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临床试验/NCT03295630
NCT03295630已完成不适用

Criterion Validity of the Actigraph GT3X Accelerometer in Determination of Body Position and Walking in Hospital Ward Patients Recovering From Critical Illness

Hull University Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Ability of an Accelerometer to Identify Step Count

研究概览

简要总结

This study will determine whether an Actigraph GT3X accelerometer can identify body position and quantify step count in a ward based population recovering from critical illness.

详细描述

Ward based patients recovering from critical illness who satisfy the inclusion criteria will have an Actigraph GT3X accelerometer positioned on the thigh and ankle of the non dominant leg. These will be used as an objective method of identifying adoption of lying, sitting and standing postures and quantification of step count. Both placement sites will be investigated in isolation. A further analysis will be undertaken to determine whether combining data from both placement sites (ankle and thigh) is superior in identification of lying, sitting and standing postures compared to an isolated single site. Accelerometer data will be compared against direct observation as the criterion measure.

Patients will undertake a semi-structured movement protocol consisting of typical activities undertaken by this population. These include lying in bed, transferring over the side of the bed, sit to stand postural transfers (and the reverse), sitting in a chair and walking. Observation periods will not exceed 3 hours. During this time all aspects of the movement protocol will be completed.

The data from this study will be analysed to determine the validity of the Actigraph GT3X in identification of body position and quantification of step count using the placement sites described above.

研究设计

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

入排标准

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

入选标准

  • •1 18 years of age or above.
  • •Ventilated in excess of 48 hours during admission in the Intensive Care Unit (ICU).
  • •Currently resident on a hospital ward (secondary care) following step down from ICU
  • •Able to undertake all postural transfers independently or with minimal assistance (one person only).
  • •Able to mobilise short distances, either independently or with assistance from a walking aid or one person.
  • •Willing to permit application of two Actigraph GT3X accelerometers Each device weighs 27g with dimensions of 3.8cm x 3.7cm x 1.8cm.
  • •Willing to consent to a period of direct observation for a length of time not exceeding three hours.

排除标准

  • •Unable to provide informed written consent themselves
  • •Unwilling to consent to a period of observation not exceeding three hours.
  • •Unable to make an informed decision about participation or demonstrating an inability to interpret information or follow study instructions
  • •Significant neurological or coordination impairment
  • •Unable to speak or understand English.
  • •Clostridium Difficile/ similar infection or unmanaged urinary incontinence.
  • •Evidence/ diagnosis of peripheral vascular disease.
  • •Lower limb amputation
  • •Polytrauma which prevents the adoption or normal lying, sitting or standing postures, or placement of the accelerometers

研究组 & 干预措施

Actigraph GT3X accelerometer

Other

Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg

干预措施: Accelerometer (Device)

结局指标

主要结局

Ability of an Accelerometer to Identify Step Count

时间窗: Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol

Agreement between direct observation and the activity monitors (ankle and thigh placements in isolation) in determination of step count. The mean difference (95% Limits of Agreement) between observed step count and accelerometer quantified step count for the same walk were calculated. Negative values reflected an underestimation of observed step count by the accelerometer and positive values reflected an overestimation of step count.

次要结局

  • Comfort of Accelerometers(Accelerometers were worn for a period not exceeding 3 hours)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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