Investigating the Clinical and Cost Effectiveness of Lycra Splinting

April 9, 2020 updated by: Glasgow Caledonian University

Investigation of Lycra Splinting Garments for Falls and Intellectual Disabilities

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G4 0BA
        • Glasgow Caledonian University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Falls
Wearing of Lycra splinting garment
Device: Lycra Splinting Garment
Wearing of lycra splinting garment for 6 weeks
Other Names:
  • Dynamic Elastomeric Functional Orthosis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glasgow Caledonian University

Collaborators

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

Investigators

  • Study Chair: Janet Finlayson, PHD, Glasgow Caledonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 20, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GlasgowCULycraTrial01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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