NCT06633146

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
20mo left

Started Jun 2024

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jun 2024Dec 2027

Study Start

First participant enrolled

June 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 28, 2025

Status Verified

October 1, 2024

Enrollment Period

2.6 years

First QC Date

July 3, 2024

Last Update Submit

February 25, 2025

Conditions

StrokeStress, PsychologicalPost Traumatic Stress DisorderDepression, AnxietyLoneliness

Keywords

strokerehabilitationsocial supportcognitive functionsactivity

Outcome Measures

Primary Outcomes (1)

  • The effect of nature interventions on PROMIS questionnaire

    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 Outcomes (2)

  • The effect of nature interventions on moods assessed by GAD7

    4 weeks

  • The effect of nature-based intervention on neurocognitive functions in COMET questionnaire

    4 wk

Other Outcomes (3)

  • The effect of nature interventions on functional ability assessed by a validated questionnaire WHODAS

    4 weeks

  • The effect of nature interventions on microbiome

    4 weeks

  • The effect of nature interventions on the activity of autonomic nervous system

    4 weeks

Study Arms (2)

Nature intervention group

EXPERIMENTAL

Participants take part in therapeutic individual and group sessions organised in nearby nature by the research worker.

Behavioral: Therapies in nature

Control group

NO INTERVENTION

Participants do not participate in organised sessions but are encouraged to maintain physical activity and social life.

Interventions

Therapies in natureBEHAVIORAL

Therapeutic tasks in nature specifically designed for the study

Nature intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute stroke

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint Authority for Päijät-Häme Social and Health Care

Lahti, 15850, Finland

RECRUITING

Related Publications (1)

  • Salonen K, Hyvonen K, Paakkolanvaara JV, Korpela K. Flow With Nature Treatment for Depression: Participants' Experiences. Front Psychol. 2022 Jan 5;12:768372. doi: 10.3389/fpsyg.2021.768372. eCollection 2021.

    PMID: 35069344BACKGROUND

MeSH Terms

Conditions

StrokeStress, PsychologicalStress Disorders, Post-TraumaticDepressionAnxiety DisordersMotor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Hanna Haveri, MD PhD

    Wellbeing Services County of Paijat-Hame

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Haveri, MD PhD

CONTACT

+358 3 81911hanna.haveri@paijatha.fi

Marja Mikkelsson, Prof

CONTACT

+358 3 81911marja.mikkelsson@paijatha.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomised controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2024

First Posted

October 9, 2024

Study Start

June 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

February 28, 2025

Record last verified: 2024-10

Locations

FI(1)