Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- modified Rankin Scale
研究概览
简要总结
Objective: To evaluate the effect of interdisciplinary home rehabilitation of patients with acute stroke. The trial seeks to evaluate:
- Can early home rehabilitation affect the degree of independence (motor capacity, activities of daily living and cognitive status), quality of life and the possibility of discharge to own home?
- Can home rehabilitation influence the length of admission at a rehabilitation centre in the municipality, readmission to hospital, the use of healthcare services and death?
- To what extend can home rehabilitation be implemented according to finances? Materials and methods: Patients at the age 18 years or more admitted to the stroke unit at the University Hospital of Gentofte. The patients were eligible when meeting the following criteria: symptoms of stroke, need of rehabilitation tree days after admission, living in own home in the Municipality of Gentofte, Lyngby-Taarbaek or Rudersdal and Modified Rankin Score between 0 and 3.
The trial was conducted as a randomised controlled trial. The control group patients were rehabilitated according to normal procedure. The intervention group patients were rehabilitated according to normal procedure and were additionally rehabilitated at home during admission and four weeks after discharge.
详细描述
Objectives were to assess the efficacy of home-based stroke rehabilitation compared to standard care in stroke patients using an interventional, randomised, safety/efficacy open-label trial and parallel assignment. The setting was single-center, stroke unit at the University Hospital of Copenhagen, Gentofte, although patients were recruited through a collaboration of several municipalities.
Participants were eligible patients with a clinical diagnosis of stroke and focal neurological deficits hospitalised in a stroke unit for more than three days and in need of rehabilitation.
Interventions patients were randomised to home-based rehabilitation during hospitalization and for up to 4 weeks after discharge to replace part of usual treatment and rehabilitation services. Control patients received treatment and rehabilitation following usual guidelines for the treatment of stroke patients.
Main outcome measures 90 days post-stroke, modified Rankin Scale, and motor rehabilitation, cognitive abilities, quality of life and treatment-associated economy as secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •18 years or more,
- •Symptoms of stroke,
- •Need of rehabilitation tree days after admission,
- •Living in own home,
- •Modified Rankin Score between 0 and 3
排除标准
- •Terminal care,
- •Discharged from another department, Living in nursery home,
- •Can not understand the Danish language,
- •Memory difficulties
结局指标
主要结局
modified Rankin Scale
时间窗: 90 days
To investigate differences in the modified Rankin Scale among intervention and control patients at the inclusion time point and 90 days later.
次要结局
- Motor Assessment Scale(90)
- CT-50 Cognitive Test(90)
- EuroQol-5D™ quality of life measurement(90)
- Barthel-100 Index(90)
研究者
Rune Skovgaard Rasmussen, PhD
MA, PhD
University Hospital, Gentofte, Copenhagen