Dynamic Lycra Garments to Address Pain and Instability Associated With Hip Dysplasia: a Single Cohort Observational Pilot Study
Phase: NA
Conditions: Hip Dysplasia, Hypermobility Syndrome
Sponsor: Royal National Orthopaedic Hospital NHS Trust

 
 
 
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FULL/LONG TITLE OF THE STUDY 
 
A single centre, feasibility study using 
Dynamic Lycra Garments to address pain and 
instability associated with Hip Dysplasia 
SHORT STUDY TITLE / ACRONYM 
 
HIP Lycra study 
PROTOCOL VERSION NUMBER AND DATE 
 
Version 1.0, 25/08/2025  
IRAS Number: 
342748   
Study Sponsor:  
Royal National Orthopaedic Hospital (RNOH) 
NHS Trust  
Sponsor Reference Number 
342748 
Funder Reference Number: 
In house funding 
This protocol has regard for the HRA guidance and order of content 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to 
the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory 
requirement. 
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 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. 
 
For and on behalf of the Study Sponsor: 
Signature:  
...................................................................................................... 
 
Date: 
....../....../...... 
Name (please print): 
Ira Jakupovic 
 
 
Position: Head of Research and Innovation Centre (RIC) 
 
 
 
Chief Investigator: 
Signature: 
...................................................................................................... 
 
Date: 
....../....../...... 
Name: (please print): 
Jim Ashworth-Beaumont,  
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Contents 
SIGNATURE PAGE ...................................................................................................................... ii 
KEY STUDY CONTACTS ............................................................................................................. v 
STUDY SUMMARY ...................................................................................................................... v 
FUNDING AND SUPPORT IN KIND ......................................................................................... vi 
ROLE OF STUDY SPONSOR AND FUNDER ........................................................................... vi 
ROLES AND RESPONSIBILITIES OF STUDY MANAGEMENT COMMITEES/GROUPS 
& INDIVIDUALS ............................................................................................................. vi 
PROTOCOL CONTRIBUTORS ................................................................................................... vi 
STUDY FLOW CHART ............................................................................................................. viii 
ABBREVIATIONS ....................................................................................................................... ix 
STUDY PROTOCOL .................................................................................................................... 10 
1. 
BACKGROUND ...................................................................................................................... 10 
2. 
RATIONALE ........................................................................................................................... 10 
3. 
THEORETICAL FRAMEWORK .............................................................................................. 10 
4. 
RESEARCH QUESTION/AIM(S) ............................................................................................ 11 
4.1 
Objectives ......................................................................................................................... 11 
4.2 
 Outcome .......................................................................................................................... 11 
5. 
STUDY DESIGN, METHODS OF DATA COLLECTION AND DATA ANALYSIS ................... 12 
5.1 
Definition of end of study ................................................................................................... 13 
6. 
STUDY SETTING ................................................................................................................... 13 
7. 
SAMPLE AND RECRUITMENT .............................................................................................. 13 
7.1 
Eligibility Criteria ............................................................................................................... 13 

 
 
 
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7.2 
Inclusion criteria ................................................................................................................ 14 
7.3 
Exclusion criteria ............................................................................................................... 14 
7.4 
Sampling ........................................................................................................................... 14 
7.5 
Size of sample .................................................................................................................. 14 
7.6 
Sampling technique .......................................................................................................... 14 
7.7 
Recruitment ...................................................................................................................... 14 
7.8 
Participant identification .................................................................................................... 15 
7.9 
Consent ............................................................................................................................ 15 
7.10 Consent provisions for collection and use of participant data and biological specimens .... 15 
8. 
ETHICAL AND REGULATORY CONSIDERATIONS ............................................................. 15 
8.1 
Assessment and management of risk ............................................................................... 15 
8.2 
Research Ethics Committee (REC) and other Regulatory review & reports ....................... 16 
8.3 
Regulatory Review & Compliance ..................................................................................... 16 
8.4 
Amendments ..................................................................................................................... 16 
8.5 
Peer review ....................................................................................................................... 16 
8.6 
Patient & Public Involvement ............................................................................................. 16 
8.7 
Protocol compliance .......................................................................................................... 16 
8.8 
Data protection and patient confidentiality ......................................................................... 17 
8.9 
Indemnity .......................................................................................................................... 17 
8.10 Access to the final study dataset ....................................................................................... 17 
9. 
DISSEMINATION POLICY ..................................................................................................... 17 
9.1 
Dissemination policy ......................................................................................................... 17 
9.2 
Authorship eligibility guidelines and any intended use of professional writers ................... 18 
9.3 
Archiving Arrangements .................................................................................................... 18 
10. 
REFERENCES ..................................................................................................................... 19 
11 
APPENDICES ......................................................................................................................... 20 
Appendix 1 – Amendment History ................................................................................................... 20 
 
 
 

 
 
 
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KEY STUDY CONTACTS 
Chief Investigator 
Jim Ashworth-Beaumont, 
Orthotics Department, Royal National Orthopaedic Hospital 
NHS Trust (RNOH), Brockley Hill Middx HA7 4LP 
Jim.ashworth-beaumont@nhs.net  
0208 909 5418 
Mobile: 07985 552258 
Study Co-ordinator 
Katie Monnington, Physiotherapist, Physiotherapy 
Department, RNOH 
katie.monnington@nhs.net  
020 3947 0100 
Sponsor 
Ira Jakupovic 
Research & Innovation Centre, 
Royal National Orthopaedic Hospital NHS Trust, 
Brockley Hill, Stanmore, 
HA7 4LP 
ira.jakupovic1@nhs.net   
Joint-sponsor(s)/co-sponsor(s)  
n/a 
Funder(s) 
n/a 
Key Protocol Contributors 
Details as above 
Committees 
n/a 
 
STUDY SUMMARY 
Study Title 
A single centre, feasibility study using Dynamic Lycra 
Garments to address pain and instability associated with Hip 
Dysplasia 
Internal ref. no. (or short title) 
Dynamic Lycra Garments for hip dysplasia 
Study Design 
Feasibility/pilot study. Prospective, non-blinded, non-
controlled. Single Centre. 
Study Participants 
Consenting patients receiving standard care + dynamic lycra 
garment intervention 
Planned Size of Sample (if applicable) 8-12 
Follow up duration (if applicable) 
12 weeks 
Planned Study Period 
1 year October 2025 – 1 October 2026 
Research Question/Aim(s) 
 
The research question underpinning the project is as follows, 
“Can the use of dynamic compression shorts during daily 

 
 
 
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activities improve short term treatment outcomes in hip 
dysplasia patients?”. 
This feasibility study will assess prevalence of hip dysplasia 
and hypermobility, refine the research protocol and measures, 
identify any complications of garment use, establish 
compliance and feedback on aspects of experience; gathering 
early evidence of effect and establish potential for future 
interventional study.  
The intention of this study is primarily to establish the 
practicality of studying these effect of the garments over the  
period of a study, gather the opinions of patients and thereby 
allow us to assess the justification for further quantitative study, 
rather than the adjunctive effect of the shorts themselves.  
The findings will inform the development of a study design 
which can more fully establish the generalisable degree to 
which this intervention can deliver effective relief from pain and 
disability for patients with hypermobility and hip dysplasia. 
 
 
 
FUNDING AND SUPPORT IN KIND 
FUNDER(S) 
(Names and contact details of ALL organisations 
providing funding and/or support in kind for this 
study) 
A feasibility study to be undertaken with in house 
funding at this stage.  
 
ROLE OF STUDY SPONSOR AND FUNDER 
 
The study sponsor retains management of the study design, conduct, data analysis and interpretation, 
manuscript writing, and dissemination of results and controls the final decision regarding any of these 
aspects of the study. 
 
ROLES AND RESPONSIBILITIES OF STUDY MANAGEMENT COMMITEES/GROUPS & 
INDIVIDUALS 
 
This is a feasibility study. 
 
PROTOCOL CONTRIBUTORS 
 
The research team (CI, PI) assume responsibility for the study design, conduct, data analysis and 
interpretation, manuscript writing, and dissemination of results.  
The sponsor controls the final decision regarding any of these aspects of the study. 
A goal of this study is to gain informed feedback and opinion from members of the patient group of 
interest. 
 

 
 
 
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KEY WORDS: 
Hip Dysplasia 
Hypermobility 
Ehlers Danlos Syndrome 
Dynamic lycra garments 
Orthotics 
Physiotherapy 
  
 
 
 

 
 
 
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STUDY FLOW CHART 
Fig 1: Patient information flowchart outlining the hip lycra garment study procedures. Participants may 
withdraw consent and exit the study at any point, without giving a reason. 
 

 
 
 
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ABBREVIATIONS 
AE  
Adverse Event  
AR  
Adverse Reaction  
CI  
Chief Investigator  
CRF  
Case Report Form  
DDH 
Developmental Dysplasia of the Hip 
DLS 
Dynamic Lycra Shorts 
GCP  
Good Clinical Practice  
GP  
General Practitioner  
HRA 
Health Research Authority  
ICF  
Informed Consent Form  
ISF  
Investigator Site File  
NHS  
National Health Service  
NIHR  
National Institute for Health Research  
PI  
Principal Investigator  
REC 
Research Ethics Committee 
RNOH 
Royal National Orthopaedic Hospital 
NHS Trust 
SAE 
Serious Adverse Event 

 
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STUDY PROTOCOL 
A singe centre, feasibility study using Dynamic Lycra Garments to address pain and instability 
associated with Hip Dysplasia. 
1. 
BACKGROUND 
 
Muscle-tendon-related pain exists in about half of patients with hip dysplasia (DDH), the condition where 
the hip socket doesn't fully cover the ball portion of the upper thighbone, affecting patients' self-reported 
hip disability and muscle strength negatively (Jacobsen JS et al 2018). DDH has long been known to be 
a risk factor for pain and degenerative changes in the hip joint (Wilkin et al 2017). A strong association 
between hypermobility and DDH in adults has been shown (Santore et al 2020).  
Joint proprioceptive deficit is documented in a variety of musculoskeletal conditions including 
osteoarthritis, ligament and meniscal injuries, and individuals with increased joint hypermobility, such 
as those with Ehlers-Danlos Syndrome (EDS). A meta-analysis finding concluded that lower limb joint 
proprioception is reduced in those with benign joint hypermobility syndrome (BJHS) compared to non-
BJHS cohort (Smith et al 2013).  
Conservative treatment methodologies are important in addressing hip pain (Ladurner 2021). Lycra 
garments are deployed in rehabilitation and high-performance populations, the therapeutic effects of 
which are thought to arise from neurophysiological modulation of muscle tone, prolonged stretch to 
shortened muscles; mechanical dampening down of excessive, inefficient movement; supporting 
unstable areas of the body; and enhancing sensory feedback (Snowdon et al 2018).  
Postural correction has been shown to reduce hip pain in adult with acetabular dysplasia (Lewis et al 
2015) while lycra orthoses have reduced pain and improved stability in the shoulder (Matthews et al 
2015) and in the hip (Higo et al 2023). A range of primary and secondary outcome measures were 
deployed to show that, in a 4 week duration randomised control trial (RCT) of compression garments on 
EDS patient shoulder stability there was high satisfaction with improvement in focal pain, stability and 
function along with objectively measured high-speed power development, albeit with no significant carry 
over effect (Chaléat-Valayer et al, 2002). 
In summary it is possible that, in patients living with both DDH and joint hypermoblity dynamic lycra 
shorts (DLS) could be beneficial in reducing pain associated with posture and physical activity. The 
existing evidence to justify use in this population currently lacks both quality and strength.   
2. 
RATIONALE  
 
It is envisaged that the long-term aim of clinical trials programme by the research team will be to 
establish a generalizable evidence base for/against the use of lycra compression shorts to improve 
treatment outcomes in these populations. However, the scope of the current proposed feasibility study 
is limited to testing of the pathway and research protocol, participant adherence and feedback and 
gather early evidence of effect size, power calculation and to guide decision making as to whether this 
intervention is appropriate for further study and underpin funding applications (commercial/academic 
partners). 
3. 
THEORETICAL FRAMEWORK 
 
The intervention, dynamic lycra shorts, are a made-to-order CE marked item which are marketed 
towards treating the symptoms of joint hypermobility amongst many other pathologies. No generalisable 
peer-reviewed evidence currently exists to support their treatment effectiveness in the current population 
of interest, as an adjunct to current approach which is based around exercise and education. 
Furthermore, qualitative aspects of use of these highly compressive lycra garments, such as impact on 

 
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self-care or comfort, that could negatively impact on sustained use have not been explored in the peer-
reviewed literature. Before embarking upon a randomised trial it is important to confirm; 
the incidence of presentation of the target population, hypermobile DDH patients who are suitable for 
study inclusion. 
 
the fraction of whom are likely to consent and then choose to remain within the study protocol 
until the planned conclusion. 
 
extent of compliance with the intervention. 
 
identify aspects of the protocol that, through researcher and participant experience, may require 
modification. 
 
gain informed participant feedback as to the potential benefits of further research on this and 
similar topics.  
 
the incidence of anxiety and/or depression in the target population, which is thought to be 
common and could be an important variable in determining the outcome of treatment. 
4. 
RESEARCH QUESTION/AIM(S) 
 
The research question underpinning the project is as follows, “Can the use of dynamic compression 
shorts during daily activities improve short term treatment outcomes in hip dysplasia patients?”.  
In the context of this non-blinded, non-randomised cohort feasibility study the objective is to establish 
potential for further comparative interventional study. The primary outcome measure will be Functional 
status and health-related quality of life, as evaluated by the International Hip Outcome Tool 12 (iHOT 
12).  
Secondary outcomes applied are: 
 
Hip degree of motion strength testing- force  
o measured by hand dynamometer 
 
Goal Attainment Scaling (GAS) questionnaire 
o evaluating the extent to which patient's individual goals are achieved over the course of 
study intervention in the categories sport/recreation, occupation, social, lifestyle 
 
Hospital Anxiety & Depression Scale  
o Effect on mental health  
 
OPUS HQOL STATUS (2014) 
 
OPUS LOWER EXTREMITY FUNCTIONAL STATUS (2014) 
 
OPUS SATISFACTION (2014) Qs 1-9 fit and comfort of the Orthotic garment intervention. 
o These subscales are used for prosthetic and orthotic programs for quality assessment, 
to maintain awareness of improvement in activities, to evaluate changes in patient's 
functional status and quality of life, and to assess satisfaction with devices and services. 
4.1 
Objectives 
 
This study is intended to establish the experience of patients within the limited duration of the study, of 
prescribed exercise wearing the shorts and also daily use of the shorts in self-selected sport, leisure 
and activities of daily living. An important aspect of the study is to establish the importance of underlying, 
secondary or negative factors that may contribute to the net treatment effect. Thus, we will gather 
valuable information about the feasibility of using this garment, not only as part of a limited term 
intervention for study or treatment but their effect on an individual's quality of life and practicality as an 
aid for longer term use. 
4.2 
 Outcome 
 

 
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This feasibility study will refine the research protocol and measures, identify any complications of 
garment use, establish compliance and feedback on aspects of experience; gathering early evidence of 
effect and establish potential for future interventional study. The intention of this study is primarily to 
establish the practicality of studying the effects of the garments over the period of a study and assess 
the justification for further quantitative study, rather than the adjunctive effect of the shorts themselves. 
The findings will inform the development of a study design which can more fully establish the 
generalisable degree to which this intervention can deliver effective relief from pain and disability for 
patients with hypermobility and hip dysplasia. 
5. 
STUDY DESIGN, METHODS OF DATA COLLECTION AND DATA ANALYSIS 
 
This prospective, 2 x repeated measures, non-blinded, non-controlled study will invite a cohort of 
patients to take part in a study that combines usual care with adjunctive use of DLS for a limited period 
of 8-12 weeks, in accord with the Declaration of Helsinki.  
The null hypothesis in relation to the primary outcome measure can be stated as follows: 'use of dynamic 
compression shorts during daily activities does not modify the degree of pain experienced by hip 
dysplasia patients.'  
Protocol: Patient screened by the clinical care team,  will be invited to participate by the medical team, 
based upon the inclusion and exclusion criteria specified. They will be provided with an information 
sheet (PIS). The medical team will pass the prospect's details to the research team who will 
subsequently make contact to invite to the initial, face to face baseline session. If the patient for any or 
no reason declines to continue at this or any point, they will continue on the standard treatment pathway.  
 
Recruitment session: If the patient agrees to attend, they will attend at the research site. The 
researcher will affirm that the prospects have read and understood the PIS information. Written consent 
will be sought and witnessed. Hypermobility status will be evaluated. The shorts will be measured (a 
single circumferential tape measure at the level of the anterior superior iliac crests (ASIS)). The 
participant will complete a HADS 10 evaluation form. Following the session the participant’s GP will be 
sent a study notification letter. 
 
The shorts have an order-to-delivery time of 2 weeks. Following delivery of these to the research 
site, the following activities will take place in sessions/intervals as follows 
1. Baseline session. i. strength testing, questionnaires and interview completion. ii. shorts fitting 
and education, standardised method. Orthosis and exercise education will then be provided.The 
outcome measures gathered at baseline and followup will include: iHOT-12 questionnaire 
Orthotics Prosthetics Users Survey (OPUS) satisfaction subscales Hand Dynamometer - muscle 
strength by hip degree of movement.  
Participants will be directed to wear the lycra shorts during all daily activity and physiotherapy 
exercise, where possible and diarise their experiences.  
 
2. Intervention window. During the 12 weeks home trial period each participant will complete a 
formatted daily exercise and lycra garment intervention diary. Participants will be provided with 
a support contact telephone/email. All contact will be fully summarised in the participant activity 
timeline log.]  
 
3. Follow up session: strength testing, follow up and repeat OPUS questionnaires and interview. 
Participant debrief either during this session or as a follow up communication. 
 

 
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4. At the study conclusion each participant will be asked to complete an interview and receive a 
debrief of their personal study data. They will be asked to reflect upon their qualitative experience 
and perceived personal and generalisable benefits of current and planned research into such 
conservative therapies. 
 
Data will be collected using paper Case Report Forms (CRFs) designed by the research teams  and 
stored in locked cabinets within the clinical facility.  
 
The scores from the validated questionnaires, patient diaries and comments recorded at follow-up will 
be digitised and recorded on secure databases. As is appropriate in a small-scale study, quantitative 
results will be considered as descriptives such as mean, median, mode, percentage, frequency, 
skewness, and range. Qualitative data will be evaluated by analysing the content for systematic themes, 
patterns and features in participant experience.  
 
All databases used during the study will be on password and firewall protected, NHS Trust proprietary 
systems and private cloud channels accessible only the research team. 
Participant-specific study records will be anonymised by coding, with administrative decoding under the 
control of Principal Investigator (PI) only, in accordance with the NHS Code of Practice for 
Confidentiality. 
 
Where hard copy records or questionnaires are generated during the study, these will be scanned 
electronically, and the hard copies will be destroyed. Research data will be stored on password 
protected Trust systems and accessible only by the research team.  
Research data will be stored for 5 years following completion of the study. Personal data will be stored 
and accessed for the limited period of 12 months. 
5.1 
Definition of end of study 
 
At conclusion of the Follow-up session at 12-week point. Last patient last visit.  
6. 
STUDY SETTING 
 
The initial approach to potential participants will be made by the Principal Investigator (PI) who is a 
senior member of the RNOH Hip Unit Therapies healthcare team. The PIS makes clear that the study 
activities will be carried out adjunctively, rather than as an alternative, to standard care. 
As a single centre study, all participant contact will take place within Outpatient Physiotherapy 
Department at RNOH, where standard treatment will be provided in addition to the DLS intervention. 
 
7. 
SAMPLE AND RECRUITMENT 
 
7.1 
Eligibility Criteria 
 
Current treatment pathway, for hip dysplasia patients who are deemed appropriate for conservative 
treatment, is to be referred by the medical team to the Principal Investigator (PI) who triages all referrals. 
The PI is also the researcher responsible for executing the participant-facing research protocol. During 
the triage referrals the PI will identify and tag those prospective participants (prospects) who might be 
appropriate for inclusion. All patients attend a pre-treatment assessment appointment. During this 

 
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appointment, additional time will be allocated to discuss the study topic, pre-screen the prospects and 
issue the PIS if appropriate. Prospective participants will be given at least 24 hours to read the PIS and 
consider their participation in the study. Should the prospect signal their consent, they will be invited by 
the PI to a study baseline session where they will be given the opportunity to ask any questions. If they 
are happy to take part, informed, written consent will be gained. 
This is a single cohort study. 
7.2 
Inclusion criteria 
  
All patients passing through the RNOH Hip Unit, diagnosed with DDH suitable for conservative treatment 
with physiotherapy. 
 
Age 18 years or over. 
 
Both males and females. 
 
Able to attend the RNOH Stanmore site for in-person sessions. 
7.3 
Exclusion criteria 
  
 
Less than 18 years of age. 
 
Diagnosed other musculoskeletal pathology affecting hips or pelvis 
 
Prior surgical intervention to treat a lower limb disease/disorder 
 
Unable to attend the RNOH Stanmore site for in-person sessions. 
7.4 
Sampling 
 
Consecutive, sample of convenience. Current treatment pathway, for hip dysplasia patients who are 
deemed appropriate for conservative treatment, is to be referred by the medical team to the Principal 
Investigator who triages all referrals. The PI is also the researcher responsible for executing the participant-
facing research protocol. During the triage referrals the PI will identify and tag those prospective participants 
(prospects) who might be appropriate for inclusion. 
7.5 
Size of sample 
 
8-12, commensurate with the available population and the pilot/feasibility study design. 
7.6 
Sampling technique 
 
Sample of convenience. Current treatment pathway, for hip dysplasia patients who are deemed appropriate 
for conservative treatment, is to be referred by the medical team to the Principal Investigator who triages 
all referrals. The PI is also the researcher responsible for executing the participant-facing research protocol.  
During the triage of referrals, the PI will identify and tag those prospective participants (prospects) who 
might be appropriate for inclusion. 
7.7 
Recruitment 
 
During the triage referrals the PI will identify and tag those prospective participants (prospects) who 
might be appropriate for inclusion. 
All patients attend a pre-treatment assessment appointment. During this appointment, additional time 
will be allotted to discuss the study topic, screen the prospects and issue the PIS if appropriate.  
The initial approach to potential participants will be made by the Principal Investigator who is a member 
of the healthcare team. The PIS will make clear that the study activities will be carried out adjunctively, 

 
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rather than as an alternative, to standard care. Potential participants will be given at least 24 hours to 
read the PIS and consider their participation in the study. 
 
Should the prospect signal their consent, they will be invited by the PI to a study baseline session where 
informed, written consent will be gained. 
7.8 
Participant identification 
 
A member of the patient's existing clinical care team will be reviewing the referral details as part of standard 
triage protocol. During this referral triage process the PI will identify and tag those prospective participants 
(prospects) who might be appropriate for inclusion. 
All patients attend a pre-treatment assessment appointment. During this appointment, additional time will 
be allotted to discuss the study topic, screen the prospects and issue the PIS if appropriate. 
Participants will receive no payment for taking part in the study. However, participants will be able to retain 
the lycra shorts for continued use following conclusion of the study if the device proves to deliver personal 
benefit. Although this could be considered as a non-financial incentive to take part, the item will be provided 
as a prescribed item. 
7.9 
Consent 
 
All patients attend a pre-treatment assessment appointment. During this appointment, additional time 
will be allotted to discuss the study topic, screen the prospects, issue the PIS if appropriate and answer 
any questions the prospect may have. 
Should the prospect signal their consent, they will be invited by the PI to a study baseline session where 
informed, written consent will be gained prior to any study activities being undertaken. 
The Principal Investigator will take written consent.  
 
7.10 
Consent provisions for collection and use of participant data and biological specimens  
 
Participant-specific study records will be anonymised by coding, with administrative decoding under the 
control of Principal Investigator only, in accordance with the NHS Code of Practise for Confidentiality.  
Information on which data will be collected and held by the research team will be outlined in the PIS, 
and participants will provide specific consent for access to their medical notes by the research team.  
No biological specimens will be collected for this research study. 
8. 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
Patient reported outcomes will be gathered using validated questionnaire tools. Physiological (muscle 
strength) measurements will be gathered using standardised methods, in the clinical environment, by 
the PI, a registered senior Physiotherapist. 
The study design accords with the provisions of the Declaration of Helsinki 2024.  
 
8.1 
Assessment and management of risk 
 
It is possible that safeguarding issues may arise during the study, such as a participant reporting suicidal 
ideation. As all participants will be current Trust patients, the PI is able to flag concerns to RNOH Adult 
Safeguarding department for further assessment. 

 
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8.2 
Research Ethics Committee (REC) and other Regulatory review & reports 
 
Before the start of the study, a favourable opinion will be sought from a REC for the study protocol, 
informed consent forms and other relevant documents (e.g. advertisements), and HRA approval. 
Substantial amendments that require review by NHS REC/HRA will not be implemented until that review 
is in place and other mechanisms are in place to implement at site. All correspondence with the 
REC/HRA will be retained.  
 
It is the Chief Investigator’s responsibility to produce the annual reports as required. 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. 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. 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. 
8.3 
Regulatory Review & Compliance  
 
The trial will be conducted in accordance with the UK Policy Framework for Health and Social Care 
Research. Before any site can enrol patients into the study, the Chief Investigator/Principal Investigator 
or designee will ensure that the site is in receipt of appropriate REC/HRA approvals, they have issued 
confirmation of capacity and capability, and for multi-centre participating sites outside of RNOH, that 
they have been given Sponsor greenlight to start recruitment.  
8.4 
Amendments  
 
For any amendment to the study, the Chief Investigator or designee, in agreement with the sponsor will 
submit information to the appropriate body in order for them to issue approval for the amendment. It is 
the sponsor’s responsibility to decide whether an amendment is substantial or non-substantial for the 
purposes of submission. If applicable, other specialist review bodies (e.g. Confidentiality Advisory Group 
(CAG)) need to be notified about substantial amendments in case the amendment affects their opinion 
of the study. The Chief Investigator or designee will work with sites (R&D departments at NHS sites as 
well as the study delivery team) so they can put the necessary arrangements in place to implement the 
amendment to confirm their support for the study as amended. 
8.5 
Peer review 
 
This is a feasibility study, the study protocol and study documentation was internally reviewed by 
members of the Therapies research team, and by members of the RNOH Research & Innovation team.  
8.6 
Patient & Public Involvement 
 
A stated purpose of this study is to garner participant experience and opinion as to the acceptability of 
the research, in individual terms of benefits versus any negative issues such as comfort or practicality 
in daily activities, as well as general benefits to patients.  
Future study design will be informed by these findings. A summary of the study outcomes will be 
communicated to all study participants.  
8.7 
Protocol compliance 
 
Protocol deviations, non-compliances, or breaches are departures from the approved protocol.  

 
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Accidental protocol deviations can happen at any time. They must be adequately documented on the 
relevant forms and reported to the Chief Investigator and Sponsor immediately.  
Deviations from the protocol that are found to frequently recur are not acceptable, will require immediate 
action and could potentially be classified as a serious breach. 
Sponsor will be notified of any potential breaches of governance within 24 hours of occurrence, to ensure 
appropriate Corrective and Preventative Actions (CAPAs) are generated and further management and 
reporting are addressed in a timely manner.  
8.8 
Data protection and patient confidentiality 
  
All investigators and study site staff must comply with the requirements of the Data Protection Act 2018 
(UK implementation of the EU General Data Protection Regulation (GDPR)) with regards to the 
collection, storage, processing and disclosure of personal information and will uphold the Act’s core 
principles.  
The data will be generated within the RNOH clinical facility. The data will be analysed by the research 
team using Trust, protected computer systems. All databases used during the study will be on password 
and firewall protected, NHS Trust proprietary systems and private cloud channels accessible only the 
research team. No transfer of data to sponsors or external investigators will take place. 
Personal data will be stored and accessed for the limited period of maximum 12 months after the study 
has ended. Research data will be stored for 5 years after study conclusion. Research data will be stored 
on password protected Trust systems and accessible only by the research team. Where hard copy 
records or questionnaires are generated during the study, these will be scanned electronically and the 
hard copies will be destroyed. 
The study Sponsor is the custodian of study data and the PI will act as the data custodian until study 
completion. 
8.9 
Indemnity 
 
Royal National Orthopaedic Hospital NHS Trust is party to NHS Litigation Authority (NHSLA) / NHS 
Resolution. As an NHS body it is liable for clinical negligence and other negligent harm to individuals 
covered by their duty of care. NHS Institutions employing researchers are liable for negligent harm caused 
by the design of studies they initiate. 
8.10 
Access to the final study dataset 
 
Only the CI and PI will have access to the full study dataset. Site investigators will be able to access the 
full dataset if a formal request describing their plans is approved by the steering group. 
9. 
DISSEMINATION POLICY 
 
9.1 
Dissemination policy 
 
RNOH will own the data arising from the study. As current RNOH staff the investigators will retain the right 
to publish studies. On completion of the study, the data will be analysed and tabulated and a Final Study 
Report prepared. The study report will be made accessible on ClinicalTrials.gov.  
No funding or supporting body needs to be acknowledged within the publications and whether they have 
reviewed and publication rights of the data from the study. 
Participants will receive feedback of their individual results following the conclusion of the study. Following 
publication, all participants will receive a copy of the peer-reviewed article. 

 
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Participant may specifically request results from their PI and when would this information be provided after 
the results had been published. The study protocol, full study report, anonymised participant level dataset, 
and statistical code for generating the results will be made publicly available on request following publication 
in peer-reviewed journal(s). 
9.2 
Authorship eligibility guidelines and any intended use of professional writers 
 
The immediate research team will be granted authorship on the final study report. 
9.3 
Archiving Arrangements 
 
This is a single centre study and RNOH site will be responsible for their onsite level study archiving. The 
trial essential TMF along with any central trial database will be archived in accordance with the sponsor 
SOP for archiving arrangements.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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10. 
REFERENCES 
 
Chaléat-Valayer E, Denis A, Zelmar A, Pujol A, Bernadou A, Bard-Pondarré R, Touzet S. VETCOSED 
study: efficacy of compressive garments for patients with hypermobile Ehlers-Danlos syndrome on 
shoulder stability and muscles strength. Disabil Rehabil. 2022 Jun;44(13):3165-3172. doi: 
10.1080/09638288.2020.1860142. Epub 2020 Dec 22. PMID: 33353449.  
• Higo A, Pearec G, Palmer S, Grant L. The value of dynamic elastomeric fabric orthoses in the 
management of a complex hypermobile Ehlers-Danlos syndrome patient: A case report. Clin Case 
Rep. 2023;11:e06821. |1 of 7https://doi.org/10.1002/ccr3.6821  
• Jacobsen JS et. al Muscle-tendon-related pain in 100 patients with hip dysplasia: prevalence and 
associations with self-reported hip disability and muscle strength, Journal of Hip Preservation Surgery, 
Volume 5, Issue 1, January 2018, Pages 39–46  
• Ladurner et al 2021. Treatment of Gluteal Tendinopathy. A Systematic Review and Stage-Adjusted 
Treatment Recommendation. The Orthopaedic Journal of Sports Medicine, 9(7), 23259671211016850 
DOI: 10.1177/23259671211016850  
• Lewis CL, Khuu A, Marinko L. Postural correction reduces hip pain in adult with acetabular dysplasia: 
a case report. Man Ther. 2015;20(3):1-16.  
• Matthews M, Payne C, Watson M. The use of a dynamic elastomeric fabric orthosis to manage 
painful shoulder subluxation: a case study. J Prosthet Orthot. 2011;23:155-158.  
• Santore R, Gosey G, Muldoon M, Long A, Healey R. Hypermobility assessment in 1,004 adult 
patients presenting with hip pain. J Bone Joint Surg. 2020;102(2):27-33.  
• Smith TO, Jerman E, Easton EV, et al. Do people with benign joint hypermobility syndrome (BJHS) 
have reduced joint proprioception? A systematic review and meta-analysis. Rheumatol Int. 
2013;33:2709-2716.  
• Snowdon N, Sier D, Potia T, Wheat J, Mclean S. Compression garments and fabric orthoses for 
rehabilitation and function: A systematic mapping review. International Journal of Therapy and 
Rehabilitation. 2018. 25. 655-664. 10.12968/ijtr.2018.25.12.655.  
• Wilkin GP, Ibrahim MM, Smit KM, Beaulé PE. A contemporary definition of hip dysplasia and 
structural instability: toward a comprehensive classification for acetabular dysplasia. J Arthroplasty. 
2017;32(9 S):S20-S27. 
 
 

 
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11 
APPENDICES 
 
Appendix 1 – Amendment History 
 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made 
 
 
 
 
 
 
This table should be used for amendments submitted after initial REC/HRA approvals. List details of all 
protocol amendments here whenever a new version of the protocol is produced. 
Protocol amendments must be submitted to the Sponsor for approval prior to submission to the 
REC/HRA.