Dynamic Lycra Garments for Hip Dysplasia Feasibility Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal National Orthopaedic Hospital NHS Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or over

Clinical diagnosis of Develomental Dysplasia of the Hip (DDH)

Clinical diagnosis of hypermobility

Disqualifiers

Under 18 years of age

Clinical diagnosis of additional musculoskeletal pathology affecting hips or pelvis

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: All included participantsOther 1 intervention

Trial outcomes

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

Time frame
Between baseline and end of treatment at 12 weeks

Secondary outcomes

1

Goal Attainment Scale (GAS)

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.

Time frame
Between baseline and end of treatment at 12 weeks.
2

Isometric hip muscle strength testing

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.

Time frame
Between baseline and end of treatment at 12 weeks

Other outcomes

1

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

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):

Time frame
Measured at single time point: conclusion of study at 12 weeks
2

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

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).

Time frame
From baseline to the follow-up interval at 12 weeks
3

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

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.

Time frame
From baseline to the follow-up interval at 12 weeks

Locations

This trial has no locations.

Sponsors and contacts

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