Investigating the Clinical and Cost Effectiveness of Lycra Splinting

Learning Disability Clinical Trial

Official title:

Investigation of Lycra Splinting Garments for Falls and Intellectual Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345512
• Other study ID #: GlasgowCULycraTrial01
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2018
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Learning Disability
• Learning Disorders

Intervention

Device:
• Lycra Splinting Garment
Wearing of lycra splinting garment for 6 weeks

Locations

Country	Name	City	State
United Kingdom	Glasgow Caledonian University	Glasgow	Scotland

Sponsors (3)

Lead Sponsor	Collaborator
Glasgow Caledonian University	Chief Scientist Office of the Scottish Government, NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls	Self-report fall calendar completed daily during the 6-week intervention period	6 weeks
Primary	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
Primary	Walking Speed	The walking speed along a standardised walking mat.	6 week intervention period
Primary	Step Length	Distance from initial foot contact on one side to initial foot contact on contralateral side.	6 week intervention period
Primary	Base of Support	Width between heel strikes perpendicular to direction of travel	6 week intervention period
Primary	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
Primary	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
Primary	Timed Up and Go Test Time	The time taken to complete the Timed Up and Go Test.	6 week intervention period
Secondary	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