Shoulder InjuriesNCT04311216
Shoulder Instability in Children: Muscle Activity and Movement
An observational study of Shoulder Injuries and Musculoskeletal Injury, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Injuries, Musculoskeletal Injury, Pediatric ALL
- What is being tested?
- 3D movement analysis with surface electromyography
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2021to 8 Aug 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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).
Who may be able to join
- Shoulder instability participants
- Children aged between 8 to 18 years of age
- Subjective reports of instability with additionally symptomatic instability in the clinical assessment criteria below
- Symptomatic instability on clinical assessment in at least one direction, confirmed by a positive clinical finding (apprehension, guarding, laxity) during the sulcus, apprehension or anterior and posterior shift load tests.
- All forms of instability including multidirectional instability, atraumatic and traumatic subluxations and dislocations.
- Children presenting with an initial or recurrent episode of instability
Show all 10Show fewer
- Children undergoing current management or rehabilitation for their shoulder at the time of the study
- Patients with surgically managed shoulder instability who have since had a further episode of shoulder instability
- Age matched controls
- Children aged between 8 to 18 years of age
Who cannot join
- Shoulder instability participants
- Children with co-existing neurological pathologies or deficits
- Surgically managed patients who have not had episodes of instability following the intervention
- Age matched controls
- Any previous presentation to a health care professional with a diagnosis of shoulder instability
- Children with a previous shoulder injury within the last 3 months on the arm being assessed that has not resolved
Show all 9Show fewer
- Children with co-existing neurological pathologies or deficits
- Children who have had a previous surgical intervention on the arm being assessed
- Children currently undergoing or awaiting medical management, diagnostic investigations or rehabilitation on the arm being assessed
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, SY10 7AG
About this study
Official title: Shoulder Instability in Children: Understanding Muscle Activity and Movement Pattern Differences
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.
- Conditions
- Shoulder Injuries, Musculoskeletal Injury, Pediatric ALL, Dislocation, Shoulder, Instability, Joint
- Being tested
- 3D movement analysis with surface electromyography
- Medical subject headings
- Shoulder Injuries, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Shoulder Dislocation, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D movement analysis with surface electromyographyOther
Single measurement session of 3D movement analysis with surface electromyography for upper limb movements
| Study group | Role | What they receive |
|---|---|---|
| Shoulder instability participants | Participants with previous a previous episode(s) of shoulder instability Receives: Other: 3D movement analysis with surface electromyography | |
| Age matched controls (no instability) | Participants with no previous a previous episode(s) of shoulder instability Receives: Other: 3D movement analysis with surface electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Shoulder Instability Episodes (Subluxation and Dislocations)
Number of shoulder instability episodes (subluxation and dislocations)
Measured: One year
Kinematics
Kinematic variables related to the movement tasks - Flexion
Measured: On admission
Secondary outcomes (2)
Kinetics
Kinetic variables related to the movement tasks
Measured: On admission
Surface Electromyography
Muscle activity patterns related to the movement tasks
Measured: On admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Feb 2021
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Liverpool, University of Aberdeen, Bournemouth University, Keele University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311216
- Sponsor's protocol ID
- RL1812
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2020
- Last updated
- 22 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Instability in Children: Understanding Muscle Activity and Movement Pattern Differences
- ClinicalTrials.gov ID
- NCT04311216
- Acronym / sponsor ID
- RL1812
- Conditions
- Shoulder Injuries, Musculoskeletal Injury, Pediatric ALL, Dislocation, Shoulder, Instability, Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Collaborators
- University of Liverpool, University of Aberdeen, Bournemouth University, Keele University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Posted 22 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder instability participants | – | Other: 3D movement analysis with surface electromyographyParticipants with previous a previous episode(s) of shoulder instability |
| Age matched controls (no instability) | – | Other: 3D movement analysis with surface electromyographyParticipants with no previous a previous episode(s) of shoulder instability |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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).
Key inclusion criteria (10 listed)
- Shoulder instability participants
- Children aged between 8 to 18 years of age
- Subjective reports of instability with additionally symptomatic instability in the clinical assessment criteria below
- Symptomatic instability on clinical assessment in at least one direction, confirmed by a positive clinical finding (apprehension, guarding, laxity) during the sulcus, apprehension or anterior and posterior shift load tests.
- All forms of instability including multidirectional instability, atraumatic and traumatic subluxations and dislocations.
Key exclusion criteria (9 listed)
- Shoulder instability participants
- Children with co-existing neurological pathologies or deficits
- Surgically managed patients who have not had episodes of instability following the intervention
- Age matched controls
- Any previous presentation to a health care professional with a diagnosis of shoulder instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D movement analysis with surface electromyographySingle measurement session of 3D movement analysis with surface electromyography for upper limb movements | Other | Age matched controls (no instability), Shoulder instability participants |
Primary outcome
Number of Shoulder Instability Episodes (Subluxation and Dislocations)
Time frame: One year
Number of shoulder instability episodes (subluxation and dislocations)
Kinematics
Time frame: On admission
Kinematic variables related to the movement tasks - Flexion
2 secondary outcomes
Kinetics
Time frame: On admission
Surface Electromyography
Time frame: On admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Shoulder Injuries and Musculoskeletal Injury, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
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 10 inclusion and 9 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: finished, as of the sponsor's last update on 22 Jul 2024. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 22 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Shoulder Instability Episodes (Subluxation and Dislocations) (time frame: One year). The study lists 2 primary outcomes in all. 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 22 Jul 2024.