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临床试验/NCT05571462
NCT05571462进行中(未招募)不适用

Mobility and Activity Patterns in Hospitalised Patients With Severe Acquired Brain Injury Undergoing Rehabilitation. The MAP-study.

Christian Riberholt1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Early physical activity

研究概览

简要总结

The purpose of this observational study is to quantify physical activity patterns in patients with severe acquired brain injury admitted for in-hospital rehabilitation.

详细描述

Patients admitted for rehabilitation will be included for two periods of one-week monitorization of physical activity. The investigators will include all patients with moderate to severe brain injury.

This is an observational cross-sectional study including patients 18 years or above. Patients with conditions such as unstable fractures that restricts mobilisation are excluded. Physical activity is measured continuously during rehabilitation at two separate seven-day periods using a body-worn activity tracker. The first period will be initiated in the early phase of rehabilitation (3 days after admission) and the second at the late phase (10 days before discharge).

Baseline variables considered predictors, confounders or modifiers for physical activity will be collected along with registration of variables during the measurement periods and functional outcome variables at discharge.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 18 years old

排除标准

  • Planned discharge within two weeks
  • Fractures of lower extremities, pelvis or spine prohibiting weight-bearing
  • Amputation of lower extremities

结局指标

主要结局

Early physical activity

时间窗: Continuous measure of physical activity during day three to ten of rehabilitation

Activity data collected in the early phase will be the exposure variable. Amount of minutes patients are physically active.

次要结局

  • Late physical activity(Continuous measure of physical activity during day three to ten before discharge from rehabilitation)
  • Early Functional Ability (EFA) score(Admission)
  • Glasgow Coma Scale (GCS) (admission)(Admission)
  • Agitated Behaviour Scale (ABS)(Day three to ten of rehabilitation)
  • Functional Independence Measure (discharge)(Discharge from rehabilitation (3 months))
  • Comorbidities at admission(Admission)
  • Ranchos Los Amigos Score(Admission)
  • Length of stay at intensive care unit(Retrospectively recorded at admission to the rehabilitation department)

研究者

发起方
Christian Riberholt
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christian Riberholt

Principal investigator

Rigshospitalet, Denmark

研究点 (1)

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