This trial is active, not recruiting.

Condition learning disability
Treatment lycra splinting garment
Sponsor Glasgow Caledonian University
Collaborator NHS Greater Glasgow and Clyde
Start date January 2015
End date February 2016
Trial size 20 participants
Trial identifier NCT02345512, GlasgowCULycraTrial01


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 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. Labbased 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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Wearing of Lycra splinting garment
lycra splinting garment Dynamic Elastomeric Functional Orthosis
Wearing of lycra splinting garment for 6 weeks

Primary Outcomes

Objective measures of gait and balance using gait laboratory.
time frame: 6 weeks wear of lycra garment before and after testing.

Secondary Outcomes

usability of lycra splinting garment by carer and user questionnaire and questionnaire to local physiotherapist.
time frame: following 6 weeks of lycra wear

Eligibility Criteria

Male or female participants at least 16 years old.

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.

Additional Information

Official title Investigation of Lycra Splinting Garments for Falls and Intellectual Disabilities
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 3D movement analysis; Gaitrite test; and Central 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 useability 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 vis a health statistician within GCU.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Glasgow Caledonian University.