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Investigating the Clinical and Cost Effectiveness of Lycra Splinting

Not Applicable
Completed
Conditions
Learning Disability
Interventions
Device: Lycra Splinting Garment
Registration Number
NCT02345512
Lead Sponsor
Glasgow Caledonian University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
11
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
FallsLycra Splinting GarmentWearing of Lycra splinting garment
Primary Outcome Measures
NameTimeMethod
Timed Up and Go Test Time6 week intervention period

The time taken to complete the Timed Up and Go Test.

Base of Support6 week intervention period

Width between heel strikes perpendicular to direction of travel

Step Symmetry6 week intervention period

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.

Falls6 weeks

Self-report fall calendar completed daily during the 6-week intervention period

Double Support Time as a Percentage of the Gait Cycle6 week intervention period

Percentage of the gait cycle where both feet are on the ground together.

Center of Pressure Standard Deviation6 week intervention period

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.

Walking Speed6 week intervention period

The walking speed along a standardised walking mat.

Step Length6 week intervention period

Distance from initial foot contact on one side to initial foot contact on contralateral side.

Secondary Outcome Measures
NameTimeMethod
Number of Participants That Were Compliant With Lycra Splinting Garment Wear6 week intervention period

Survey questions to determine usability (compliance) of lycra splinting garment wear for individuals with intellectual disabilities

Trial Locations

Locations (1)

Glasgow Caledonian University

🇬🇧

Glasgow, Scotland, United Kingdom

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