Stroke Rehabilitation Utilizing Therapeutical Methods Designed for Nature Environments

February 25, 2025 updated by: Joint Authority for Päijät-Häme Social and Health Care

Outpatient Stroke Rehabilitation Supported by Nature Interventions

Outpatient participants with a recent stroke diagnoses receive complimentary rehabilitation. The nature interventions include ergo- and physiotherapeutic and neurocognitive tasks with the support of an psychotherapeutic frame designed to be performed in a nature environment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with an acute stroke are recruited to the study when signing out from the acute hospital care services. The patients are selected randomly into two groups: intervention and control groups in proportions 1:1. During the four-week study period the partipants in the control group are encouraged to maintain light physical activity 1 to 3 times per week with or without company. The research worker contacts the participants every week. In the nature group the research worker organises individual nature visits in the nearby nature twice a week and encourages the participants to go outdoors with a close-one once a week. All interventional contacts in the nature group are performed in a ecopsychotherapeutical frame consisting of ergo- and physiotherapeutic and neurocognitive tasks.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Lahti, Finland, 15850
        • Recruiting
        • Joint Authority for Päijät-Häme Social and Health Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute stroke

Exclusion Criteria:

  • Traumatic intracranial bleeding without stroke
  • A malign, aggressive disease
  • Severe aphasia or incapable of independent decision making

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nature intervention group
Participants take part in therapeutic individual and group sessions organised in nearby nature by the research worker.
Behavioral: Therapies in nature
Therapeutic tasks in nature specifically designed for the study
No Intervention: Control group
Participants do not participate in organised sessions but are encouraged to maintain physical activity and social life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of nature interventions on PROMIS questionnaire
Time Frame: 4 weeks
Self-assessed quality of life assessed by a PROMIS (patient-reported outcomes measurement information system) questionnaire. Time points measured wk 0 and wk 4, efficacy evaluated on the basis of the difference between these time points. An increase in the obtained score is considered a positive effect.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of nature interventions on moods assessed by GAD7
Time Frame: 4 weeks
Evaluation of anxiety scales by a GAD7 (generalised anxiety disorder 7) interview, the score of the questionnaire (0-21 points) is evaluated wk 0 and wk 4. A decrease in the total score is considered as a positive effect on moods.
4 weeks
The effect of nature-based intervention on neurocognitive functions in COMET questionnaire
Time Frame: 4 wk
Assessment of the efficacy of nature-based neuropsychological tasks on neurocognitive functions by a cognitive test COMET (cognitive method) -questionnaire. The total score is evaluated wk0 and wk4. An increase in the total score is considered a positive effect.
4 wk

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of nature interventions on microbiome
Time Frame: 4 weeks
Microbiological analyses from skin flake and stool samples
4 weeks
The effect of nature interventions on the activity of autonomic nervous system
Time Frame: 4 weeks
The evaluation of the state of the autonomic nervous system by heart rate variability by a portable device.
4 weeks
The effect of nature interventions on functional ability assessed by a validated questionnaire WHODAS
Time Frame: 4 weeks
Self-assessed functional ability in everyday life with a validated questionnaire WHODAS (WHO disability assessment scale). The total scores are evaluated wk0 and wk4. An increase in the total score is considered a positive effect.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joint Authority for Päijät-Häme Social and Health Care

Collaborators

University of Helsinki
Tampere University
University of Jyvaskyla

Investigators

  • Principal Investigator: Hanna Haveri, MD PhD, Wellbeing Services County of Paijat-Hame

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA/2233 Q062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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