Dynamic Lycra Garments for Hip Dysplasia Feasibility Study

NCT07438873 | Not Yet Recruiting

• 1 other identifier: RNOH-342748
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hip Dysplasia; Hypermobility Syndrome

Keywords

Hypermobility; Orthotic; Hip dysplasia; Physiotherapy; Lycra; Dynamic lycra garments

Outcome Measures

Primary Outcomes (1)

• International Hip Outcome Tool (iHOT-12)

  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 Outcomes (2)

• Goal Attainment Scale (GAS)

  Between baseline and end of treatment at 12 weeks.

• Isometric hip muscle strength testing

  Between baseline and end of treatment at 12 weeks

Other Outcomes (3)

• Orthotic and Prosthetic Users Survey (OPUS) Client Satisfaction with Device (CSD)scale module (Qs 1-9)

  Measured at single time point: conclusion of study at 12 weeks

• Orthotic and Prosthetic Users Survey (OPUS) Heath Quality of Life (HRQOL) STATUS

  From baseline to the follow-up interval at 12 weeks

• Orthotic and Prosthetic Users Survey (OPUS) Lower Extremity Functional Status (LEFS)

  From baseline to the follow-up interval at 12 weeks

Study Arms (1)

All included participants

OTHER

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

Interventions

Lycra Shorts DEVICE

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.

All included participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Royal National Orthopaedic Hospital NHS Trust: lead

Related Publications (5)

• Higo A, Pearce 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 Jan 16;11(1):e6821. doi: 10.1002/ccr3.6821. eCollection 2023 Jan.

  PMID: 36694653 BACKGROUND

• Lewis CL, Khuu A, Marinko LN. Postural correction reduces hip pain in adult with acetabular dysplasia: A case report. Man Ther. 2015 Jun;20(3):508-12. doi: 10.1016/j.math.2015.01.014. Epub 2015 Feb 4.

  PMID: 25731688 BACKGROUND

• Santore RF, Gosey GM, Muldoon MP, Long AA, Healey RM. Hypermobility Assessment in 1,004 Adult Patients Presenting with Hip Pain: Correlation with Diagnoses and Demographics. J Bone Joint Surg Am. 2020 Nov 4;102(Suppl 2):27-33. doi: 10.2106/JBJS.20.00060.

  PMID: 32890043 BACKGROUND

• Finlayson J, Crockett J, Shanmugam S, Stansfield B. Lycra splinting garments for adults with intellectual disabilities who fall due to gait or balance issues: a feasibility study. J Intellect Disabil Res. 2018 May;62(5):391-406. doi: 10.1111/jir.12477. Epub 2018 Feb 14.

  PMID: 29441642 BACKGROUND

• 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. DOI: 10.12968/ijtr.2018.25.12.655.

  BACKGROUND

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• Katie Monnington, BSc

  Royal National Orthopaedic Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Ajraam, BSc

CONTACT

020 8909 5825; rnoh.research@nhs.net

Jim Ashworth-Beaumont, PhD

CONTACT

07985552258; jim.ashworth-beaumont@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Katie Monnington, Advanced Physiotherapy Practitioner, Principal Investigator, Hip Services, Royal National Orthopaedic Hospital NHS Trust

Model Details: All participants will undergo the following activities and exposures Following this, 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. Intervention window 8-12 weeks. Exercise prescription and adjunctive lycra shorts worn during all exercises and daily activities. 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 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.

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: February 27, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): September 8, 2027
• Study Completion (Estimated): September 8, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share