- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04311216
Shoulder Instability in Children: Muscle Activity and Movement
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Fraser D Philp, PhD
- Phone Number: 01782734563
- Email: f.d.philp@keele.ac.uk
Study Contact Backup
- Name: Sarah Jarvis, MSc
- Phone Number: 01691 404532
- Email: sarah.jarvis7@nhs.net
Study Locations
-
-
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Oswestry, United Kingdom, SY10 7AG
- Recruiting
- The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
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Contact:
- Fraser D Philp, PhD
- Phone Number: 017827334563
- Email: f.d.philp@keele.ac.uk
-
Contact:
- Sarah Jarvis, MSc
- Phone Number: 01691404532
- Email: sarah.jarvis7@nhs.net
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Shoulder instability participants
Participants with previous a previous episode(s) of shoulder instability
|
Single measurement session of 3D movement analysis with surface electromyography for upper limb movements
|
Age matched controls (no instability)
Participants with no previous a previous episode(s) of shoulder instability
|
Single measurement session of 3D movement analysis with surface electromyography for upper limb movements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of shoulder instability episodes (subluxation and dislocations)
Time Frame: One year
|
Number of shoulder instability episodes (subluxation and dislocations)
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kinematics
Time Frame: On admission
|
Kinematic variables related to the movement tasks
|
On admission
|
Kinetics
Time Frame: On admission
|
Kinetic variables related to the movement tasks
|
On admission
|
Surface electromyography
Time Frame: On admission
|
Muscle activity patterns related to the movement tasks
|
On admission
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RL1812
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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