A Randomized Controlled Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Occupational value of everyday occupation
研究概览
简要总结
The aim of NASTRU was to examine whether ten weeks of nature-based rehabilitation, as add-on to standard management, could influence post-stroke fatigue (primary outcome), depression, work ability or functional outcome (secondary outcomes), compared to controls.
详细描述
Patients randomized to the intervention undergo a rehabilitation program in groups up to 8 patients in an especially designed garden at the Swedish University of Agricultural Sciences, Alnarp. The intervention is grounded in environmental psychology and occupational therapy, supported by a multimodal rehabilitation team that utilizes the garden/nature for sensory stimulation, body awareness, meaningful occupations and nature experiences.
The enrollment of 101 patients (51 intervention; 50 control) was completed on August 2014. Follow-up is on-going, with assessments by examiner blinded to treatment group, at end of intervention period, 8 months, and 14 months after randomization. A parallel study with qualitative in-depth interviews in a subset of patients, who were randomized to the intervention group, as well as the staff, is also ongoing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or haemorrhagic stroke
- •First ever or recurrence, about 3 months (group 1) or more than one year prior to screening (group 2)
- •Age: 55-80 years
- •Exclusion criteria:
- •Severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)
排除标准
- 未提供
结局指标
主要结局
Occupational value of everyday occupation
时间窗: 8 months after inclusion
Occupational Value (OVal-pd) pre-post design by blinded assessor
Post stroke fatigue
时间窗: 8 months after inclusion
Mental Fatigue Scale (MFS) pre-post design by blinded assessor.
次要结局
未报告次要终点