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临床试验/NCT02345512
NCT02345512已完成不适用

Investigation of Lycra Splinting Garments for Falls and Intellectual Disabilities

Glasgow Caledonian University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Timed Up and Go Test Time

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant has a learning disability, and has had a fall within the last 12 months due to a balance or gait issue.

排除标准

  • Any participant who does not have capacity to consent.

结局指标

主要结局

Timed Up and Go Test Time

时间窗: 6 week intervention period

The time taken to complete the Timed Up and Go Test.

Base of Support

时间窗: 6 week intervention period

Width between heel strikes perpendicular to direction of travel

Step Symmetry

时间窗: 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.

Falls

时间窗: 6 weeks

Self-report fall calendar completed daily during the 6-week intervention period

Double Support Time as a Percentage of the Gait Cycle

时间窗: 6 week intervention period

Percentage of the gait cycle where both feet are on the ground together.

Center of Pressure Standard Deviation

时间窗: 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

时间窗: 6 week intervention period

The walking speed along a standardised walking mat.

Step Length

时间窗: 6 week intervention period

Distance from initial foot contact on one side to initial foot contact on contralateral side.

次要结局

  • Number of Participants That Were Compliant With Lycra Splinting Garment Wear(6 week intervention period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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