Investigating the Clinical and Cost Effectiveness of Lycra Splinting
Investigation of Lycra Splinting Garments for Falls and Intellectual Disabilities
1 other identifier
interventional
11
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 20, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
April 7, 2020
CompletedApril 24, 2020
February 1, 2018
1.1 years
January 20, 2015
May 25, 2016
April 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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 Outcomes (1)
Number of Participants That Were Compliant With Lycra Splinting Garment Wear
6 week intervention period
Study Arms (1)
Falls
OTHERWearing of Lycra splinting garment
Interventions
Wearing of lycra splinting garment for 6 weeks
Eligibility Criteria
You may qualify if:
- Participant has a learning disability, and has had a fall within the last 12 months due to a balance or gait issue.
You may not qualify if:
- Any participant who does not have capacity to consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glasgow Caledonian Universitylead
- NHS Greater Glasgow and Clydecollaborator
- Chief Scientist Office of the Scottish Governmentcollaborator
Study Sites (1)
Glasgow Caledonian University
Glasgow, Scotland, G4 0BA, United Kingdom
Related 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. Epub 2018 Feb 14.
PMID: 29441642RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Small participant numbers did not allow for inferential statistics
Results Point of Contact
- Title
- Ms Jennifer Crockett
- Organization
- National Health Service Greater Glasgow & Clyde
Study Officials
- STUDY CHAIR
Janet Finlayson, PHD
Glasgow Caledonian University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2015
First Posted
January 26, 2015
Study Start
January 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 24, 2020
Results First Posted
April 7, 2020
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share