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Not yet recruiting NCT07147478

Video Analysis and Artificial Intelligence for the Analysis of Upper Limb Movement in Children

Observational Clinical Examination of the Shoulder Video-assisted Clinical Examination

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Clinical Examination of the Shoulder, Video-assisted Clinical Examination. Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Primary outcome measures

  • Comparison of a video-assisted clinical examination method with commonly used clinical practices [Time frame: 1 day]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Inability to understand the different movements requested.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Service de Chirurgie Orthopédique et Réparatrice de l'Enfant - Hôpital Armand Trousseau — Paris

Identifiers

NCT: NCT07147478 · APHP240471 · IDRCB 2024-A00896-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗