Shoulder Instability in Children: Understanding Muscle Activity and Movement Pattern Differences
Conditions: Shoulder Injuries, Musculoskeletal Injury, Pediatric ALL, Dislocation, Shoulder, Instability, Joint
Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

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FULL/LONG TITLE OF THE STUDY 
Shoulder instability in children: understanding muscle activity and 
movement pattern differences 
 
 
 
 
 
 
SHORT STUDY TITLE / ACRONYM 
Shoulder instability in children: muscle activity and movement 
 
 
 
 
Sponsor Number: RL1812 
 
PROTOCOL VERSION NUMBER AND DATE 
Version 2.0 – 31st July 2021 
 
 

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This protocol has regard for the HRA guidance and order of content 
 
RESEARCH REFERENCE NUMBERS 
 
IRAS Number: 271729 
 
 
Clinical trials.gov Number: NCT04311216 
 
Sponsor Number: RL1812 
 
 
Funder’s Number: 321 
 
 

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SIGNATURE PAGE 
For Robert Jones & Agnes Hunt (RJAH) Orthopaedic Hospital NHS Foundation Trust sponsored studies, 
the sponsor will confirm approval of the protocol by signing the IRAS form and therefore a signature on 
the protocol is not required. The sponsor must be notified of all amendments to the protocol, both 
substantial and non-substantial. Review of amendments by the sponsor will act as the confirmation that 
the sponsor confirms approval of the amended protocol. 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the trial in compliance with the approved protocol, GCP guidelines, the 
Sponsor’s SOPs, and other regulatory requirements as amended. 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the clinical investigation without the prior written 
consent of the Sponsor 
I also confirm that I will make the findings of the study publicly available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent account 
of the study will be given; and that any discrepancies from the study as planned in this protocol will be 
explained. 
 
 
Chief Investigator: 
Signature:  
 
...................................................................................................... 
 
Date: ....../....../...... 
Name (please print): 
Dr Fraser Philp 
...................................................................................................... 
 
 
 
Sponsor statement:   
Where RJAH takes on the sponsor role for protocol development oversight, the signing of the IRAS form 
by the sponsor will serve as confirmation of approval of this protocol. 
 
 

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Table of Contents 
LIST OF ABBREVIATIONS ........................................................................................................................................... 6 
KEY STUDY CONTACTS .............................................................................................................................................. 7 
STUDY SUMMARY ..................................................................................................................................................... 9 
STUDY FLOWCHART ................................................................................................................................................10 
1 
BACKGROUND.................................................................................................................................................11 
2 
RATIONALE......................................................................................................................................................12 
3 
OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS ...................................................................................14 
3.1 
Primary objective ....................................................................................................................................14 
3.2 
Secondary Objectives .............................................................................................................................14 
4 
STUDY DESIGN ................................................................................................................................................15 
5 
STUDY SETTING ...............................................................................................................................................15 
6 
ELIGIBILITY CRITERIA .......................................................................................................................................16 
6.1 
Inclusion criteria .....................................................................................................................................16 
6.2 
Exclusion criteria .....................................................................................................................................16 
7 
STUDY PROCEDURES .......................................................................................................................................17 
7.1 
Recruitment ............................................................................................................................................17 
7.1.1 
Patient identification ......................................................................................................................17 
7.1.2 
Screening ........................................................................................................................................18 
7.2 
Consent ...................................................................................................................................................20 
7.3 
Methodology/ Measurement protocol ..................................................................................................21 
7.4 
Instability history ....................................................................................................................................21 
7.5 
Nine point Beighton hypermobility score ..............................................................................................22 
7.6 
Placement of marker clusters, surface electromyography (sEMG)sensors and identification of virtual 
markers ...............................................................................................................................................................23 
7.6.1 
Sequence of events for data collection ..........................................................................................23 
7.6.2 
Bony landmark identification .........................................................................................................23 
7.6.3 
Surface electromyography (sEMG) placement ...............................................................................27 
7.6.4 
Marker cluster placement ..............................................................................................................33 
7.6.5 
Virtual marker identification and static calibration........................................................................35 
7.7 
Movements for data capture .................................................................................................................36 
7.7.1 
Grip Strength ..................................................................................................................................36 
7.7.2 
Physiological movements ...............................................................................................................36 
7.7.3 
Functional tasks ..............................................................................................................................37 
7.7.4 
Movement under load ....................................................................................................................38 

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7.8 
Follow up for recurrent instability ..........................................................................................................39 
7.9 
Withdrawal criteria .................................................................................................................................39 
8 
STATISTICS AND DATA ANALYSIS ....................................................................................................................40 
8.1 
Sample size calculation ...........................................................................................................................40 
8.2 
Planned recruitment rate .......................................................................................................................40 
8.3 
Statistical analysis plan ...........................................................................................................................40 
9 
DATA HANDLING .............................................................................................................................................42 
9.1 
Data collection tools and source document identification ....................................................................42 
9.2 
Data handling and record keeping .........................................................................................................42 
9.3 
Access to Data ........................................................................................................................................43 
9.4 
Data Sharing Agreements .......................................................................................................................44 
9.5 
Archiving .................................................................................................................................................44 
10 
MONITORING & AUDIT ...............................................................................................................................45 
10.1 
Safety Reporting .....................................................................................................................................45 
11 
ETHICAL AND REGULATORY CONSIDERATIONS ..........................................................................................45 
11.1 
Peer review .............................................................................................................................................47 
11.2 
Public and Patient Involvement ..............................................................................................................47 
11.3 
Data protection and patient confidentiality ...........................................................................................49 
11.4 
Financial and other competing interests for the chief investigator, PIs at each site and committee 
members for the overall study management .....................................................................................................50 
11.5 
Indemnity ................................................................................................................................................50 
11.6 
Access to the final trial dataset ..............................................................................................................50 
12 
REFERENCES ................................................................................................................................................51 
13 
APPENDICIES ...............................................................................................................................................53 
13.1 
Appendix 1 - Study management / responsibilities ................................................................................53 
13.2 
Email to RJAH staff ..................................................................................... Error! Bookmark not defined. 
 
 
 

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LIST OF ABBREVIATIONS 
Define all unusual or ‘technical’ terms related to the trial/study*.  Add or delete as appropriate.  
Maintain alphabetical order for ease of reference. 
AE 
Adverse Event 
AR 
Adverse Reaction 
CI 
Chief Investigator 
CRF 
Case Report Form 
GCP 
Good Clinical Practice 
DOI 
Digital Object Identifier 
ICF 
Informed Consent Form 
DMC 
Independent Data Monitoring Committee 
ISF 
Investigator Site File 
ISRCTN 
International Standard Randomised Controlled Trials 
 
Number 
NIMP 
Non-Investigational Medicinal Product 
ORLAU 
Orthotic Research & Locomotor Assessment Unit 
PI 
Principal Investigator 
PIC 
Participant Identification Centre 
PIS 
Participant Information Sheet 
QA 
Quality Assurance 
QC 
Quality Control 
REC 
Research Ethics Committee 
RJAH 
Robert Jones and Agnes Hunt 
SAE 
Serious Adverse Event 
SAR 
Serious Adverse Reaction 
SDV 
Source Data Verification 
SMF* 
Study Master File 
SMG* 
Study Management Group 
SOP 
Standard Operating Procedure  
SSI 
Site Specific Information 
SUSAR 
Suspected Unexpected Serious Adverse Reaction  
TMG* 
Trial Management Group 
TSC 
Trial Steering Committee 
TMF* 
Trial Master File 
 
 

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KEY STUDY CONTACTS 
 
Chief Investigator 
Dr Fraser Philp 
School of Health Sciences 
Thompson Yates Building 
University of Liverpool 
Liverpool 
L69 3GB 
f.philp@liverpool.ac.uk 
 
Principal Investigator 
Sarah Jarvis 
ORLAU 
Robert Jones & Agnes Hunt Orthopaedic Hospital 
Gobowen 
Oswestry 
SY10 7AG 
01691404532 
sarah.jarvis7@nhs.net 
 
Sponsor 
Teresa Jones 
Research ManagerR&D Department 
ARC Building 
Robert Jones & Agnes Hunt Orthopaedic Hospital 
Gobowen 
Oswestry 
SY10 7AG  
01691 404451 
teresa.jones6@nhs.net 
 
Funder(s) 
The Private Physiotherapy Education Foundation 
Minerva House 
Tithe Barn Way Swan Valley 
Northampton 
NN4 9BA 
 
01604 684960 
admin@ppef.org.uk 
 
Key Protocol Contributors 
Prof. Anand Pandyan 
Mackay Building  
Keele University 
Keele 
01782 734252 
a.d.pandyan@keele.ac.uk 
 
Dr. Ed Chadwick 
School of Engineering 
Fraser Noble Building 
University of Aberdeen 
Aberdeen 
01224273840 

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edward.chadwick@abdn.ac.uk 
 
Mr. Robert Freeman; 
ORLAU 
Robert Jones & Agnes Hunt Orthopaedic Hospital 
Gobowen 
Oswestry 
SY10 7AG 
01691404429 
robertfreeman@nhs.uk 
 
 
 
 

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STUDY SUMMARY 
 
Trial/Study* Title 
Shoulder instability in children: understanding muscle activity and 
movement pattern differences 
Internal Ref. Number (or short title) 
Shoulder instability in children: muscle activity and movement 
v2.0 
Trial/Study*  Design 
Cohort observation 
Cross-sectional study 
Trial Intervention (where applicable) 
N/A 
Trial/Study*  Participants 
15 children (aged between 8 and 18) with shoulder instability 
15 age matched controls 
Planned Sample Size 
30 participants 
Treatment duration 
2 hours 30 minutes maximum 
Follow up duration 
12 months 
Planned Trial Period 
24 months 
 
Objectives 
Outcome Measures 
Primary 
 
* 
 
 
 
Secondary 
 
 
 
 
 
* This is not an experimental study and so there is not a single/primary outcome measure. The following outcomes 
will be derived from this study 
For the single movement analysis session: 
• 
Kinematic variables related to the movement tasks, for example 
o 
joint angles (degrees) 
o 
displacement (position, speed and associated derivatives) 
• 
Kinetic variables related to the movement tasks, for example 
o 
forces/ strength (n, kg/force) 
• 
Muscle activity patterns related to the movement tasks, for example 
o 
Surface electromyography (sEMG) (mv) 
For the follow up outcomes: 
• 
Number of recurrent episodes of instability 
 
 

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STUDY FLOWCHART 
 
 
 

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1 
BACKGROUND 
 
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 we do not fully understand the mechanisms of shoulder instability 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 we better understand the mechanisms associated with instability, we can better target physiotherapy 
interventions to reduce dislocations and disability. If we identify specific patterns of activity associated 
with instability, these could be addressed through personalised and improved exercise prescription and 
rehabilitation. Additionally, we may identify causes of instability for which physiotherapy may not be 
appropriate, 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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2 
RATIONALE 
 
Mechanisms of shoulder instability, and the subsequent development of arthritis, are poorly understood 
(Deitch, Mehlman et al. 2003, McFarland, Kim et al. 2003, Barden, Balyk et al. 2005, Barrett 2015). Both 
surgical and nonsurgical interventions are based on a current understanding of the associated 
mechanisms that may include anatomical predisposition (shallow glenoid, lax ligament and capsule), 
weak muscles, or inappropriate muscle coordination (Harryman, Sidles et al. 1992, Cordasco 2000, Inui, 
Sugamoto et al. 2002, Deitch, Mehlman et al. 2003,McFarland, Kim et al. 2003, Barden, Balyk et al. 
2005, Hovelius and Saeboe 2009, Jaggi and Lambert 2010, Jaggi, Noorani et al. 2012, Barrett 2015, 
Longo, van der Linde et al. 2016, Bateman, Jaiswal et al. 2018, Best and Tanaka 
2018). 
 
Rehabilitation approaches are preferred over surgical methods for the growing child, and management 
is therefore aimed at addressing predominant factors associated with these mechanisms e.g. exercises 
to improve co-ordination of the shoulder muscles if the source of instability is dysfunctional muscle 
control. However, failure rates are high (approximately 70% - 90%), indicating that current understanding 
of these mechanisms is limited. 
 
In children, this can have detrimental long-term effects. This research is important as shoulder instability, 
mainly subluxation and dislocation, is common (23.9/100,000 person years but can be as high as 164.4 
for 14 -16 year olds) (Leroux, Ogilvie-Harris et al. 2015) resulting in pain, decreased movement and 
functional limitations. Diagnosis of shoulder instability is normally delayed (on average by 2-years) and 
70% of children have repeated dislocations (Longo, van der Linde et al. 2016), often associated with 
premature glenohumeral arthropathy (odds ratio 19.3) (Marx, McCarty et al. 2002, Deitch, Mehlman et 
al. 2003).  
 
Shoulder stability results from complex mechanisms comprising finely balanced forces in ligaments, 
muscles and joint surfaces. These can be disrupted in a range of neuromuscular disorders and joint 
degradation, and are vulnerable to traumatic injury. Currently, we are unable to capture this complexity 
to quantify instability during dynamic upper limb tasks performed during clinical assessment and 
rehabilitation (Marchi, Blana et al. 2014). Biomechanical or mathematical modelling of this complex 
structure can help to understand the mechanisms associated with instability and predict outcomes for 
surgical and non-surgical interventions. Loading on internal structures that cannot be measured can 
also be estimated by this approach. Furthermore, approximately 30% of patients who have surgical 
stabilisation of their shoulder go on to sustain further episodes of instability (Deitch, Mehlman et al. 
2003). 
 

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This project is therefore a fundamental step, in the development of biomechanical models which can 
ultimately be used to further our understanding of the shoulder, specifically behaviour of the articulating 
bony surfaces and muscle forces. 
 
 

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3 
OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS 
3.1 
Primary objective 
• 
The primary objective of this study is to identify factors responsible for recurrent shoulder 
instability in children. 
 In order to meet the main objective of this study, a series of secondary objectives need to be met. 
 
3.2 
Secondary Objectives 
The secondary research objectives used to address the main aim of the study are: 
• 
Validation of a 3D movement analysis protocol for measuring upper limb function in children 
with shoulder instability. 
• 
Obtain new data on muscle activity and movement patterns of children with and without 
shoulder instability 
• 
Categorising clinical presentations of instability and identification of important factors for 
recurrent instability 
This is not an experimental study and so there is not a single/primary outcome measure. The following 
outcomes will be derived from this study 
 
For the single movement analysis session: 
• 
Kinematic variables related to the movement tasks, for example 
o joint angles (degrees) 
o displacement (position, speed and associated derivatives) 
• 
Kinetic variables related to the movement tasks, for example 
o forces/ strength (n, kg/force) 
• 
Muscle activity patterns related to the movement tasks, for example 
o Surface electromyography (sEMG) (mv) 
  
For the follow up outcomes: 
• 
Number of recurrent episodes of instability 
 

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4 
STUDY DESIGN 
 
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 (ORLAU, RJAH). No interventions or treatments 
are included in this study as this is an observational, cross-sectional study. 
 
5 
STUDY SETTING 
The research site is located at the RJAH Orthopaedic Hospital NHS Foundation Trust in Oswestry, SY10 
7AG. 
 
The movement analysis sessions will take place at the Orthotic Research & Locomotor Assessment 
Unit (ORLAU) based at RJAH Orthopaedic Hospital NHS Foundation Trust in Oswestry. 
 
Our main recruitment site is based at RJAH, Shropshire, SY10 7AG. Potential participants on their 
routine hospital or health service visits, who fit the inclusion/exclusion criteria, will be given brief 
information about the study by their treating physician/surgeon/therapist. If potential participants express 
an interest in the study the treating physician/surgeon/therapist may also pass on the relevant contact 
details to the study team. Risk mitigation against under recruitment will be achieved by recruiting from 
a further patient identification centre sites Shrewsbury and Telford NHS TRUST, UHNM, Stoke and 
other relevant health care services such as GP practices and additional outpatient services in the 
second. We will also disseminate information about the study using social media. 
 
 
 
 

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6 
ELIGIBILITY CRITERIA 
6.1 
Children with shoulder instability 
6.1.1 Inclusion criteria 
• 
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. 
6.1.2 Exclusion criteria 
• 
Children with co-existing neurological pathologies or deficits 
• 
Surgically managed patients who have not had episodes of instability following the intervention. 
 
6.2 
Age matched control group 
6.2.1 Inclusion criteria 
• 
Children aged between 8 to 18 years of age  
6.2.2 Exclusion criteria 
• 
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  
 
 

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7 
STUDY PROCEDURES 
7.1 
Recruitment 
Our main recruitment site is based at RJAH outpatient clinics, Shropshire. Potential participants on their 
routine hospital visits, who fit the inclusion/exclusion criteria, will be given brief information about the 
study by their treating physician/surgeon/therapist. The study will additionally be advertised in clinical 
centres in the West Midlands such as specialist clinics, GP services and primary care settings, where 
practitioners will signpost potential participants to the primary organisation. If potential participants 
express an interest in the study the treating physician/surgeon/therapist may also pass on the relevant 
contact details to the study team. Posters with information regarding the study will also be located in the 
respective departments. We will also advertise the study and raise awareness of the study through 
social media using an electronic version of the poster advertisement.  
 
Children without shoulder instability will be recruited by contacting staff within the hospital using the 
RJAH staff mailing list using the email included with this submission. 
 
Investigation of referral patterns with clinical collaborators (ORLAU, RJAH, Oswestry) demonstrates that 
clinical recruitment is realistic and achievable. There are approximately 2 referrals a month for children 
with instability who meet our inclusion criteria. 
7.1.1 Patient identification 
Potential participants who meet the inclusion/exclusion criteria will be signposted to our study by their 
treating clinician or through our poster during their routine hospital visit. 
 
 
 

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7.1.2 Screening for children with shoulder instability 
 
Area’s in highlighted in grey must have a positive response to be eligible for the study.  
 
CRITERIA 
YES 
NO 
CHECK 
1. 
A minimum of 12 weeks since last shoulder instability episode 
 
 
 
2. 
Aged between 8 to 18 years 
 
 
 
3. 
3a. Initial episode of shoulder instability OR 
 
 
 
3b. Recurrent episode of shoulder instability 
 
 
4. 
Subjective report of instability  
 
 
* 
5. 
Symptomatic instability in at least 
one direction, confirmed by a 
positive clinical finding of  
- 
Apprehension 
- 
Guarding 
- 
Laxity  
5a. Sulcus (inferior) 
 
 
 
5b. Anterior shift load 
 
 
5c. Posterior shift load 
 
 
5d. Apprehension relocation 
 
 
6. 
Currently undergoing rehabilitation  
 
 
 
7. 
Shoulder instability episode following surgical management of 
shoulder instability 
 
 
 
8. 
No co-existing neurological pathologies or additional 
musculoskeletal injuries to the upper limb being assessed 
 
 
 
*if yes must have a positive response to question 5. 
 
 

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7.1.3 Screening for age matched controls 
 
All screening questions must have a positive response to be eligible for the study 
 
CRITERIA 
YES 
NO 
CHECK 
1. 
Aged between 8 to 18 years 
 
 
 
2. 
NO previous presentation to a health care professional with a 
diagnosis of shoulder instability 
 
 
 
4. 
NO history of shoulder injury within the last 3 months on the arm 
being assessed 
 
 
 
5. 
NO co-existing neurological pathologies or deficits 
 
 
 
6. 
NO previous surgical intervention on the arm being assessed 
 
 
 
7. 
NOT currently undergoing or awaiting medical management, 
diagnostic investigations or rehabilitation on the arm being 
assessed 
 
 
 
 
7.1.4 Shoulder stability tests for age matched controls (not for screening) 
 
CRITERIA 
YES 
NO 
Type e.g. (L) 
1. 
Please make note of any 
clinical findings of  
- 
Apprehension (A) 
- 
Guarding (G) 
- 
Laxity (L) 
1a. Sulcus (inferior) 
 
 
 
1b. Anterior shift load 
 
 
 
1c. Posterior shift load 
 
 
 
1d. Apprehension relocation 
 
 
 
 
 

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7.2 
Consent 
 
Three different consent/assent forms have been developed. 
 
For participants below 9 years old, very simple language was used with two tick boxes that indicate 
acceptance (smiley face) or decline (frowning face) to demonstrate feelings about taking part instead of 
initial boxes. This document's readability level was also checked with two children (7 and 8 years old), who 
found it understandable. 
 
For ages between 9-15, their assent form contains simple questions with simple YES or NO answer instead 
of initial boxes. This document's readability level was checked by a Public Involvement and Engagement 
group (CRN West Midlands) and different children of appropriate age groups. 
 
Those above 16 years and parent/guardians, their consent form language level was checked with two teens 
(18 and 17 years old). 
 
Once participants and their parents/guardians have expressed an interest in the study, the researcher will 
spend time discussing the research with participant and parents/guardians to ensure that all of their 
questions and concerns are addressed. 
 
During the visit, the participants and their parent/guardian will be provided with an additional opportunity to 
ask questions. Once that is completed, the researcher will provide the consent form to parents/guardians, 
and will explain the purpose of the appropriate assent/consent form. Participants will fill out the assent form 
with the presence of parents/guardians and the researcher.  
 
All developed forms language level was done using Microsoft Word Flesch-Kincaid tool to ensure that they 
meet the language level of their target participants. 
 
 

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7.3 
Methodology/ Measurement protocol 
Following the consent/assent process the following methodology/ protocol will be used to collect the 
data required for meeting the study objectives. For children with shoulder instability, the affected arm 
will be measured. For children with no instability the dominant hand will be measured. 
 
7.4 
Instability history 
For participants identified as being eligible ONLY, the follow up questions below should be asked 
 
FOLLOW UP QUESTIONS 
RESPONSE 
F1. 
Time since last episode of instability 
 
 
Side of instability 
LEFT 
RIGHT 
Dominant hand 
LEFT 
RIGHT 
F2. 
Most recent episode of instability 
Partial (subluxation) 
 
Full (dislocation)  
 
Reported direction of instability 
Anterior 
YES 
NO 
Posterior 
YES 
NO 
Multi-directional 
YES 
NO 
Previous instability episode types 
Partial (subluxation) 
 
 
Full (dislocation)  
 
 
Number of instability episodes 
Partial (subluxation) 
 
 
Full (dislocation) 
 
 
 
 
 

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7.5 
Nine point Beighton hypermobility score 
One point is given for each of the side and test 
 
TEST DESCRIPTION 
 
SCORE 
B1. 
Passively extend the fifth metacarpophalangeal joint ≥ 90⁰ 
L 
 
R 
 
B2. 
Passively oppose the thumb to the anterior aspect of the forearm  
L 
 
R 
 
B3. 
Passively hyperextend the elbow to  ≥ 10⁰ 
L 
 
R 
 
B4. 
Passively hyperextend the knee to  ≥ 10⁰ 
L 
 
R 
 
B5. 
Actively place hands flat on the floor without bending the knees 
L 
 
R 
 
Total 
/9 
 
 
 

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7.6 
Placement of marker clusters, surface electromyography (sEMG)sensors and 
identification of virtual markers 
7.6.1 Sequence of events for data collection 
i. 
Bony landmark identification and mark up 
ii. 
sEMG placement identification and mark up 
iii. 
Skin preparation for sEMG 
iv. 
sEMG placement 
v. 
sEMG testing (recorded) 
vi. 
Marker cluster placement 
vii. 
Marking of cluster positions 
viii. 
Identification of virtual markers using pointer and static calibration (recorded) 
ix. 
Securing of required marker clusters and sEMG 
7.6.2 Bony landmark identification 
The following bony landmarks will be palpated and marked for identification with the pointer following 
marker cluster and sEMG placement. 
 
For consistency of bony landmark identification and marking participant should be seated with their 
hands resting on their lap. 
Head position must be neutral i.e. no large degrees of flexion/extension 
 
 

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Location illustration 
Description of identification of illustration 
 
 
 
 
THORAX SEGMENT 
 
 
1. C7 Spinous Process (C7) 
- 
C7 can be seen with flexion of the head and protrudes more 
dorsally than C6 and T1. With extension of the head C6 
disappears first and C7 remains palpable for longer. 
 
2. T8 Spinous Process (T8) 
- 
From either the proximal or distal reference points (below) 
Alternate with two palpating fingers and count from cranial to 
caudal to the 8th thoracic vertebrae 
 
Reference points: 
- 
T3 / T4 spinous process in line with spina scapulae 
- 
T7 spinous process in line with angulus inferior scapula 
 
3. Insicura Jungularis (IJ) 
- 
Manubrium sterni is proximally bounded by the incisura 
jungularis. Cranial bowl-shaped limitation of the manubrium 
sterni (deepest point). Palpation/ identification of the point 
should be done from superior to inferior. 
 
4. Processus Xiphoideus (PX) 
- 
Most caudal point of the sternum in keeping with the midline. 
 
 
CLAVICLE SEGMENT 
 
5. Art. Sternoclavicularis (SC) 
- 
Located bilaterally from the IJ, course from cranio-medial to 
caudo-lateral. (protraction and retraction of the shoulder 
facilitate palpation) 
 
6. Art. Acromioclavicularis (AC) 
- 
Front: follow the front of the acromion to medial until a discrete 
notch is felt (V-shaped to open anterior). 
- 
Back: follow the top of the spina scapula and the back of the 
clavicle laterally to where the two bone pieces meet. A little 
further to the lateral side is the dorsal boundary of the AC joint. 
 
 
 

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SCAPULA SEGMENT 
 
7. Processus Coracoideus (PC) 
- 
In the fossa infraclavicularis (ventral) from medial to lateral 
palpation until one feels a medial, bony structure (only the top 
and medial side can be palpated). See CLAVICLE SEGMENT 
- 
Palpation of the PC may be facilitated by protracting the 
shoulder girdle 
 
8. Trigonum Scapulae (TS) 
- 
Origin of the spina scapulae in line with the spinous process 
of T3 on the medial scapula edge. (spina goes to the latero-
cranial). Palpate the midpoint of the triangular surface on the 
medial border of the scapula in line with the scapular spine 
 
9. Angulus Inferior (AI) 
- 
Follow the medial edge of the scapula caudally (most caudal 
point of the scapula, location at the level of the spinous 
process of T7) 
 
10. Angulus Acromialis (AA) 
- 
Follow the spina scapulae, from mid-caudal to latero-cranial 
until kink is felt in the dorso-lateral edge of the acromion (this 
rear corner is rectangular). Most laterodorsal point of the 
scapula 
 
 
HUMERUS SEGMENT 
 
11. Glenohumeral rotation centre (GH) 
- 
Calculated via regression – with the participant’s arm in 
abduction ask them to rotate their arm in a circular motion. 
 
Forearm in supinated position 
 
12. Lateral Epicondyle (LE) 
- 
Palpable on the distal lateral side of the humerus (slight 
passive flexion of the elbow facilitates palpation). 
 
13. Medial Epicondyle (ME) 
- 
Palpable on the distal medial side of the humerus (slight 
passive flexion elbow). 
 
 

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FOREARM SEGMENT 
 
Forearm in prone position – palpation should be done from distal to 
proximal 
 
14. Radial Styloid (RS) 
- 
Most caudal-antero point on the radial styloid 
- 
Lateral edge of the radius leads distally into a depression. 
Palpate slightly proximal to the depression and the radial 
styloid is the palpable protrusion. Palpation easiest with radial 
deviation. 
 
15. Ulnar Styloid (US) 
- 
Most caudal-postero point on the ulnar styloid. Medial edge of 
the ulna leads distally into a depression. Palpate slightly 
proximal to the depression and the ulna styloid is the palpable 
protrusion. Palpation easiest with ulna deviation. 
 
HAND SEGMENT 
 
16. Styloid process of 3rd Metacarpal (MC3) 
- 
Follow the third metacarpal on its dorsal side from distal to 
proximal. The small bone elevation on the base is the styloid 
process. Palpation easiest with maximum palmar flexion. (os 
capitatum lies in depression just proximal to styloid process of 
the 3rd Metacarpal) 
 
17. Distal head of 2nd Metacarpophalangeal joint (MCP2) 
- 
Palpate just distal to the 2nd metacarpophalangeal joint (these 
joints are easy to palpate on the dorso-lateral side in light 
flexion position or with longitudinal traction). 
 
18. Distal head of 3rd Metacarpophalangeal joint (MCP3) 
- 
Palpate just distal to the 3rd metacarpophalangeal joint (these 
joints are easy to palpate on the dorso-lateral side in light 
flexion position or with longitudinal traction). 
 
19. Distal head of 5th Metacarpophalangeal joint (MCP5) 
- 
Palpate just distal to the 5th metacarpophalangeal joint (these 
joints are easy to palpate on the dorso-lateral side in light 
flexion position or with longitudinal traction). 
 
 
 
 

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7.6.3 Surface electromyography (sEMG) placement 
Muscle bellies will be identified and marked during the clinical examination.  Skin preparation is required, 
using a conductive and slightly abrasive gel.  Subjects with lots of body hair may need to have small patches 
of skin shaved at the site of the sensors.  Small wireless sensors are placed over each muscle belly.  These 
are held in place using a combination of double sided tape and elasticated bandage. 
 
The location of the bipolar sensor is always described as a point on a line between two anatomical 
landmarks. Where available electrode placement has been adapted from SENIAM guidelines or for cases 
Criswell et al 2010 
 
Placement illustration 
sEMG electrode Placement 
 
 
 
1. Middle Trapezius (listed on SENIAM as Upper) 
 
Location: The electrodes need to be placed at 50% on the line from 
the acromion to the spine on vertebra C7 
 
Orientation: In the direction of the line between the acromion and the 
spine on vertebra C7 
 
Clinical test: Elevate the acromial end of the clavicle and scapula; 
extend and rotate the head and neck toward the elevated shoulder 
with the face rotated in the opposite direction. Apply pressure 
against the shoulder in the direction of depression and against the 
head in the direction of flexion anterolateral. 
 
With hand resting by side 
Prompts to participants for testing: “Shrug your shoulder up” 
 
Guidelines: SENIAM 
 
 

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Source: Copyright © Clinical Resources, Inc. 
2. Infraspinatus 
 
Location: Palpate the spine of the scapula. Electrode placed parallel 
to and approximately 4 cm below the spine of the scapula, on the 
lateral aspect, over the infrascapular fossa of the scapula. Avoid 
placement over the posterior deltoid 
 
Orientation: Parallel with the spine of the scapula. 
 
Clinical test: Elbow bent to 90 degrees with lateral (external) rotation 
of the bent arm out to the side; abduction of the arm. Apply pressure 
to resist external rotation and abduction of the arm.  
 
With their arm out to the side with elbow flexed 
Prompts to participants for testing: “Push your arm out towards 
me” 
 
Guidelines: Criswell et al 2010 
 
 
Source: Copyright © Clinical Resources, Inc. 
3. Triceps Brachii 
 
Location: Electrodes need to be placed at 50 % on the line between 
the posterior crista of the acromion and the olecranon. 
 
In some cases, the size of the participant’s triceps relative to the 
sEMG electrode may not be sufficient to differentiate the heads of 
triceps. Therefore, a more central positioning may be used as a 
pragmatic approach to managing this and the cluster. 
 
Orientation: In the direction of the line between the posterior crista 
of the acromion and the olecranon. 
 
Clinical test: Extend the elbow while applying pressure to the 
forearm in the direction of flexion. 
 
With their elbow bent 
Prompts to participants for testing: “Straighten your elbow” 
 
Guidelines: Criswell et al 2010 
 
 

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Source: Copyright © Clinical Resources, Inc. 
4. Latissimus Dorsi 
 
Location: Palpate the scapula. Electrodes is placed approximately 4 
cm below the inferior tip of the scapula, half the distance between 
the spine and the lateral edge of the torso. They are  
 
Orientation: Parallel to the fibres of Latissimus Dorsi which are 
oriented in a slightly oblique angle of approximately 25 degrees 
 
With a cupped hand, supporting a flexed elbow 
Prompts to participants for testing: “Push down and back in a 
rowing motion” 
 
Clinical test: Extend, adduct, or medially rotate the arm. Participant 
to start arm externally rotated and in some forward flexion. Apply 
pressure to resist extension, adduction and medial rotation of the 
arm.  
 
Guidelines: Criswell et al 2010 
 
5. Posterior deltoid 
 
Location: Centre the electrodes in the area about two finger breaths 
behind the angle of the acromion 
 
Orientation: In the direction of the line between the acromion and the 
little finger. 
 
Clinical test: Abduct the shoulder in slight extension, with the 
humerus in slight medial rotation. The humerus is placed in slight 
medial rotation in order to offload the posterior fibres. The 
anatomical action entails slight lateral rotation while pressure is 
applied against the posterolateral surface of the arm, above the 
elbow in the direction of adduction and slight flexion. 
 
With their elbow flexed 
Prompts to participants for testing: “Pull your arm back” 
 
Guidelines: SENIAM 

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6. Anterior deltoid 
 
Location: one finger width distal and anterior to the acromion 
 
Orientation: In the direction of the line between the acromion and the 
thumb 
 
Clinical test: Shoulder abduction in slight flexion, with the humerus 
in slight rotation. In the erect sitting position, it is necessary to place 
the humerus in slight lateral rotation to increase the load on the 
anterior fibres. The anatomical action of the anterior deltoid entails 
slight medial rotation while pressure is applied against the antero 
medial surface of the arm in the direction of adduction and slight 
extension. 
 
With their elbow flexed 
Prompts to participants for testing: “Push your arm forwards” 
 
Guidelines: SENIAM 
 
Source: Copyright © Clinical Resources, Inc. 
7. Pectoralis Major (clavicular head) 
 
Location: For clavicular placement, palpate the clavicle. Electrode is 
placed on the chest wall at an oblique angle toward the clavicle, 
approximately 2 cm below the clavicle, just medial to the axillary fold 
 
Orientation: at an oblique angle toward the clavicle 
 
Clinical test: Flexion of the arm, abduction of the arm above 90 
degrees, medial rotation, and horizontal adduction of arm. 
 
With their elbow flexed to 90⁰ and arm abducted and flexed 
Prompts to participants for testing: “Push forwards out and in 
front of you” 
 
Guidelines: Criswell et al 2010 
 
 

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8. Biceps Brachii 
 
Location: Electrodes need to be placed on the line between the 
medial acromion and the fossa cubit at 1/3 from the fossa cubit. 
 
Orientation: In the direction of the line between the acromion and the 
fossa cubit 
 
Clinical test: Place one hand under the elbow to cushion it from table 
pressure and flex the elbow slightly below or at a right angle, with 
the forearm in supination. Press against the forearm in the direction 
of extension. 
 
With their elbow flexed to 90⁰  
Prompts to participants for testing: “Bend your elbow” 
 
Guidelines: SENIAM 
 
Source: Copyright © Clinical Resources, Inc. 
9. Common Flexor Origin 
 
Location: About 3-5 centimetres from the elbow joint at distal 
ventral aspect of forearm.  Assessor would ask subject to flex 
elbow to palpate flexors bulk. 
 
Orientation: with the electrodes oriented in the direction of the 
muscle fibres which run longitudinally down the forearm. 
 
Clinical test: Flexion of the wrist  
 
Prompts to participants for testing: “Bend your wrist down” 
 
Guidelines: Criswell et al 2010 

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Source: Copyright © Clinical Resources, Inc. 
10. Common Extensor Origin 
 
Location: About 3-5 centimetres from the elbow joint at proximal 
dorsal aspect of forearm.  Assessor would ask subject to extend 
elbow and wrist, to palpate extensors bulk. Electrode is placed in the 
centre of the muscle bulk. 
 
Orientation: with the electrodes oriented in the direction of the 
muscle fibres which run longitudinally down the forearm. 
 
Clinical test: Extension of the wrist 
 
Prompts to participants for testing: “Bend your wrist up” 
 
Guidelines: Criswell et al 2010 
 
 

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7.6.4 Marker cluster placement 
 
Each segment is defined using a minimum of 3 cluster based markers which are not collinear. A range 
of marker clusters (marker diameter 14mm) will be used depending on the anthropometric 
characteristics of the participant e.g. size, arm length and width in addition to ensuring adequate visibility 
of markers. A description of the marker cluster placement has been described below and has been 
adapted from Jaspers et al 2011. 
 
As a quality control measure, the borders of all clusters will be marked to ensure no movement has 
occurred. 
 
Placement illustration 
Description of placement 
 
 
 
 
1. Sternal marker cluster 
 
Positioned using double sided tape on the anterior aspect of the 
thorax, approximately one finger width below the sternal notch. 
Placement must be below the sterno-clavicular joint and in keeping 
with the midline of the body. The antero-superior border of the thorax 
is defined by the insicura jugularis (IJ) point and the antero-inferior 
border is defined Processes Xiphoideus (PX) point. 
 
For participants with breast tissue, a more superior placement of the 
sternal cluster may be required, not exceeding the antero-superior 
border of the thorax. In this case, adequate visibility of the marker 
cluster should be ensured prior to identification of virtual markers. 
 
Mark the inferior edge of the cluster. 
 
 
 
2. Acromion marker cluster 
 
Positioned using double sided tape on the flat surface of the 
acromion. Secure to the acromion with extra tape.  
 
Following identification of the acromioclavicular joint, palpate 
posteriorly to identify the flattest area of the acromion. 
 
Mark the base of the cluster. 
 
 

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3. Humeral marker cluster 
 
Positioned using velcro on the distal aspect of the humeral segment. 
As a general guide the inferior component of the marker cluster 
should be proximal to and in line with the lateral epicondyle (LE) of 
the humerus. 
 
Mark the inferior edge of the cluster. 
 
 
 
4. Forearm marker cluster 
 
Positioned using velcro on the postero-distal aspect of the forearm 
segment. 
As a general guide the inferior border of the marker cluster should be 
proximal to the radial styloid (RS) and ulnar styloid (US) points. 
 
Mark the inferior edge of the cluster. 
 
 
 
5. Hand marker cluster 
 
Positioned using double sided tape on the dorsal aspect of the hand. 
The marker cluster should be placed distal to the 3rd carpometacarpal 
joint and distal to all row of metacarpophalangeal joints. 
 
The cluster is shaped like a V and the centre of the cluster should 
align with the 3rd metacarpal head. 
 
Mark the inferior edge of the cluster. 
 
 
 

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7.6.5 Virtual marker identification and static calibration 
Following completion of the sEMG placement, the virtual markers will be identified using a pointer. This 
requires placement of the pointer tip on the bony landmarks outline in section 7.6.2. This is completed 
with the participant in sitting with their hand on their knee. The virtual markers and movements required 
for calibration are: 
No. 
Name 
Abbreviation 
Checklist 
1.  
C7 Spinous Process 
C7 
 
2.  
T8 Spinous Process 
T8 
 
3.  
Insicura Jungularis -  (Jugular notch) 
IJ 
 
4.  
Processus Xiphoideus -  (Xiphisternum) 
PX 
 
5.  
Art. Sternoclavicularis – (Sternoclavicular joint) 
SC 
 
6.  
Art. Acromioclavicularis - Acromioclavicular joint 
AC 
 
7.  
Processus Coracoideus - Coracoid process 
PC 
 
8.  
Trigonum Scapulae – medial border spine of scapula 
TS 
 
9.  
Angulus Inferior (AI) - inferior angle of the scapula 
AI 
 
10.  
Angulus Acromialis - Latero-inferior edge of scapula spine 
AA 
 
11.  
Glenohumeral rotation center* 
GH 
 
12.  
Lateral epicondyle 
LE 
 
13.  
Medial epicondyle 
ME 
 
14.  
Radial Styloid 
RS 
 
15.  
Ulnar Styloid 
US 
 
16.  
Styloid process of 3rd Metacarpal 
MC3 
 
17.  
Distal head of 2nd Metacarpophalangeal joint 
MCP2 
 
18.  
Distal head of 3rd Metacarpophalangeal joint 
MCP3 
 
19.  
Distal head of 5th Metacarpophalangeal joint 
MCP5 
 
20.  
Hand on knee – static for trial and sEMG** 
HandKnee 
 
* Calculated via regression – with the participant’s arm in abduction ask them to rotate their arm in a 
circular motion. 
** Participant seated with their hand on their 
knee and their contralateral hand holding the 
pointer as per the image. 
 
 

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7.7 
Movements for data capture 
7.7.1 Grip Strength  
Participants will have their grip strength tested using a handheld dynamometer. The total repetitions will 
not exceed 3 for each activity and will be broken up into 3 sets of 1 repetition each side. 
• 
Testing limb 
o affected and unaffected arm [children with instability] 
o left and right/ dominant and non-dominant arm [children without instability] 
• 
Starting position – Participant in standing. Elbow flexed to 90⁰ with hand in thumbs up position 
with handheld dynamometer. 
• 
Movement task – Participants will be instructed to squeeze the handheld dynamometer as hard as 
they comfortably can for no longer than 5 seconds 
7.7.2 Physiological movements 
• 
For Physiological movements and Functional tasks – the total number will not exceed 12 
repetitions for each activity in total and will be broken up into 2 sets of 6 repetitions. 
• 
For the Movements under load – the total number will not exceed 6 repetitions for each activity 
in total and will be broken up into 2 sets of 3 repetitions. 
Before each movement activity, participants will have the required movements demonstrated to them along 
with instructions regarding the start and finish positions. 
 
P1. Flexion  
• 
Testing limb 
o affected arm [children with instability] 
o dominant [children without instability] 
• 
Starting position – Participant in standing. Palmar surface resting on the lateral aspect of their 
thigh (in keeping with the midline of the body in the coronal plane). 
• 
Movement task – Participants will be instructed to lift their arm out in front of them as high as they 
possibly can and then return it to the starting position. 
 
 

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P2. ABDuction 
• 
Testing limb 
o affected arm [children with instability] 
o dominant [children without instability] 
• 
Starting position – Participant in standing. Anatomical position i.e. Lateral aspect of the 
hypothenar eminince resting on the lateral aspect of their thigh (in keeping with the midline of the 
body in the coronal plane).  
• 
Movement task – Participants will be instructed to lift their arm out to their side as high as they 
possibly can and then return it to the starting position. 
P3. Abduction to ≈45⁰ and then lateral rotation 
• 
Testing limb 
o Affected arm [children with instability] 
o dominant [children without instability] 
• 
Starting position – Participant in standing. Elbow flexed to 90⁰ with hand in thumbs up position. 
• 
Movement task – Participants will be instructed to lift their arm out to their side up to ≈45⁰ ⁰ at the 
shoulder. Maintaining the arm in this position, participants will then be asked to laterally rotate their 
shoulder as far as is comfortable for the required or maximally tolerable amount of repetitions. 
Following this, participants will be instructed to then return it to the starting position. 
 
7.7.3 Functional tasks 
 
F1. Hand behind head 
• 
Testing limb 
o affected arm [children with instability] 
o dominant [children without instability] 
• 
Starting position – Participant in standing. Palmar surface resting on the lateral aspect of their 
thigh (in keeping with the midline of the body in the coronal plane). 
• 
Movement task – Participants will be instructed to place their hand on the top of their head and 
then return it to the starting position. 
 
 

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7.7.4 Movement under load 
• 
These will not exceed 6 repetitions for each i.e. 2 sets of 3 repetitions 
Participants will perform the movements outlined below under a loaded condition using a self-selected 
weight. The participants will be provided with a series of weights from which to choose and advised to select 
a weight that allows them to complete the movements comfortably. 
M1. Flexion 
• 
Testing limb 
o affected arm [children with instability] 
o dominant [children without instability] 
• 
Starting position – Participant in standing with weight in hand. Palmar surface facing the lateral 
aspect of their thigh (in keeping with the midline of the body in the coronal plane). 
• 
Movement task – Participants will be instructed to lift their arm out in front of them as high as they 
possibly can and then return it to the starting position. 
M2. Abduction 
• 
Testing limb 
o affected arm [children with instability] 
o dominant [children without instability] 
• 
Starting position – Participant in standing with weight in hand. Anatomical position i.e. Lateral 
aspect of the hypothenar eminince facing the lateral aspect of their thigh (in keeping with the midline 
of the body in the coronal plane). 
• 
Movement task – Participants will be instructed to lift their arm out to their side as high as they 
possibly can and then return it to the starting position. 
M3. Abduction to ≈ 45⁰ ⁰ and then lateral rotation 
• 
Testing limb 
o affected arm [children with instability] 
o dominant [children without instability] 
• 
Starting position – Participant in standing. Elbow flexed to 90⁰ with hand in thumbs up position. 
• 
Movement task – Participants will be instructed to lift their arm out to their side up to ≈45⁰ ⁰ at the 
shoulder. Maintaining the arm in this position, participants will then be asked to laterally rotate their 
shoulder as far as is comfortable for the required or maximally tolerable amount of repetitions. 
Following this, participants will be instructed to then return it to the starting position. 

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7.8 
Follow up for recurrent instability 
Following the movement analysis session, participants will be provided with a diary to record and further 
episodes of instability as per (appendix). Provided with information and guidance on how to complete 
the diary. Participants in both groups will additionally be followed up on a monthly basis via a telephone 
call for up to 12 months to record the number of instability episodes experienced. Monthly follow ups 
have been selected to ensure accurate recording of instability episodes and facilitation of diary 
recordings. 
 
7.9 
Withdrawal criteria 
Participants’ have a right for unrestricted withdrawal at any point of this study. Participants have been 
informed within the information sheet that if they choose to withdraw, identifiable data already collected 
with consent would be retained and used in the study. No further data would be collected or any other 
research procedures carried out on or in relation to the participant. Participants have also been 
instructed that if they wish to withdraw they may do so and no one will mind. 
 
 

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8 
STATISTICS AND DATA ANALYSIS 
8.1 
Sample size calculation 
This is an observational, cross-sectional study. 
• 
A power calculation, used to determine the required sample size, is not possible for this study as 
the standard error of measurement (SEM - essential to identify a minimally clinically important 
difference) is not known. 
• 
This study will provide the data from which SEM can be estimated and this can then be used to 
inform power calculations for future studies. 
• 
Our rationale for selecting a sample size of 15 in each group (30 total) has been based on previous 
work which has developed and then implemented protocols for clinical practice. 
• 
The two references cited below have developed clinical measurement protocols using sample sizes 
of 10 typically developing children and 12 children with cerebral palsy affecting the upper limbs. 
• 
In the absence of an equivalent study in paediatric shoulder instability a sample size of 15/group 
reflects the current research practice in the literature and will be able to provide us with population 
estimates of “standard error of measurement - SEM” in typically developing children and those with 
upper limb pathology. 
 
Jaspers, E., et al., Upper limb kinematics: development and reliability of a clinical protocol for children. Gait 
Posture, 2011. 33(2): p. 279-85. 
Jaspers, E., et al., The reliability of upper limb kinematics in children with hemiplegic cerebral palsy. Gait & 
Posture, 2011. 33(4): p. 568-575. 
 
8.2 
Planned recruitment rate 
Investigation of referral patterns with clinical collaborators prior to covid-19 (ORLAU, RJAH, Oswestry) 
demonstrated that clinical recruitment is realistic and achievable. There are approximately 2 referrals a 
month for children with instability who meet our inclusion criteria. Risk mitigation against under 
recruitment will be achieved by additionally advertising the study in clinical centres in the West Midlands 
such as specialist clinics, GP services and primary care settings, where practitioners will signpost 
potential participants to the primary organisation. Posters with information regarding the study will also 
be located in the respective departments. We will also advertise the study through social media using 
an electronic version of the poster. 
 
8.3 
Statistical analysis plan 
The aim of this study is to identify factors responsible for recurrent shoulder instability in children. To 
meet the main aim, the following objectives, need to be met. The methods of analysis used to meet 
the study objectives have been reported below. 

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The analysis of measurement units will inform the main study objective and secondary objectives. 
 
• 
Kinematic data such as joint angles and displacements – average range of movement values, as 
well as absolute minimum and maximum values will be reported for all functional tasks. For 
comparison purposes, descriptive statistics will be used to report the group behaviours and 
variability including means and standard deviations. 
• 
Kinetics - force/strength – The range of force and strength values, as well as absolute minimum 
and maximum values will be reported for all functional tasks. For comparison purposes, descriptive 
statistics will be used to report the group behaviours and variability 
• 
Muscle activity patterns - muscle activity (absence or presence), timing of muscle onset, 
percentage of maximum contraction and time of peak intensity will be used. This methodology is 
consistent with previously published research and is used for informing clinical decision making 
processes 
 
The secondary research objectives used to address the main aim of the study are: 
1. Validation of a 3D movement analysis protocol for measuring upper limb function in children with 
shoulder instability. 
i) Individual variability (associated with of the measurement units outlined above) will be 
determined using the coefficient of variation for all data. 
ii) The reliability and error associated with the protocol will be determined using the standard 
error of measurement for the measurement units outlined above. The reliability of the 
protocol will be determined through a sensitivity analysis investigating what effect 
perturbation of the virtual markers has on the outputs of the biomechanical model e.g. 
kinematics, position of the humerus 
2. Obtain new data on muscle activity and movement patterns of children with and without shoulder 
instability 
i) The method of analysis outlined above will inform this objective 
3. Categorising clinical presentations of instability and identification of important factors for recurrent 
instability 
i) data from study objective 2 will be evaluated to identify features i.e. movement or muscle 
activity patterns, which may be used to categorise clinical presentations of shoulder 
instability. An appropriate clustering/categorisation method will be selected once the 
characteristics of the dataset has been established 

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if we get a large enough sample size of participants with a homogenous clinical presentation and if 
three or more groups are identified in the preceding work package, an analysis of variance (ANOVA) 
can be used. For less than three groups, an independent sample t-test will be used. 
 
9 
DATA HANDLING 
9.1 
Data collection tools and source document identification 
All documents and information are confidential and will be handled and safeguarded in the manner that 
ensures privacy and confidentiality of participant’s personal information, in compliance with Data 
Protection Act (2018). 
 
All documents and forms containing participants’ personal information will be safeguarded and stored 
on-site at either Robert Jones Angus Hunt Hospital (RJAH) main building or The Orthotic Research & 
Locomotor Assessment Unit (ORLAU) building in RJAH. Only authorised individuals involved in this 
study will have the right to access these documents and information. Any electronic participants’ 
information and/or data will only be stored in an NHS secured laptop, with two-factor authentication 
access. Then, these will be transferred to RJAH hospital servers. Finally, the study team and associated 
institutions will have access to anonymised data only. Only anonymised data will be transferred to an 
encrypted university laptop. 
 
9.2 
Data handling and record keeping 
This data management plan was developed ensure that data of this research is managed and shared 
in a robust and professional manner.  The plan was formulated with adherence  the United Kingdom 
Research and Innovation Data Policy, RJAH Hospital Trust Data Protection, Data Protection Act 2018 
and General Data Protection Regulation 20181.   
 
All forms, documents, and templates will be stored within ORLAU at RJAH. ORLAU building access is 
restricted by a reception desk and a password-protected locked door. Any electronic data of participants 
will also be copied and saved onto RJAH servers, which are protected under NHS electronic security. 
The research team will only have access to the participant NHS records once the participant has been 
consented for the study.  
 
                                                          
1  Available at, respectively:; https://goo.gl/muBtwD; https://www.rjah.nhs.uk/Patient-Visitors/Data-Protection.aspx; 
https://www.legislation.gov.uk/ukpga/2018/12/contents/enacted; https://ico.org.uk/for-organisations/guide-to-data-
protection/guide-to-the-general-data-protection-regulation-gdpr/ 

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Once the study is concluded, all appropriate paper-based forms of participants will be moved and stored 
in a locked cabinet at ORLAU for 10 years, then they will be destroyed. 
 
Confidentiality and anonymity will be maintained for all participants. Any identifying information provided 
(e.g. names and addresses) will be held in the strictest confidence and stored in a confidential, password 
protected database accessible by only those with permission. All data used for analysis will be kept 
separate from participant personal data. Hard copy material (e.g. signed consent forms) will be stored 
securely for a minimum period of 10 years after the study has been completed. After that period all hard 
copy material will be reviewed, and approval for destruction from the sponsor will be sought. All study 
participants will be allocated a unique identification number, therefore, making it possible to anonymise 
research data. All sensitive datasets will be retained on a secure server and access restricted to the 
study team. Access to all research datasets is controlled by password protection and additional 
permissions specific to folders. 
 
All confidentiality arrangements adhere to relevant regulations and guidelines (General Data Protection 
Regulation 2018, Data Protection Act 2018, General Medical Council (GMC), Medical Research Council 
(MRC), Research Governance Framework) and the chief investigator has a responsibility to ensure the 
integrity of the data and that all confidentiality procedures are followed 
 
9.3 
Access to Data 
Only members of the ORLAU clinical team, students and clinical supervisors will have access 
participants' personal data for the duration of the study. The principal investigator is already part of the 
direct healthcare team on-site. Other members of the research team will only have access to 
anonymised data. Members of staff from the sponsor and/or regulatory bodies may also require access 
to study participant's data in order to carry out audits. All these staff work to robust data security 
procedures. 
 
The raw data will be generated and stored electronically on an NHS-secured computer. Only 
anonymised data will be transferred to an encrypted university laptop. The researcher, academic 
supervisor, the principal investigator and clinical supervisors will be involved in the analysis of data. 
Other members of the research team will only have access to anonymised data. The anonymised 
dataset will stored on the University of Liverpool data repository2, the anonymised data will be openly 
available.  
 
                                                          
2 http://datacat.liverpool.ac.uk/ 

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Paper-based data will be stored at RJAH in a locked cabinet, and Electronic data will be stored on RJAH 
hospital Trust servers, which have restricted access by a two-way authentication procedure. Paper-
based data will be kept on-site for 10 years and will be destroyed after the sponsors approval. Dr 
Caroline Stewart is the custodian of the data, as she is the manager of ORLAU. ORLAU entrance is 
restricted by a reception desk and a locked door with passcode keypad. Accessibility to these data is 
governed by RJAH local hospital policies and. RJAH is the sponsor of this study, which makes it the 
owner of the data generated by this study, All of these guidelines are implemented to ensure these 
arrangements are in compliance with the Data Protection Act 2018, GDPR 2018 and Research 
Governance Framework. 
 
9.4 
Data Sharing Agreements 
The anonymised final trial dataset and anonymised 3D movement data files will be stored on the 
University of Liverpool and RJAH Data repositories where they will be assigned a Digital object identifier. 
The anonymised data will be openly available.  
 
9.5 
Archiving 
Study related data will be stored as per RJAH hospital policies, which are compliant with the NHS 
Retention schedules reported in Records Management Code of Practice for Health and Social Care 
20163.  Secondary anonymised data will be reported in the following data repositories: 
• 
RJAH 
• 
University of Liverpool 
In addition, the secondary anonymised data may be presented in a thesis, which will be archived as per 
University of Liverpool guidelines.   
 
Paper-based data will be kept on-site for 10 years and will be destroyed after the sponsors approval. Dr 
Caroline Stewart is the custodian of the data, as she is the manager of ORLAU. Accessibility to these 
data is governed by RJAH local hospital policies. RJAH is the sponsor of this study, which makes it the 
owner of the data generated by this study. 
 
 
                                                          
3 Available at: https://digital.nhs.uk/binaries/content/assets/legacy/pdf/n/b/records-management-cop-hsc-2016.pdf   

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10 MONITORING & AUDIT 
10.1 Safety Reporting 
A complication of shoulder instability is increased risk of further episodes of shoulder instability. In order 
to minimise the risk, for children with shoulder instability the first assessment will be conducted a 
minimum of 12 weeks from their most recent episode of instability. This time point has been selected 
from experience in managing this patient group and after further discussion with our clinical partners to 
identify a suitable time point which minimises the risk of recurrent instability, ensures the measurements 
do not exacerbate participant symptoms and allows them to complete the required tasks. The movement 
tasks for analysis have also been selected to minimise any risks of instability. 
 
We do not anticipate participants as having episodes of instability during the measurement sessions. 
However, if participants do suffer a dislocation during the measurement session which does not 
spontaneously reduce/resolve, there is emergency care available on site and the participant will be 
managed according to the RJAH hospital trust procedures. The principal investigator is already part of 
the direct healthcare team on-site. A monthly meeting with the research team will be regularly held to 
discuss the conduct of the study, including adverse events Safe practice and Risk Assessment.  
 
11 ETHICAL AND REGULATORY CONSIDERATIONS 
The study will be submitted for approval by the HRA through which REC approval will be obtained.  The 
study team will provide the REC with a copy of the final protocol, patient information sheets, consent 
forms and all other relevant study documentation as part of the HRA approval process. The chief 
investigator will ensure that REC approval is obtained prior to recruitment of any participants in the 
study. Before any site can enrol patients into the study, the Chief Investigator will ensure that appropriate 
approvals from participating organisations are in place. 
 
For any amendment to the study, the Chief Investigator, in agreement with the sponsor will submit 
information to the appropriate body in order for them to issue approval for the amendment. The Chief 
Investigator will work with sites so they can put the necessary arrangements in place to implement the 
amendment and to confirm their support for the study as amended. Substantial amendments that require 
review by NHS REC will not be implemented until that review is in place and HRA approval obtained for 
the amendment.  
 
All correspondence with the REC will be retained. An annual progress report (APR) will be submitted to 
the REC within 30 days of the anniversary date on which the favourable opinion was given, and annually 
until the study is declared ended. 
 

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The Chief Investigator will take overall responsibility to produce annual reports as required. Within one 
year after the end of the study, the Chief Investigator will submit a final report with the results, including 
any publications/abstracts, to the REC. 
 
The Chief Investigator will notify the REC of the end of the study. If the study is ended prematurely, the 
Chief Investigator will notify the REC, including the reasons for the premature termination. 
 
The following stages have been taken to address the ethical considerations and minimisation of 
measurement burden for our study, therefore ensuring the safety of participants. 
 
A complication of shoulder instability is increased risk of further episodes of shoulder instability. In order 
to minimise the risk, for children with shoulder instability the first assessment will be conducted a 
minimum of 12 weeks from their most recent episode of instability. This time point has been selected 
from experience in managing this patient group and after further discussion with our clinical partners to 
identify a suitable time point which minimises the risk of recurrent instability, ensures the measurements 
do not exacerbate participant symptoms and allows them to complete the required tasks. The movement 
tasks for analysis have also been selected to minimise any risks of instability. Participants will also be 
informed that they may stop the movement activities should their symptoms or discomfort worsen during 
testing. 
 
We do not anticipate participants as having episodes of instability during the measurement sessions. 
However, if participants do suffer a dislocation during the measurement session which does not 
spontaneously reduce/resolve, there is emergency care available on site and the participant will be 
managed according to the trust procedures. 
To record participant’s movements, markers and devices will be placed on the skin using hypoallergenic 
medical adhesive tape. This is routine clinical practice in movement analysis laboratories and those 
conducting data collection will be trained in the application and removal of the markers. Some discomfort 
may be experienced by participants during marker and device removal, in the worst case it would be 
equivalent to that of a plaster being removed.  
 
A monthly meeting with the research team will be regularly held to discuss the conduct of the study, 
including adverse events Safe practice and Risk Assessment.  
 
Measurement burden 
In order to minimise the measurement burden on all participants and ensure the aims of the study are 
met, our study design has been developed following input from a Public Involvement and Engagement 

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(PPIE) group, an additional 7 children of appropriate age groups outside of the PPIE and clinicians who 
routinely work with children with shoulder instability. 
 
A primary aim of our study is to test the reliability and variability of a measurement analysis protocol in 
children with shoulder instability and age-matched controls. To minimize the measurement burden on 
children and their parent/carer/guardian, only a single study site visit, lasting a maximum of 2 hours 30 
minutes, is required. Reliability will be determined by a sensitivity analysis in which we will virtually 
pertubate the markers post data collection. This has been selected to minimise the measurement burden 
of multiple visits for children with shoulder instability and the age matched controls. For children with 
shoulder instability this will also minimise the variability which may arise as a result of the natural 
recovery process over time and confound our results. The measurement protocol has been designed 
after consultation with different children of appropriate age groups, clinicians and the scientific literature. 
 
Where possible, we will additionally try and accommodate measurement sessions outside of school 
hours for both groups to limit any school/lesson absences. 
 
Diaries and monthly telephone calls (lasting up to 12 months), have been selected to ensure accurate 
recordings of the events and minimise recall bias. We have received input re the follow up study 
processes and diaries from the Public Involvement and Engagement group and additional children of 
appropriate age groups. We do not anticipate that participants will have a large number of instability 
episodes and so the measurement burden for recording will be minimal. Additionally, participants will 
only be asked to record when an episode happens. 
 
11.1 Peer review 
This research is being funded by The Private Physiotherapy Education Foundation and as a part of the 
process has undergone peer review.  
11.2 Public and Patient Involvement 
 
Please see below the info from the PPIE group and subsequent actions as a result of the PPIE feedback. 
PPIE feedback 
Comments and actions 
Firstly, the group really saw value in the project especially as 
your presentation stated rehabilitation was preferred over 
surgical methods however reported failure rates were as high 
as 90%, the group were shocked about this so felt it was an 
incredibly important topic to research and would be value for 
money as if the issue could be solved the first time it would 
save money in the long run from no repeat complications.  
We have responded to the PPIE group to and 
thanked them for their involvement. We are 
pleased that they recognized the value of the 
research. 

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The diary 
The group weren't sure that both diary's were needed maybe 
just one. They felt they were nice a simple but just suggested 
giving an example of how to fill out above the table e.g. 
format of date time and example of activity.  
 
 
We have selected a single diary and provided 
an example of how to fill it in. 
The Posters 
 
The group thought they were nice and simple.  
i. 
They didn't like the picture of the girl as she was too 
happy and if she had suffered shoulder discomfort 
she wouldn't be that happy.  
ii. 
They felt the picture of the shoulder was much better 
but felt it would be more relevant if it was a child's 
shoulder. 
 
 
iii. 
Within the poster they weren't sure the word 
subluxated was needed as this was really difficult to 
understand and thought most people understood 
dislocated and popped out.  
iv. 
Under the second paragraph maybe put if you are a 
child aged ......... and have experienced your shoulder 
being popped out.  
v. 
Under this the group thought it was really important 
to give a very brief description of what was involved 
in the study or no-one might respond. Especially as 
the study doesn't involve much but if it doesn't state 
that it might put people off.  
vi. 
The last section after would you/your child like to 
help us by participating in the study add in for more 
information call....  
vii. 
The very last line about travel expenses they felt 
wasn't really necessary but if it was to be left in to 
make it a smaller font.  
viii. 
They felt posters could be put in clinics, especially 
minor 
injuries, 
fracture 
clinics 
and 
children's outpatients but also back of toilets doors 
as this was a place that most people read 
information.  
 
 
 
i. 
An 
alternate 
picture has 
been 
selected. 
 
 
ii. 
We have used the shoulder picture as 
we were unable to find an alternate 
picture (with the correct licensing) 
that accurately reflected the study 
and what it involves.  
iii. 
The word subluxated has been 
removed 
from 
the 
study 
advertisement to increase readability 
 
iv. 
The wording has been changed to 
increase readability 
 
v. 
A brief description and some further 
images have been included in the 
advertisement.  
 
 
 
 
vi. 
The wording has been changed to 
reflect the feedback from the PPIE 
group 
vii. 
The font has been made smaller to 
reflect the feedback from the PPIE 
group 
viii. 
Where possible we will try and place 
the posters in the suggested places. 
The PIL (Participant Information Leaflet) 
 
 
 

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I have attached these with the changes.  
i. 
The under 16 they thought was a good size and 
overall really well written. (which is a big compliment 
from them) 
ii. 
The only thing they felt needing adding was about 
you don't have to take part or could choose to stop 
taking part at any time and no-one would mind  
iii. 
The over 16 They thought could be condensed to 4 
pages however for an adult leaflet they thought it 
wasn't too long and was much easier to understand 
than most adult leaflets 
iv. 
Overall they thought both were good information 
leaflets.  
 
 
i. 
We were please to read this and when 
adding further information have kept 
the same writing style and level. 
ii. 
We 
have 
added 
the 
wording 
suggested by the PPIE group re 
choosing to stop taking part. 
iii. 
Where possible we have tried to 
condense these without removing 
any pertinent information. 
 
iv. 
We were 
please 
to read 
the 
comments re quality of the leaflets 
• 
The group definitely understood the project and 
were keen to find out much such as did you think the 
study would lead to the result of more surgeries.  
• 
They are happy to be involved throughout the project 
if that is something you would like.  
• 
They wanted to know about your plans for 
dissemination to participants and especially the 
public?  
 
 We have responded to the PPIE group and 
indicated that we would like for them to be 
involved in the project. We have also 
indicated that we have plans to disseminate 
our 
work 
through 
scientific 
journals, 
presentations (scientific, lay and to the PPIE 
group) and  would value their help. 
Hope this has helped if you need any more information/ help 
please do not hesitate to contact me best wishes with the 
funding. 
 
Thanks 
 
 
 
11.3 Data protection and patient confidentiality 
Each participant will be issued a unique participant study number which will be exclusively used in any 
paper-based forms to ensure that participants cannot be identifiable in case the forms are 
misplaced/lost.  The use of a laptop with encryption would ensure that any electronically captured data 
would be secured.  All other non-anonymised data will be stored and kept securely at RJAH Hospital 
trust. This data management plan was developed ensure that data of this research is managed and 
shared in a robust and professional manner.  The plan was formulated with adherence to the United 
Kingdom Research and Innovation Data Policy, RJAH Hospital Trust Data Protection, Data Protection 

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Act 2018 and General Data Protection Regulation 20184.  All participant personal data will be 
anonymised. For images or videos included in published results, we have software which allows us to 
blur out participant faces and distinguishable features to maintain anonymity 
 
11.4 Financial and other competing interests for the chief investigator, PIs at each site and 
committee members for the overall study management 
There are no financial or any other competing interests to declare for the chief investigator or any 
other members of the research team. 
 
11.5 Indemnity 
RJAH has in place a broad clinical trial insurance cover that applies equally to CTIMPs and Non-CTIMPs 
and Device Trials. This insurance would cover study management, design and conduct.  The NHS has 
a duty of care to patients treated, whether or not the patient is taking part in a clinical research study, 
and the NHS organisation remains liable for clinical negligence and other negligent harm to patients 
under this duty of care. 
 
11.6 Access to the final trial dataset 
Study related data will be stored as per RJAH hospital policies, which are compliant with the NHS 
Retention schedules reported in Records Management Code of Practice for Health and Social Care 
20165.  Secondary anonymised data will be reported in the following data repositories: 
• 
RJAH 
• 
University of Liverpool 
In addition, the secondary anonymised data may be presented in a thesis, which will be achieved as per 
University of Liverpool guidelines. Within the University of Liverpool Data repository, the respective 
datasets will be assigned a DOI. The anonymised data will be openly available for research and 
academic use. 
 
 
 
 
                                                          
4  Available at, respectively: https://goo.gl/muBtwD; https://www.rjah.nhs.uk/Patient-Visitors/Data-Protection.aspx; 
https://www.legislation.gov.uk/ukpga/2018/12/contents/enacted; https://ico.org.uk/for-organisations/guide-to-data-
protection/guide-to-the-general-data-protection-regulation-gdpr/ 
5 Available at: https://digital.nhs.uk/binaries/content/assets/legacy/pdf/n/b/records-management-cop-hsc-2016.pdf   

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12 REFERENCES 
• 
Deitch, J., et al., Traumatic anterior shoulder dislocation in adolescents. The American journal of 
sports medicine, 2003. 31(5): p. 758-763. 
• 
Marx, R.G., et al., Development of arthrosis following dislocation of the shoulder: A case-control study. 
Journal of Shoulder and Elbow Surgery, 2002. 11(1): p. 1-5. 
• 
Longo, U.G., et al., Surgical Versus Nonoperative Treatment in Patients Up to 18 Years Old With Traumatic 
Shoulder Instability: A Systematic Review and Quantitative Synthesis of the Literature. Arthroscopy, 2016. 
32(5): p. 944-52. 
• 
Jaspers, E., et al., Upper limb kinematics: development and reliability of a clinical protocol for children. 
Gait Posture, 2011. 33(2): p. 279-85. 
• 
Jaspers, E., et al., The reliability of upper limb kinematics in children with hemiplegic cerebral palsy. Gait 
& Posture, 2011. 33(4): p. 568-575. 
• 
Delp, S.L., et al., OpenSim: open-source software to create and analyze dynamic simulations of movement. 
IEEE Trans Biomed Eng, 2007. 54(11): p. 1940-50. 
• 
Seth, A., et al., OpenSim: Simulating musculoskeletal dynamics and neuromuscular control to study human 
and animal movement. PLoS Comput Biol, 2018. 14(7): p. e1006223. 
• 
Barden, J.M., et al., Atypical shoulder muscle activation in multidirectional instability. Clinical 
Neurophysiology, 2005. 116(8): p. 1846-1857. 
• 
Barrett, C., The clinical physiotherapy assessment of non-traumatic shoulder instability. Shoulder & elbow, 2015. 
7(1): p. 60-71. 
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McFarland, E.G., et al., The effect of variation in definition on the diagnosis of multidirectional instability of 
the shoulder. JBJS, 2003. 85(11): p. 2138-2144. 
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Bateman, M., A. Jaiswal, and A.A. Tambe, Diagnosis and management of atraumatic shoulder instability. 
Journal of Arthroscopy and Joint Surgery, 2018. 5(2): p. 79-85. 
• 
Best, M.J. and M.J. Tanaka, Multidirectional Instability of the Shoulder: Treatment Options and 
Considerations.Sports Medicine and Arthroscopy Review, 2018. 26(3): p. 113-119. 
• 
Cordasco, F.A., Understanding Multidirectional Instability of the Shoulder. Journal of Athletic Training, 2000. 
35(3): p. 278-285. 
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Harryman, D.T., et al., Laxity of the normal glenohumeral joint: A quantitative in vivo assessment. Journal 
of Shoulder and Elbow Surgery, 1992. 1(2): p. 66-76. 
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Hovelius, L. and M. Saeboe, Neer Award 2008: Arthropathy after primary anterior shoulder dislocation–223 
shoulders prospectively followed up for twenty-five years. Journal of Shoulder and Elbow Surgery, 2009. 
18(3): p. 339-347. 
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Inui, H., et al., Three-dimensional relationship of the glenohumeral joint in the elevated position in shoulders 
with multidirectional instability. Journal of Shoulder and Elbow Surgery, 2002. 11(5): p. 510-515. 
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Jaggi, A. and S. Lambert, Rehabilitation for shoulder instability. British Journal of Sports Medicine, 2010. 
44(5): p. 333-340. 
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Jaggi, A., et al., Muscle activation patterns in patients with recurrent shoulder instability. Int J Shoulder 
Surg, 2012. 6(4): p. 101-7. 
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Leroux, T., et al., The epidemiology of primary anterior shoulder dislocations in patients aged 10 to 16 years. 
Am J Sports Med, 2015. 43(9): p. 2111-7. 
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Marchi, J., D. Blana, and E.K. Chadwick, Glenohumeral stability during a hand-positioning task in 
previously injured shoulders. Med Biol Eng Comput, 2014. 52(3): p. 251-6. 
• 
Philp, F., et al., Study of the measurement and predictive validity of the Functional Movement Screen. 
BMJ Open Sport & Exercise Medicine, 2018. 4(1). 
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Philp, F., et al., “Dynamic knee valgus” – are we measuring what we think we’re measuring? An evaluation 
of static and functional knee calibration methods for application in gait and clinical screening tests of the 
overhead squat and hurdle step. Gait & Posture, 2019. 
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Ameln, D.J.D., et al., The Stabilizing Function of Superficial Shoulder Muscles Changes Between Single-
Plane Elevation and Reaching Tasks. IEEE Trans Biomed Eng, 2019. 66(2): p. 564-572. 
• 
Chadwick, E.K., et al., Real-time simulation of three-dimensional shoulder girdle and arm dynamics. 
IEEE Transactions on Biomedical Engineering, 2014. 61(7): p. 1947-1956. 
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Chadwick, E., A. Van Noort, and F. Van Der Helm, Biomechanical analysis of scapular neck malunion–
–a simulation study. Clinical biomechanics, 2004. 19(9): p. 906-912. 
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Magermans, D., et al., Biomechanical analysis of tendon transfers for massive rotator cuff tears. 
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Veeger, H., et al., A kinematical analysis of the shoulder after arthroplasty during a hair combing task. 
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Parel, I., et al., Motion analysis of the shoulder in adults: kinematics and electromyography for the 
clinical practice. Eur J Phys Rehabil Med, 2016. 52(4): p. 575-82. 
• 
Philp, F., Validating models of injury risk prediction in football players, in School of Health and 
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13 APPENDICIES 
13.1 Appendix 1 - Study management / responsibilities 
Name 
Main duties 
Fraser Philp 
Chief investigator 
Oversight and management of the project including weekly/monthly review 
meetings,  liaising/corresponding with stakeholders, recruitment sites and funding 
body, overseeing recruitment and data collection procedures, training and 
supervision of research assistant, data analysis, interpretation of results, 
preparation of materials for dissemination. 
Sarah Jarvis 
Principle Investigator (Senior Physiotherapist) 
Monthly review meetings, overseeing and undertaking data collection at hospital site,
training of research assistant, data processing, interpretation of results, preparation
of materials for dissemination  
Robert Freeman Co-investigator (Consultant Orthopaedic Surgeon) 
 
Monthly review meetings, recruitment, interpretation of results, preparation of
materials for dissemination. 
Research 
Assistant 
*Starting in post 12 months following project start date. 
Data processing and analysis including biomechanical modelling using 
OpenSim, data collection/ patient telephone follow ups for recurrence rates,  
preparation of materials for dissemination. 
Ed Chadwick 
Co-investigator/ Research supervisor 
Monthly review meetings, training of research assistant, interpretation of results, 
preparation of materials for dissemination. 
Anand Pandyan 
Co-investigator/ Prof of Rehabilitation Technology 
Involvement of monthly review meetings, training of research assistant, 
interpretation of results, preparation of materials for dissemination, monitoring 
financial spending of the project.