Clinical trial NCT02345512: Investigating the Clinical and Cost Effectiveness of Lycra Splinting
Official title: Investigation of Lycra Splinting Garments for Falls and Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Learning Disability
Keywords: Falls
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde
name: Chief Scientist Office of the Scottish Government
First posted: 2015-01-26
Enrollment: 11
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Falls
timeFrame: 6 weeks
measure: Center of Pressure Standard Deviation
timeFrame: 6 week intervention period
measure: Walking Speed
timeFrame: 6 week intervention period
measure: Step Length
timeFrame: 6 week intervention period
measure: Base of Support
timeFrame: 6 week intervention period
measure: Step Symmetry
timeFrame: 6 week intervention period
measure: Double Support Time as a Percentage of the Gait Cycle
timeFrame: 6 week intervention period
measure: Timed Up and Go Test Time
timeFrame: 6 week intervention period
Secondary outcomes:
measure: Number of Participants That Were Compliant With Lycra Splinting Garment Wear
timeFrame: 6 week intervention period
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
state: Scotland
Study officials:
affiliation: Glasgow Caledonian University
name: Janet Finlayson, PHD
role: STUDY_CHAIR
References:
citation: 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.