Dynamic Lycra Garments for Hip Dysplasia Feasibility Study (HIPlycra)

February 23, 2026 updated by: Katie Monnington, Royal National Orthopaedic Hospital NHS Trust

Dynamic Lycra Garments to Address Pain and Instability Associated With Hip Dysplasia: a Single Cohort Observational Pilot Study

Dynamic lycra garments are deployed in rehabilitation and exercise to support unstable areas of the body, enhance sensory feedback to improve movement patterns, reduce fatigue and pain and improve function.

2 case studies have respectively highlighted the effective use of postural correction to reduce hip pain in an adult with acetabular dysplasia while lycra orthoses have reduced pain and improved stability in the hip. Larger scale studies assessing the effect of lycra garments across a clinical population of those presenting with combined hypermobility and hip dysplasia are needed to investigate the extent of generalisable effects.

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?".

The intention of this single cohort, observational pilot is primarily to establish the feasibility of studying the effect of the garments and assess the justification for further quantitative study, rather than the adjunctive effect of the shorts themselves.

The investigators are aiming to recruit 8-10 participants who will form a single cohort for observation, with the aim of gathering chiefly qualitative outcomes. This feasibility study is not intended to be blinded.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The Royal National Orthopaedic Hospital (RNOH) Adult Hip service treats many patients with hypermobility and hip dysplasia, the burden of both conditions including joint pain and instability affecting function and quality of life. Evidence suggests a highly significant association between these conditions.

Dynamic lycra garments are deployed in rehabilitation and exercise to support unstable areas of the body, enhance sensory feedback to improve movement patterns, reduce fatigue and pain and improve function.

A high prevalence of hypermobility has been found in populations living with hip dysplasia. 2 case studies have respectively highlighted the effective use of postural correction to reduce hip pain in an adult with acetabular dysplasia while lycra orthoses have reduced pain and improved stability in the hip. Larger scale studies assessing the effect of lycra garments across a clinical population of those presenting with combined hypermobility and hip dysplasia are needed to investigate the extent of generalisable effects.

The research question underpinning the project is as follows,"Can the use of dynamic compression shorts during daily activities improve short term physiotherapy treatment outcomes in hip dysplasia patients?".

This single cohort observational 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 treatment period and assess the justification for further quantitative study, rather than the adjunctive effect of the shorts themselves.

The findings will inform the development of an interventional 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.

The investigators are aiming to recruit 8-10 participants with the aim of gathering chiefly qualitative outcomes. The research activities will be carried out within the Hip specialist clinic environment at the Trust Stanmore site. Prospective participants will be screened for inclusion by medical staff and then provided with a Patient Information Sheet (PIS), following which patients will be invited to a baseline measurement session with the research therapist. This feasibility study is not intended to be blinded and will be undertaken as an observational study of a single cohort.

The intervention, dynamic lycra shorts, are a Conformite Europeenne (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 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, Developmental Dysplasia of the Hip (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.

The study will aim to include all adult (18+) patients with capacity and who are not classified as vulnerable individuals, who are identified as falling within the spectrum of hypermobility using validated scoring scales, with hip dysplasia signs deemed suitable for conservative care by the RNOH Hip Service medical team, and who are not under other current or planned treatments within the study duration that could affect the study outcomes. Individuals with a history of hip surgery or trauma to the hip will aso be excluded.

No upper age limit is applied. Those with identified co-morbidity including age-related degenerative changes to the hip which may obscure the effects of interest in the study may be excluded where clearly justified.

It will be made plain that each participant is free to withdraw from the study at any time without the need to provide a reason.

At the medical interview, these individuals will be provided with an information sheet and invited to contact the research team to signal their informed consent to take part in the study.

As physical attendance is required at the baseline and follow up sessions, and following confirmatory screening participants will be able to read and sign the study consent form in the presence of the research therapist. Screening will include hypermobility scoring and questionnaire based assessment of anxiety or depression related to experience of the hip pathology. As anxiety and depression are thought to be significant confounding factors when measuring the subjective impact of surgical treatment interventions, participants will complete the Hip Anxiety and Depression Score (HADS). The investigators will, however, welcome those testing positive for these psychological factors to continue onto the study on the basis that there is no reason to believe that the effect of the proposed intervention will be different for such individuals and assessment of this factor could provide valuable information about both cofactors and treatment benefits in future study and treatment protocols.

This study is observational and will not require allocation to intervention groups.

The data for each participant will be pseudonymised by assigning an identifier code at the point of study inclusion. All information, including screening data and outcome scoring together with limited demographic information will be stored under the identifier code.

At the study conclusion each participant will be asked to complete an experience questionnaire and have the opportunity to receive a debrief of their personal study data. They will also be followed up with a questionnaire asking them to reflect upon their qualitative experience and perceived personal and generalisable benefits of current and planned research into such conservative therapies.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or over
  • Clinical diagnosis of Develomental Dysplasia of the Hip (DDH)
  • Clinical diagnosis of hypermobility

Exclusion Criteria:

  • Under 18 years of age
  • Clinical diagnosis of additional musculoskeletal pathology affecting hips or pelvis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All included participants

All screened patients will be invited to participate by the medical team, based upon the inclusion and exclusion criteria specified. If the patient agrees to attend, they will attend at the research site where the following activities will take place:

  1. baseline strength testing, questionnaires and interview completion.
  2. shorts measurement, standardised method.
  3. shorts can be fitted from stock provided by supplier (DMO Ltd).
  4. Orthosis and exercise education provided. Participants will be directed to wear the lycra shorts during all daily activity and physiotherapy exercise.

During the 8-12 week home trial period each participant will complete a formatted daily exercise and lycra garment intervention diary.

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
Device: Lycra Shorts
The intervention, dynamic lycra shorts, are a CE marked item which are marketed towards treating the symptoms of joint hypermobility amongst many other pathologies. The product is pre-made in 7 male and female sizes, are pulled on without zips or closures and have been designed to aid lower limb function and posture whilst increasing core and pelvic stability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Hip Outcome Tool (iHOT-12)
Time Frame: Between baseline and end of treatment at 12 weeks

The International Hip Outcome Tool (iHOT) was developed by Mohtadi et al as a means of assessing a patient's ability to return to an active lifestyle through obtaining subjective measures of symptoms, as well as determining emotional and social health status.

Results will be reported with the unabbreviated scale title, the minimum, median and maximum values, with higher scores meaning a better outcome. The scale is between 0-100 with 0 meaning a worst score and 100 the highest/best score
Between baseline and end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goal Attainment Scale (GAS)
Time Frame: Between baseline and end of treatment at 12 weeks.

The Goal Attainment Scale (GAS) is a method of scoring the extent to which patient"s individual goals are achieved in the course of intervention, to measure functional improvements that might not be captured by standard assessments. Unlike standardized tests, GAS allows patients to set their own, relevant goals, making it highly specific to their needs. In effect, each patient has their own outcome measure but this is scored in a standardised way as to allow statistical analysis.

For each goal, 0 is the baseline score, +2 is the highest score and -2 is the lowest score Results will be reported with the unabbreviated scale title, the minimum, median and maximum values, with higher scores meaning a better outcome.
Between baseline and end of treatment at 12 weeks.
Isometric hip muscle strength testing
Time Frame: Between baseline and end of treatment at 12 weeks

Hand-held dynamometry is a quantitative and accessible means of determining the isometric force of muscle groups. In the current context, objective and standardised measurement will allow for comparisons of condition against population norms and any changes over the duration of study.

Results will be reported with the unabbreviated scale title (Newtons), the minimum, median and maximum values, with higher scores meaning a better outcome.
Between baseline and end of treatment at 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orthotic and Prosthetic Users Survey (OPUS) Client Satisfaction with Device (CSD)scale module (Qs 1-9)
Time Frame: Measured at single time point: conclusion of study at 12 weeks

The Orthotic and Prosthetic Users Survey (OPUS) Client Satisfaction with Device (CSD) module is designed to measure a user's satisfaction with their prosthetic or orthotic device.

The 9-item version of the OPUS CSD is focused specifically on assessment of experience of the the device's functional and physical characteristics and is rated on a Likert scale (1-5) where higher score indicates greater satisfaction/agreement):
Measured at single time point: conclusion of study at 12 weeks
Orthotic and Prosthetic Users Survey (OPUS) Heath Quality of Life (HRQOL) STATUS
Time Frame: From baseline to the follow-up interval at 12 weeks
The Orthotics and Prosthetics Users' Survey (OPUS) Health-Related Quality of Life (HRQOL) index is a 23-item, validated self-report instrument designed to assess the quality of life for individuals using orthotic or prosthetic (O&P) devices. These cover physical, emotional, and social impacts of wearing a prosthetic or orthotic device, such as pain, restrictions in daily activities (hobbies, chores, work), social, and psychological interactions.The HRQOL uses a 5-level Likert scale (0-4) for its items. The raw aggregate score for the 23 items ranges from 0 to 92, with a higher total score indicating a better outcome (better quality of life).
From baseline to the follow-up interval at 12 weeks
Orthotic and Prosthetic Users Survey (OPUS) Lower Extremity Functional Status (LEFS)
Time Frame: From baseline to the follow-up interval at 12 weeks
The Orthotic and Prosthetic Users Survey (OPUS) Lower Extremity Functional Status (LEFS) is a patient-administered questionnaire designed to evaluate functional mobility in individuals with lower limb orthoses or prostheses. The survey contains 20 items, each scored on a 5-point ordinal scale ranging from 0 (cannot do) to 4 (no difficulty), for a total raw score of up to 80. It measures the difficulty of daily tasks, with higher scores indicating better functional ability.
From baseline to the follow-up interval at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal National Orthopaedic Hospital NHS Trust

Investigators

  • Principal Investigator: Katie Monnington, BSc, Royal National Orthopaedic Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 3, 2026

Primary Completion (Estimated)

September 8, 2027

Study Completion (Estimated)

September 8, 2027

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNOH-342748

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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