N/A
N=11
Investigating the Clinical and Cost Effectiveness of Lycra Splinting
Learning Disability
Bottom Line
View on ClinicalTrials.gov: NCT02345512 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Falls — 3 Falls
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lycra Splinting Garment (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Glasgow Caledonian University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Falls |
3 | — |
| PRIMARY Center of Pressure Standard Deviation |
10.6; 9.8 | — |
| PRIMARY Walking Speed |
0.593; 0.594 | — |
| PRIMARY Step Length |
0.402; 0.398 | — |
| PRIMARY Base of Support |
0.187; 0.196 | — |
| PRIMARY Step Symmetry |
0.86; 0.86 | — |
| PRIMARY Double Support Time as a Percentage of the Gait Cycle |
56.30; 55.80 | — |
| PRIMARY Timed Up and Go Test Time |
20.68; 19.71 | — |
| SECONDARY Number of Participants That Were Compliant With Lycra Splinting Garment Wear |
9 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT02345512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.