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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05898542
Other study ID # Q062
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 31, 2023
Est. completion date February 28, 2024

Study information

Verified date June 2023
Source Joint Authority for Päijät-Häme Social and Health Care
Contact Hanna Haveri, MD PhD
Phone +358444828225
Email hanna.haveri@paijatha.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stroke rehabilitation patients are subjected to additional nature-based therapies during a rehabilitation ward period.


Description:

Inward stroke rehabilitation patients are selected randomly into two groups: intervention and control groups in proportions 1-2:1. Blood samples and microbiom 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 trice 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 adviced to do simple, more conventional rehabilitative tasks indoors.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Acute/Subacute stroke, rehabilitation ward patient Exclusion Criteria: Incapable of independent decision making Traumatic bleeding in brain tissue Severe aphasia Severe, malign ongoing disease

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Nature-based therapy
Therapy sessions conducted outdoors

Locations

Country Name City State
n/a

Sponsors (7)

Lead Sponsor Collaborator
Joint Authority for Päijät-Häme Social and Health Care Helsinki University Central Hospital, Natural Resources Institute Finland, Tampere University, University of Eastern Finland, University of Helsinki, University of Jyvaskyla

Outcome

Type Measure Description Time frame Safety issue
Primary PROMIS Functional deficits 0-30 days
Secondary WHODAS Eg life quality 0-30 days
Secondary GAS Mental status 0-120 days
Secondary Therapeutic effects Core-10 0-30 days
Secondary Microbiom Microbial analyses of stool, saliva and flakes of skin 0-120 days
Secondary Nerve system activity A portable device measurement eg heart rate and activity 0-30 days
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