Clinical Examination of the ShoulderAIMENCT07147478
Video Analysis and Artificial Intelligence for the Analysis of Upper Limb Movement in Children
An observational study of Clinical Examination of the Shoulder and Video-assisted Clinical Examination, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The principle of the study is to compare the data obtained using a shoulder movement analysis software with those obtained during a traditional clinical examination, that is, using a goniometer and the modified Mallet classification Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Examination of the Shoulder, Video-assisted Clinical Examination
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children from the orthopedic and trauma consultation or the orthopedic hospitalization department, aged 6 to 17, without any upper limb disorders.
Who may be able to join
- Age between 6 and 17 years old at the time of inclusion
- No neurological pathology
- No history of upper limb surgery
- No upper limb trauma above the hand in the 6 months preceding the examination
- Ability to stand for a minimum of 2 minutes
- Consent from the child, both parents, and/or legal representatives for participation in a filmed clinical examination.
Who cannot join
- Inability to understand the different movements requested.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Estelle ALONSO, Intern contact
France1 site
Service de Chirurgie Orthopédique et Réparatrice de l'Enfant - Hôpital Armand Trousseau
Paris, 75012
Manon BACHY-RAZZOUK, MCU-PH, 00 33 1 44 73 69 37, manon.bachy@aphp.fr
Estelle ALONSO, Intern, Estelle.alonso@aphp.fr
About this study
Official title: Video Analysis and Artificial Intelligence for the Analysis of Upper Limb Movement in Children. Validation of a Technique in a Pediatric Population Aged 6 to 17 Years
The principle of the study is to compare the data obtained using a shoulder movement analysis software with those obtained during a traditional clinical examination, that is, using a goniometer and the modified Mallet classification
Read the detailed description
The children are recorded performing 3 sets of shoulder movements (abduction, adduction, flexion, extension, external rotation 1, external rotation 2, internal rotation 2), first on the left and then on the right, at maximum active range of motion, chosen active range of motion, and maximum passive range of motion. The recordings are made by an RGB-D camera connected to a software (ShoulderLoc from B-com) equipped with artificial intelligence that, after image processing, determines the joint range angle of the shoulder for the given movement. This value is compared to the visual estimation of the examiner and its measurement using a goniometer. The hand-mouth, hand-neck, and internal rotation 1 movements are also performed and compared with the data from the modified Mallet classification.
- Keywords
- Clinical Examination of the Shoulder, Video-assisted clinical examination, Artificial intelligence, ShoulderLoc, Goniometer
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of a video-assisted clinical examination method with commonly used clinical practices
Perform 2 sets of 7 to 10 shoulder movements, both active and passive, measure mobility angles using a goniometer and the Mallet classification, as well as the ShoulderLoc software and its artificial intelligence program. Compare the averages obtained for each movement using both methods and compare them using an intraclass correlation coefficient (ICC).
Measured: 1 day
Secondary outcomes (6)
Measurement of optimal acquisition distances for video quality,
Validate the methodology and protocol for acquiring video movements in children
Measured: 1 day
Exam duration based on age
Validate the methodology and protocol for acquiring video movements in children
Measured: 1 day
Technical difficulties.
Validate the methodology and protocol for acquiring video movements in children
Measured: 1 day
Obtain objective, quantified data on pure and combined shoulder movements
Description of results obtained by video recording a series of successive movements and analyzing them with artificial intelligence that allows for angle calculations.
Measured: 1 day
Compare measurements obtained in active and passive motion for the same movement, through video measurement and manual (goniometer) measurement, to simple visual estimation measurements.
Comparison of the average angles obtained in active and passive motion using different methods, compared to visual assessment.
Measured: 1 day
Study the satisfaction of the contribution of video tools in daily clinical practice
Data collection to assess feasibility in daily clinical practice (subgroup studies concerning equipment usage parameters to propose a protocol adapted to children's age).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Examination of the ShoulderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manon BACHY-RAZZOUK, MCU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147478
- Sponsor's protocol ID
- APHP240471
- Other IDs
- IDRCB 2024-A00896-41
- Acronym
- AIME
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Analysis and Artificial Intelligence for the Analysis of Upper Limb Movement in Children. Validation of a Technique in a Pediatric Population Aged 6 to 17 Years
- ClinicalTrials.gov ID
- NCT07147478
- Acronym / sponsor ID
- AIME / APHP240471
- Keywords
- Clinical Examination of the Shoulder, Video-assisted clinical examination, Artificial intelligence, ShoulderLoc, Goniometer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The principle of the study is to compare the data obtained using a shoulder movement analysis software with those obtained during a traditional clinical examination, that is, using a goniometer and the modified Mallet classification
Detailed description
The children are recorded performing 3 sets of shoulder movements (abduction, adduction, flexion, extension, external rotation 1, external rotation 2, internal rotation 2), first on the left and then on the right, at maximum active range of motion, chosen active range of motion, and maximum passive range of motion. The recordings are made by an RGB-D camera connected to a software (ShoulderLoc from B-com) equipped with artificial intelligence that, after image processing, determines the joint range angle of the shoulder for the given movement. This value is compared to the visual estimation of the examiner and its measurement using a goniometer. The hand-mouth, hand-neck, and internal rotation 1 movements are also performed and compared with the data from the modified Mallet classification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children from the orthopedic and trauma consultation or the orthopedic hospitalization department, aged 6 to 17, without any upper limb disorders.
Key inclusion criteria (6 listed)
- Age between 6 and 17 years old at the time of inclusion
- No neurological pathology
- No history of upper limb surgery
- No upper limb trauma above the hand in the 6 months preceding the examination
- Ability to stand for a minimum of 2 minutes
Key exclusion criteria (1 listed)
- Inability to understand the different movements requested.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of a video-assisted clinical examination method with commonly used clinical practices
Time frame: 1 day
Perform 2 sets of 7 to 10 shoulder movements, both active and passive, measure mobility angles using a goniometer and the Mallet classification, as well as the ShoulderLoc software and its artificial intelligence program. Compare the averages obtained for each movement using both methods and compare them using an intraclass correlation coefficient (ICC).
6 secondary outcomes
Measurement of optimal acquisition distances for video quality,
Time frame: 1 day
Exam duration based on age
Time frame: 1 day
Technical difficulties.
Time frame: 1 day
Obtain objective, quantified data on pure and combined shoulder movements
Time frame: 1 day
Compare measurements obtained in active and passive motion for the same movement, through video measurement and manual (goniometer) measurement, to simple visual estimation measurements.
Time frame: 1 day
Study the satisfaction of the contribution of video tools in daily clinical practice
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Estelle ALONSO, Intern contact
Manon BACHY-RAZZOUK, MCU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Examination of the Shoulder and Video-assisted Clinical Examination, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon BACHY-RAZZOUK, MCU-PH (00 33 1 44 73 69 37, manon.bachy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of a video-assisted clinical examination method with commonly used clinical practices (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.