Investigating the Clinical and Cost Effectiveness of Lycra Splinting

Study Overview
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Brief Summary
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People with learning disabilities (LDs) experience high levels of health problems, including cerebral palsy, other problems associated with posture, movement and function, and injury (falls are the commonest cause of injury in this population, and poor balance/coordination are a contributory factor). The aim of this project is to investigate the clinical and cost effectiveness of lycra splinting garments (LSGs), worn to improve posture, movement and function, for adults (16 years and over) with LDs who fall. This project aims to investigate the clinical and cost effectiveness of LSGs to prevent future falls of adults with LDs, to inform practice and guidelines within local and national (National Health Service - NHS) adult services. Falls and fall injury are a serious problem for people with LDs (people with LDs experience similar rates of falls as the elderly in the general population but at a younger age), whereby interventions are warranted. Lab based 3D movement analysis will be conducted with adults with LDs who fall during two visits to perform simple tasks (e.g. walking) (once prior to being provided with LSG, and once 6 weeks after wearing the LSGs at home).

Detailed Description
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Adults with Learning Disability who have capacity will be recruited to participate in the Lycra splinting trial via their local physiotherapist. The eligibility criteria is an adult with Learning Disability who has had a fall and who has problems with their balance and/or gait as identified by their local physiotherapist. The participants will be recruited via participant information sheets. The participants will attend the Glasgow Caledonian University (GCU) gait laboratory to undertake three-dimensional movement analysis; Gaitrite test (the Gaitrite is a commercially available instrumented walkway); and Centre of Pressure testing. This will take place before prescription of a Lycra splinting garment and a minimum of 6 weeks wear after receiving a Lycra splinting garment. Analysis of data captured before and after wearing the Lycra splinting garment will take place. The use-ability of the Lycra splinting garment will also be determined by completion of a user and carer questionnaire and by completion of a questionnaire by their local physiotherapist. The cost effectiveness of Lycra splinting garments will be analysed by a health statistician within GCU.

Official Title
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Investigation of Lycra Splinting Garments for Falls and Intellectual Disabilities

Conditions
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Learning Disability

Intervention / Treatment
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* Device: Lycra Splinting Garment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has a learning disability, and has had a fall within the last 12 months due to a balance or gait issue. Exclusion Criteria: Any participant who does not have capacity to consent.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Falls<br>Wearing of Lycra splinting garment | Device: Lycra Splinting Garment<br>* Wearing of lycra splinting garment for 6 weeks<br>* Other names: Dynamic Elastomeric Functional Orthosis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls | Self-report fall calendar completed daily during the 6-week intervention period | 6 weeks | 
| Center of Pressure Standard Deviation | The standard deviation of the Center of Pressure during quiet standing. The standard deviation of this measure is used as the outcome as it is the dispersion of the location of the centre of pressure that is of interest. | 6 week intervention period | 
| Walking Speed | The walking speed along a standardised walking mat. | 6 week intervention period | 
| Step Length | Distance from initial foot contact on one side to initial foot contact on contralateral side. | 6 week intervention period | 
| Base of Support | Width between heel strikes perpendicular to direction of travel | 6 week intervention period | 
| Step Symmetry | The symmetry was calculated as the ratio between the longest and shortest of the left and right step lengths. This provides an indication of the level of symmetry between sides. A score of 1 indicates complete symmetry with values less than one becoming progressively less symmetrical. | 6 week intervention period | 
| Double Support Time as a Percentage of the Gait Cycle | Percentage of the gait cycle where both feet are on the ground together. | 6 week intervention period | 
| Timed Up and Go Test Time | The time taken to complete the Timed Up and Go Test. | 6 week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Were Compliant With Lycra Splinting Garment Wear | Survey questions to determine usability (compliance) of lycra splinting garment wear for individuals with intellectual disabilities | 6 week intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Falls