跳至主要内容
临床试验/NCT05898542
NCT05898542招募中不适用

Nature-based Therapies Supporting Conventional Therapies in Promoting Stroke Rehabilitation: a Randomised Controlled Pilot Study.

Joint Authority for Päijät-Häme Social and Health Care2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月31日最近更新:
适应症

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

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)

研究者

发起方
Joint Authority for Päijät-Häme Social and Health Care
申办方类型
Other
责任方
Sponsor

研究点 (2)

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