hip internal rotation seated measurement by the CV system compared to physiotherapy measurement. 1 minute
Secondary Movement of Hip abduction Concurrent validity of: Hip abduction standing measurement by the CV system compared to physiotherapy measurement. 1 minute
Secondary Movement of Shoulder flexion Concurrent validity of: Shoulder flexion measurement by the CV system compared to physiotherapy measurement. 1 minute
Secondary Movement 6 Concurrent validity of: Chest expansion measurement by the CV system compared to physiotherapy measurement. 1 minute
Secondary Movement of Sit-to-stand Concurrent validity of Sit-to-stand measurement by the CV system compared to physiotherapy measurement. 1 minute
Secondary Standing posture spinal kyphosis Posture as measured by spinal kyphosis 1 minute
Secondary Standing posture tragus to ear Posture as measured by tragus to walk 1 minute
Secondary Leg strength 5 time sit to stand 1 minute
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