Learning Disability
Conditions
Keywords
Falls
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.
Interventions
DEVICELycra Splinting Garment
Wearing of lycra splinting garment for 6 weeks
Sponsors
NHS Greater Glasgow and Clyde
Chief Scientist Office of the Scottish Government
Glasgow Caledonian University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go Test Time | 6 week intervention period | The time taken to complete the Timed Up and Go Test. |
| Step Length | 6 week intervention period | Distance from initial foot contact on one side to initial foot contact on contralateral side. |
| Base of Support | 6 week intervention period | Width between heel strikes perpendicular to direction of travel |
| Falls | 6 weeks | Self-report fall calendar completed daily during the 6-week intervention period |
| Center of Pressure Standard Deviation | 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 | 6 week intervention period | The walking speed along a standardised walking mat. |
| Step Symmetry | 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 | 6 week intervention period | Percentage of the gait cycle where both feet are on the ground together. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Were Compliant With Lycra Splinting Garment Wear | 6 week intervention period | Survey questions to determine usability (compliance) of lycra splinting garment wear for individuals with intellectual disabilities |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited via the National Health service physiotherapists in 2 Health Boards.
Participants by arm
| Arm | Count |
|---|---|
| Lycra Splint Wearing of Lycra splinting garment
Lycra Splinting Garment: Wearing of lycra splinting garment for 6 weeks | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lycra Splint |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Region of Enrollment United Kingdom | 11 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Base of Support
Width between heel strikes perpendicular to direction of travel
Time frame: 6 week intervention period
Population: Adults with Intellectual Disabilities with Gait or Balance Issues who Fall
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Base of Support | 0.187 m |
| Post Intervention | Base of Support | 0.196 m |
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.
Time frame: 6 week intervention period
Population: Adults with intellectual disabilities with gait or balance issues who have experienced a fall in previous 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Center of Pressure Standard Deviation | 10.6 mm |
| Post Intervention | Center of Pressure Standard Deviation | 9.8 mm |
Primary
Double Support Time as a Percentage of the Gait Cycle
Percentage of the gait cycle where both feet are on the ground together.
Time frame: 6 week intervention period
Population: Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Double Support Time as a Percentage of the Gait Cycle | 56.30 percentage of the gait cycle |
| Post Intervention | Double Support Time as a Percentage of the Gait Cycle | 55.80 percentage of the gait cycle |
Primary
Falls
Self-report fall calendar completed daily during the 6-week intervention period
Time frame: 6 weeks
Population: Adults with Intellectual Disabilities with gait issues who experienced a fall within the last 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Falls | 3 Falls |
Primary
Step Length
Distance from initial foot contact on one side to initial foot contact on contralateral side.
Time frame: 6 week intervention period
Population: Adults with intellectual disabilities with gait or balance issues who have fallen in previous 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Step Length | 0.402 m |
| Post Intervention | Step Length | 0.398 m |
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.
Time frame: 6 week intervention period
Population: Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Step Symmetry | 0.86 ratio |
| Post Intervention | Step Symmetry | 0.86 ratio |
Primary
Timed Up and Go Test Time
The time taken to complete the Timed Up and Go Test.
Time frame: 6 week intervention period
Population: Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Timed Up and Go Test Time | 20.68 s |
| Post Intervention | Timed Up and Go Test Time | 19.71 s |
Primary
Walking Speed
The walking speed along a standardised walking mat.
Time frame: 6 week intervention period
Population: Adults with intellectual disabilities with balance or gait issues who fall
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Walking Speed | 0.593 m/s |
| Post Intervention | Walking Speed | 0.594 m/s |
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
Time frame: 6 week intervention period
Population: adults with intellectual disabilities who had experienced a fall in the last 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Participants That Were Compliant With Lycra Splinting Garment Wear | 9 participants |