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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
Joint Authority for Päijät-Häme Social and Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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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