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| Name | Class |
|---|---|
| University of Liverpool | OTHER |
| University of Aberdeen | OTHER |
| Bournemouth University | OTHER |
| Keele University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shoulder instability participants | Participants with previous a previous episode(s) of shoulder instability |
| |
| Age matched controls (no instability) | Participants with no previous a previous episode(s) of shoulder instability |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D movement analysis with surface electromyography | Other | Single measurement session of 3D movement analysis with surface electromyography for upper limb movements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Shoulder Instability Episodes (Subluxation and Dislocations) | Number of shoulder instability episodes (subluxation and dislocations) | One year |
| Kinematics | Kinematic variables related to the movement tasks - Flexion | On admission |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetics | Kinetic variables related to the movement tasks | On admission |
| Surface Electromyography | Muscle activity patterns related to the movement tasks |
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Inclusion Criteria:
Shoulder instability participants
Age matched controls
- Children aged between 8 to 18 years of age
Exclusion Criteria:
Shoulder instability participants
Age matched controls
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust | Oswestry | SY10 7AG | United Kingdom |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Shoulder Instability Participants | Participants with previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements |
| FG001 | Age Matched Controls (no Instability) | Participants with no previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Shoulder Instability Participants | Participants with previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements |
| BG001 | Age Matched Controls (no Instability) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Shoulder Instability Episodes (Subluxation and Dislocations) | Number of shoulder instability episodes (subluxation and dislocations) | Not Posted | One year | Participants | |||||||||||
| Primary | Kinematics | Kinematic variables related to the movement tasks - Flexion | Posted | Mean | 95% Confidence Interval | degrees | On admission |
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Shoulder Instability Participants | Participants with previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Fraser Philp | University of Liverpool | 01517942000 | f.philp@liverpool.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2021 | Feb 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D012783 | Shoulder Dislocation |
| D007593 | Joint Instability |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| OTHER |
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| On admission |
Participants with no previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Kinetics | Kinetic variables related to the movement tasks | Not Posted | On admission | Participants |
| Secondary | Surface Electromyography | Muscle activity patterns related to the movement tasks | Not Posted | On admission | Participants |
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Age Matched Controls (no Instability) | Participants with no previous a previous episode(s) of shoulder instability 3D movement analysis with surface electromyography: Single measurement session of 3D movement analysis with surface electromyography for upper limb movements | 0 | 15 | 0 | 15 | 0 | 15 |
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| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |