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| Name | Class |
|---|---|
| NHS Greater Glasgow and Clyde | OTHER |
| Chief Scientist Office of the Scottish Government | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Falls | Other | Wearing of Lycra splinting garment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lycra Splinting Garment | Device | Wearing of lycra splinting garment for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Falls | Self-report fall calendar completed daily during the 6-week intervention period | 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. | 6 week intervention period |
| Walking Speed | The walking speed along a standardised walking mat. | 6 week intervention period |
| Step Length | Distance from initial foot contact on one side to initial foot contact on contralateral side. | 6 week intervention period |
| Base of Support | Width between heel strikes perpendicular to direction of travel | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 week intervention period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Finlayson, PHD | Glasgow Caledonian University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glasgow Caledonian University | Glasgow | Scotland | G4 0BA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29441642 | Result | 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. |
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Participants were recruited via the National Health service physiotherapists in 2 Health Boards.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lycra Splint | Wearing of Lycra splinting garment Lycra Splinting Garment: Wearing of lycra splinting garment for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Adults with Intellectual Disabilities
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| ID | Title | Description |
|---|---|---|
| BG000 | Lycra Splint | Wearing of Lycra splinting garment Lycra Splinting Garment: Wearing of lycra splinting garment for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Falls | Self-report fall calendar completed daily during the 6-week intervention period | Adults with Intellectual Disabilities with gait issues who experienced a fall within the last 12 months | Posted | Mean | Full Range | Falls | 6 weeks |
|
|
Adverse event data was collected over the study data collection period which was 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lycra Splint | Wearing of Lycra splinting garment Lycra Splinting Garment: Wearing of lycra splinting garment for 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment | bruising to buttock area following assistance of putting on Lycra splinting garment. |
Small participant numbers did not allow for inferential statistics
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms Jennifer Crockett | National Health Service Greater Glasgow & Clyde | 0141 276 4900 | 4912 | jennifer.crockett@ggc.scot.nhs.uk |
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| ID | Term |
|---|---|
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 6 week intervention period |
| Timed Up and Go Test Time | The time taken to complete the Timed Up and Go Test. | 6 week intervention period |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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. | Adults with intellectual disabilities with gait or balance issues who have experienced a fall in previous 12 months | Posted | Mean | Full Range | mm | 6 week intervention period |
|
|
|
| Primary | Walking Speed | The walking speed along a standardised walking mat. | Adults with intellectual disabilities with balance or gait issues who fall | Posted | Mean | Full Range | m/s | 6 week intervention period |
|
|
|
| Primary | Step Length | Distance from initial foot contact on one side to initial foot contact on contralateral side. | Adults with intellectual disabilities with gait or balance issues who have fallen in previous 12 months | Posted | Mean | Full Range | m | 6 week intervention period |
|
|
|
| Primary | Base of Support | Width between heel strikes perpendicular to direction of travel | Adults with Intellectual Disabilities with Gait or Balance Issues who Fall | Posted | Mean | Full Range | m | 6 week intervention period |
|
|
|
| Primary | 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. | Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months | Posted | Mean | Full Range | ratio | 6 week intervention period |
|
|
|
| Primary | Double Support Time as a Percentage of the Gait Cycle | Percentage of the gait cycle where both feet are on the ground together. | Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months | Posted | Mean | Full Range | percentage of the gait cycle | 6 week intervention period |
|
|
|
| Primary | Timed Up and Go Test Time | The time taken to complete the Timed Up and Go Test. | Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months | Posted | Mean | Full Range | s | 6 week intervention period |
|
|
|
| Secondary | 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 | adults with intellectual disabilities who had experienced a fall in the last 12 months | Posted | Number | participants | 6 week intervention period |
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| 0 |
| 11 |
| 1 |
| 11 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |