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Investigating the Clinical and Cost Effectiveness of Lycra Splinting

Primary Purpose

Learning Disability

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lycra Splinting Garment
Sponsored by
Glasgow Caledonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Learning Disability focused on measuring Falls

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Glasgow Caledonian University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Falls

Arm Description

Wearing of Lycra splinting garment

Outcomes

Primary Outcome Measures

Falls
Self-report fall calendar completed daily during the 6-week intervention period
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.
Walking Speed
The walking speed along a standardised walking mat.
Step Length
Distance from initial foot contact on one side to initial foot contact on contralateral side.
Base of Support
Width between heel strikes perpendicular to direction of travel
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.
Double Support Time as a Percentage of the Gait Cycle
Percentage of the gait cycle where both feet are on the ground together.
Timed Up and Go Test Time
The time taken to complete the Timed Up and Go Test.

Secondary Outcome Measures

Number of Participants That Were Compliant With Lycra Splinting Garment Wear
Survey questions to determine usability (compliance) of lycra splinting garment wear for individuals with intellectual disabilities

Full Information

First Posted
January 20, 2015
Last Updated
April 9, 2020
Sponsor
Glasgow Caledonian University
Collaborators
NHS Greater Glasgow and Clyde, Chief Scientist Office of the Scottish Government
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1. Study Identification

Unique Protocol Identification Number
NCT02345512
Brief Title
Investigating the Clinical and Cost Effectiveness of Lycra Splinting
Official Title
Investigation of Lycra Splinting Garments for Falls and Intellectual Disabilities
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glasgow Caledonian University
Collaborators
NHS Greater Glasgow and Clyde, Chief Scientist Office of the Scottish Government

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Learning Disability
Keywords
Falls

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Falls
Arm Type
Other
Arm Description
Wearing of Lycra splinting garment
Intervention Type
Device
Intervention Name(s)
Lycra Splinting Garment
Other Intervention Name(s)
Dynamic Elastomeric Functional Orthosis
Intervention Description
Wearing of lycra splinting garment for 6 weeks
Primary Outcome Measure Information:
Title
Falls
Description
Self-report fall calendar completed daily during the 6-week intervention period
Time Frame
6 weeks
Title
Center of Pressure Standard Deviation
Description
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.
Time Frame
6 week intervention period
Title
Walking Speed
Description
The walking speed along a standardised walking mat.
Time Frame
6 week intervention period
Title
Step Length
Description
Distance from initial foot contact on one side to initial foot contact on contralateral side.
Time Frame
6 week intervention period
Title
Base of Support
Description
Width between heel strikes perpendicular to direction of travel
Time Frame
6 week intervention period
Title
Step Symmetry
Description
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.
Time Frame
6 week intervention period
Title
Double Support Time as a Percentage of the Gait Cycle
Description
Percentage of the gait cycle where both feet are on the ground together.
Time Frame
6 week intervention period
Title
Timed Up and Go Test Time
Description
The time taken to complete the Timed Up and Go Test.
Time Frame
6 week intervention period
Secondary Outcome Measure Information:
Title
Number of Participants That Were Compliant With Lycra Splinting Garment Wear
Description
Survey questions to determine usability (compliance) of lycra splinting garment wear for individuals with intellectual disabilities
Time Frame
6 week intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Finlayson, PHD
Organizational Affiliation
Glasgow Caledonian University
Official's Role
Study Chair
Facility Information:
Facility Name
Glasgow Caledonian University
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0BA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29441642
Citation
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.
Results Reference
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Investigating the Clinical and Cost Effectiveness of Lycra Splinting

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