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NCT Number: NCT06633146

Stroke Rehabilitation Utilizing Therapeutical Methods Designed for Nature Environments

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.

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Key information

Conditions

Stroke Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Depression, Anxiety Loneliness Mental Disorders Motor Activity Nervous System Diseases Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Stress, Psychological Trauma and Stressor Related Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint Authority for Päijät-Häme Social and Health Care

Lahti, 15850, Finland

Location status: Recruiting

Location contact

Hanna Haveri, MD PhD

CONTACT

[email protected]

+358 3 81911

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute stroke

Exclusion criteria

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

Treatment and study plan

Therapies in nature

Behavioral

Therapeutic tasks in nature specifically designed for the study

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. The effect of nature interventions on microbiome

    Time frame: 4 weeks

    Microbiological analyses from skin flake and stool samples

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna Haveri, MD PhD

CONTACT

[email protected]

+358 3 81911

Marja Mikkelsson, Prof

CONTACT

[email protected]

+358 3 81911

Sponsors and collaborators

Lead sponsor

Joint Authority for Päijät-Häme Social and Health Care

Other

Collaborators

  • Tampere University
  • University of Helsinki
  • University of Jyvaskyla

Registry information

Official study title

Outpatient Stroke Rehabilitation Supported by Nature Interventions

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 9, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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