NCT04311216

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 22, 2024

Completed
Last Updated

July 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

March 11, 2020

Results QC Date

February 6, 2024

Last Update Submit

February 6, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Kinetics

    On admission

  • Surface Electromyography

    On admission

Study Arms (2)

Shoulder instability participants

Participants with previous a previous episode(s) of shoulder instability

Other: 3D movement analysis with surface electromyography

Age matched controls (no instability)

Participants with no previous a previous episode(s) of shoulder instability

Other: 3D movement analysis with surface electromyography

Interventions

Single measurement session of 3D movement analysis with surface electromyography for upper limb movements

Age matched controls (no instability)Shoulder instability participants

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, SY10 7AG, United Kingdom

Location

MeSH Terms

Conditions

Shoulder InjuriesPrecursor Cell Lymphoblastic Leukemia-LymphomaShoulder DislocationJoint Instability

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesJoint DislocationsJoint DiseasesMusculoskeletal Diseases

Results Point of Contact

Title
Dr Fraser Philp
Organization
University of Liverpool

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 17, 2020

Study Start

February 1, 2021

Primary Completion

August 8, 2023

Study Completion

August 8, 2023

Last Updated

July 22, 2024

Results First Posted

July 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

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.

Locations