Learning DisabilityNCT02345512
Investigating the Clinical and Cost Effectiveness of Lycra Splinting
A study testing Lycra Splinting Garment in people with Learning Disability, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Learning Disability
- What is being tested?
- Lycra Splinting Garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participant has a learning disability, and has had a fall within the last 12 months due to a balance or gait issue.
Who cannot join
- Any participant who does not have capacity to consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Caledonian University
Glasgow, Scotland, G4 0BA
About this study
Official title: 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).
Read the 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.
- Conditions
- Learning Disability
- Being tested
- Lycra Splinting Garment
- Keywords
- Falls
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lycra Splinting GarmentDevice
Also called Dynamic Elastomeric Functional Orthosis
Wearing of lycra splinting garment for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Falls | Other | Wearing of Lycra splinting garment Receives: Device: Lycra Splinting Garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls
Self-report fall calendar completed daily during the 6-week intervention period
Measured: 6 weeks
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.
Measured: 6 week intervention period
Walking Speed
The walking speed along a standardised walking mat.
Measured: 6 week intervention period
Step Length
Distance from initial foot contact on one side to initial foot contact on contralateral side.
Measured: 6 week intervention period
Base of Support
Width between heel strikes perpendicular to direction of travel
Measured: 6 week intervention period
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.
Measured: 6 week intervention period
Double Support Time as a Percentage of the Gait Cycle
Percentage of the gait cycle where both feet are on the ground together.
Measured: 6 week intervention period
Timed Up and Go Test Time
The time taken to complete the Timed Up and Go Test.
Measured: 6 week intervention period
Secondary outcomes (1)
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
Measured: 6 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Learning DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, Chief Scientist Office of the Scottish Government
- Responsible party
- Sponsor
- Investigators
- Janet Finlayson, PHD, Study chair, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345512
- Sponsor's protocol ID
- GlasgowCULycraTrial01
- Status last verified
- Feb 2018
- First submitted
- 20 Jan 2015
- Last updated
- 24 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29441642
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Lycra Splinting Garments for Falls and Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT02345512
- Acronym / sponsor ID
- GlasgowCULycraTrial01
- Conditions
- Learning Disability
- Keywords
- Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, Chief Scientist Office of the Scottish Government
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Falls | Other | Device: Lycra Splinting GarmentWearing of Lycra splinting garment |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participant has a learning disability, and has had a fall within the last 12 months due to a balance or gait issue.
Key exclusion criteria (1 listed)
- Any participant who does not have capacity to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lycra Splinting GarmentAlso: Dynamic Elastomeric Functional OrthosisWearing of lycra splinting garment for 6 weeks | Device | Falls |
Primary outcome
Falls
Time frame: 6 weeks
Self-report fall calendar completed daily during the 6-week intervention period
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.
Walking Speed
Time frame: 6 week intervention period
The walking speed along a standardised walking mat.
Step Length
Time frame: 6 week intervention period
Distance from initial foot contact on one side to initial foot contact on contralateral side.
Base of Support
Time frame: 6 week intervention period
Width between heel strikes perpendicular to direction of travel
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.
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.
Timed Up and Go Test Time
Time frame: 6 week intervention period
The time taken to complete the Timed Up and Go Test.
1 secondary outcome
Number of Participants That Were Compliant With Lycra Splinting Garment Wear
Time frame: 6 week intervention period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29441642Finlayson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Finlayson, PHD study chair
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lycra Splinting Garment in people with Learning Disability, run by Glasgow Caledonian University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls (time frame: 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02345512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.