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Completed

NCT Number: NCT02345512

Investigating the Clinical and Cost Effectiveness of Lycra Splinting

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).

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Key information

Conditions

Learning Disability Communication Disorders Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glasgow Caledonian University

Glasgow, Scotland, G4 0BA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lycra Splinting Garment

Device

Wearing of lycra splinting garment for 6 weeks

Other names: Dynamic Elastomeric Functional Orthosis

Primary outcomes

  1. Falls

    Time frame: 6 weeks

    Self-report fall calendar completed daily during the 6-week intervention period

  2. Center of Pressure Standard Deviation

    Time frame: 6 week intervention period

    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.

  3. Walking Speed

    Time frame: 6 week intervention period

    The walking speed along a standardised walking mat.

  4. Step Length

    Time frame: 6 week intervention period

    Distance from initial foot contact on one side to initial foot contact on contralateral side.

  5. Base of Support

    Time frame: 6 week intervention period

    Width between heel strikes perpendicular to direction of travel

  6. Step Symmetry

    Time frame: 6 week intervention period

    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.

  7. Double Support Time as a Percentage of the Gait Cycle

    Time frame: 6 week intervention period

    Percentage of the gait cycle where both feet are on the ground together.

  8. Timed Up and Go Test Time

    Time frame: 6 week intervention period

    The time taken to complete the Timed Up and Go Test.

Secondary outcomes

  1. Number of Participants That Were Compliant With Lycra Splinting Garment Wear

    Time frame: 6 week intervention period

    Survey questions to determine usability (compliance) of lycra splinting garment wear for individuals with intellectual disabilities

Sponsors and collaborators

Lead sponsor

Glasgow Caledonian University

Other

Collaborators

  • Chief Scientist Office of the Scottish Government
  • NHS Greater Glasgow and Clyde

Registry information

Official study title

Investigation of Lycra Splinting Garments for Falls and Intellectual Disabilities

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2015
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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