Nature-based Therapies Supporting Conventional Therapies in Promoting Stroke Rehabilitation: a Randomised Controlled Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Functional ability
研究概览
简要总结
Stroke rehabilitation patients are subjected to additional nature-based therapies during a rehabilitation ward period.
详细描述
Inward stroke rehabilitation patients are selected randomly into two groups: intervention and control groups in proportions 1-2:1. Blood samples and microbiome samples of saliva, skin and feces are taken from all patients prior to interventions. These are controlled after 4 weeks from the beginning of the study and 3 months after signing-off the ward. Questionnaires eg on moods, life quality and function deficits are conducted in the beginning of the study, after 4 weeks from the start and 3 months after signing-off. Physiological measurements will be done to observe autonomic nerve status. The interventions consisting of therapy sessions in the hospital nearby nature will be conducted thrice a week one of them being an individual nature-visit with the research worker, one in group and one with family-member or volunteer. The moods and quality of life of the family-member participating in the study will also be followed up. The control group is advised to do simple, more conventional rehabilitative tasks indoors.
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
- 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
- 是
入选标准
- •Acute/Subacute stroke
- •Rehabilitation ward patient
排除标准
- •Incapable of independent decision making
- •Traumatic bleeding in brain tissue
- •Severe aphasia
- •Severe, malign ongoing disease
结局指标
主要结局
Functional ability
时间窗: 0-30 days
Evaluation of functional ability in intervention and control groups by Patient-Reported Outcomes Measurement Information (PROMIS) questionnaire
次要结局
- Quality of life by WHO Disability Assessment Schedule (WHODAS)(0-30 days)
- Intervention effects on microbiome(0-120 days)
- Assessment of the intervention impacts on rehabilitation(0-120 days)
- Intervention effect on the activity of autonomic nerve system(0-30 days)
- Psychological or psychotherapeutic effects(0-30 days)
