An observational study in Shoulder Injuries, Musculoskeletal Injury and Pediatric ALL, sponsored by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust · Observational
The aim of this study is to identify factors responsible for recurrent shoulder instability in children. Shoulder instability, i.e. complete or partial dislocation of the shoulder joint, is common in children, resulting in pain and disability. Recurrent instability can damage the shoulder joint resulting in the premature development of arthritis.
Rehabilitation approaches are preferred over surgical methods for the growing child e.g. physiotherapy to restore movement and prevent further instability. Existing rehabilitation procedures are based on addressing factors assumed to be responsible for instability e.g. physiotherapists may try to increase shoulder stability by building up the shoulder muscles to compensate for the damaged ligaments. It is evident however that the mechanisms of shoulder instability are not well understood, as failure rates for physiotherapy are high, with 70% - 90% of children continuing to suffer recurrent instability. This is an observational, cross-sectional study of children (aged 8 to 18) presenting with shoulder instability of any origin, traumatic or atraumatic (n=15) and an age-matched sample (n=15) with no history of shoulder problems. Muscle activity and movement pattern differences will be measured using non-invasive 3D motion capture and surface electromyography, to identify factors responsible for instability. Only a single visit to the site will be required (The Orthotic Research \& Locomotor Assessment Unit (ORLAU) based at The Robert Jones \& Agnes Hunt Orthopaedic Hospital NHS Foundation Trust in Oswestry.).
If investigators better understand the mechanisms associated with instability, physiotherapy interventions to reduce dislocations and disability can be better targeted. If specific patterns of activity associated with instability are identified, these could be addressed through personalised and improved exercise prescription and rehabilitation. Additionally, causes of instability for which physiotherapy may not be appropriate may be identified, therefore ensuring patients are referred to the correct service in a timely manner, improving patient outcomes and allocating physiotherapy resources more appropriately. Participants will be recruited from musculoskeletal/orthopaedic outpatient clinics. This study is funded by the Private Physiotherapy Education Foundation.
105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.
This study's enrollment of 30 is below the median of 86 across 28 observational studies indexed under Shoulder Dislocation.
Browse Shoulder Dislocation studies →Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust is the lead sponsor of 36 studies on the registry; 16 are open to participants now.
Compared within Shoulder Dislocation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Shoulder Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
This study will consist children aged between eight and 18 years of age. The two groups will include children with (shoulder instability participants) and without shoulder instability (age matched contols).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Shoulder instability participants
Age matched controls
Exclusion Criteria:
Shoulder instability participants
Age matched controls
Participants with previous a previous episode(s) of shoulder instability
Other: 3D movement analysis with surface electromyography
Participants with no previous a previous episode(s) of shoulder instability
Other: 3D movement analysis with surface electromyography
Single measurement session of 3D movement analysis with surface electromyography for upper limb movements
Number of Shoulder Instability Episodes (Subluxation and Dislocations)
Number of shoulder instability episodes (subluxation and dislocations)
Time frame: One year
Kinematics
Kinematic variables related to the movement tasks - Flexion
Time frame: On admission
Kinetics
Kinetic variables related to the movement tasks
Time frame: On admission
Surface Electromyography
Muscle activity patterns related to the movement tasks
Time frame: On admission
| Milestone | Shoulder Instability Participants | Age Matched Controls (no Instability) |
|---|---|---|
| Started | 15 | 15 |
| Completed | 13 | 15 |
| Not completed | 2 | 0 |
Number of shoulder instability episodes (subluxation and dislocations)
Results for this outcome have not been posted.
Kinematic variables related to the movement tasks - Flexion
| degrees | Shoulder Instability Participants | Age Matched Controls (no Instability) |
|---|---|---|
| TH elevation plane | 92 (81 to 102) | 94 (86 to 102) |
| TH elevation angle | 133 (122 to 144) | 130 (125 to 134) |
| TH rotation | 100 (87 to 113) | 99 (90 to 108) |
| TS protraction | 25 (21 to 29) | 24 (21 to 27) |
| TS rotation | 39 (37 to 42) | 40 (40 to 44) |
| TS tilt | 29 (23 to 36) | 33 (27 to 38) |
| GHJ elevation plane | 74 (63 to 85) | 74 (66 to 81) |
| GHJ elevation angle | 101 (89 to 112) | 91 (87 to 96) |
| GHJ rotation | 89 (79 to 99) | 100 (92 to 108) |
| ACJ protraction | 32 (25 to 39) | 34 (29 to 39) |
| ACJ rotation | 16 (13 to 20) | 17 (14 to 19) |
| ACJ tilt | 31 (28 to 34) | 32 (28 to 36) |
| SCJ protraction | 25 (20 to 29) | 24 (21 to 27) |
| SCJ elevation | 11 (10 to 12) | 11 (10 to 12) |
Kinetic variables related to the movement tasks
Results for this outcome have not been posted.
Muscle activity patterns related to the movement tasks
Results for this outcome have not been posted.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Shoulder Instability Participants | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age Matched Controls (no Instability) | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | Shoulder Instability Participants | Age Matched Controls (no Instability) | Total |
|---|---|---|---|
| <=18 years | 15 | 15 | 30 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Shoulder Instability Participants | Age Matched Controls (no Instability) | Total |
|---|---|---|---|
| Mean | 13.9 ± 2.9 | 13.3 ± 3.1 | 13.6 ± 3.0 |
| Sex: Female, Male(Participants) | Shoulder Instability Participants | Age Matched Controls (no Instability) | Total |
|---|---|---|---|
| Female | 9 | 7 | 16 |
| Male | 6 | 8 | 14 |
| Race and Ethnicity Not Collected(Participants) | Shoulder Instability Participants | Age Matched Controls (no Instability) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Shoulder Instability Participants | Age Matched Controls (no Instability) | Total |
|---|---|---|---|
| United Kingdom | 15 | 15 | 30 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The anonymised final trial dataset and anonymised 3D movement data files will be stored on the Keele University Data repository where they will be assigned a DOI. The anonymised data will be available subject to an appropriate request for research and academic use.
Ran from Feb 2021 to primary completion in Aug 2023, 30 months.
Results were first posted in Jul 2024, 11 months after primary completion.
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Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust