Nature-based Therapies in Stroke Rehabilitation
Primary Purpose
Rehabilitation, Stroke
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nature-based therapy
Sponsored by
About this trial
This is an interventional treatment trial for Rehabilitation focused on measuring rehabilitation, stroke, nature-based, therapy, microbiom, gut-brain axis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nature-based therapy intervention group
Control group
Arm Description
Patients getting additional therapies outdoors
Patients getting additional rehabitation tasks indoors
Outcomes
Primary Outcome Measures
PROMIS
Functional deficits
Secondary Outcome Measures
WHODAS
Eg life quality
GAS
Mental status
Therapeutic effects
Core-10
Microbiom
Microbial analyses of stool, saliva and flakes of skin
Nerve system activity
A portable device measurement eg heart rate and activity
Full Information
NCT ID
NCT05898542
First Posted
June 2, 2023
Last Updated
June 2, 2023
Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Helsinki University Central Hospital, University of Jyvaskyla, Tampere University, University of Eastern Finland, Natural Resources Institute Finland, University of Helsinki
1. Study Identification
Unique Protocol Identification Number
NCT05898542
Brief Title
Nature-based Therapies in Stroke Rehabilitation
Official Title
Nature-based Therapies Supporting Conventional Therapies in Promoting Stroke Rehabilitation: a Randomised Controlled Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 31, 2023 (Anticipated)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Helsinki University Central Hospital, University of Jyvaskyla, Tampere University, University of Eastern Finland, Natural Resources Institute Finland, University of Helsinki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stroke rehabilitation patients are subjected to additional nature-based therapies during a rehabilitation ward period.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation, Stroke
Keywords
rehabilitation, stroke, nature-based, therapy, microbiom, gut-brain axis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled study, intervention and control groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nature-based therapy intervention group
Arm Type
Experimental
Arm Description
Patients getting additional therapies outdoors
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients getting additional rehabitation tasks indoors
Intervention Type
Procedure
Intervention Name(s)
Nature-based therapy
Intervention Description
Therapy sessions conducted outdoors
Primary Outcome Measure Information:
Title
PROMIS
Description
Functional deficits
Time Frame
0-30 days
Secondary Outcome Measure Information:
Title
WHODAS
Description
Eg life quality
Time Frame
0-30 days
Title
GAS
Description
Mental status
Time Frame
0-120 days
Title
Therapeutic effects
Description
Core-10
Time Frame
0-30 days
Title
Microbiom
Description
Microbial analyses of stool, saliva and flakes of skin
Time Frame
0-120 days
Title
Nerve system activity
Description
A portable device measurement eg heart rate and activity
Time Frame
0-30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Haveri, MD PhD
Phone
+358444828225
Email
hanna.haveri@paijatha.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Marja Mikkelsson, Prof
Email
marja.mikkelsson@paijatha.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Haveri, MD PhD
Organizational Affiliation
Päijät-Hämeen Hyvinvointialue
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nature-based Therapies in Stroke Rehabilitation
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