StrokeNCT06633146
Stroke Rehabilitation Utilizing Therapeutical Methods Designed for Nature Environments
A study testing Therapies in nature in people with Stroke and Stress, Psychological, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stress, Psychological, Post Traumatic Stress Disorder
- What is being tested?
- Therapies in nature
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute stroke
Who cannot join
- Traumatic intracranial bleeding without stroke
- A malign, aggressive disease
- Severe aphasia or incapable of independent decision making
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Joint Authority for Päijät-Häme Social and Health Care
Lahti, 15850
Hanna Haveri, MD PhD, +358 3 81911, hanna.haveri@paijatha.fi
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Stress, Psychological, Post Traumatic Stress Disorder, Depression, Anxiety, Loneliness
- Being tested
- Therapies in nature
- Keywords
- stroke, rehabilitation, social support, cognitive functions, activity
- Medical subject headings
- Stroke, Stress, Psychological, Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapies in natureBehavioural
Therapeutic tasks in nature specifically designed for the study
| Study group | Role | What they receive |
|---|---|---|
| Nature intervention group | Experimental | Participants take part in therapeutic individual and group sessions organised in nearby nature by the research worker. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
The effect of nature interventions on moods assessed by GAD7
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.
Measured: 4 weeks
The effect of nature-based intervention on neurocognitive functions in COMET questionnaire
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.
Measured: 4 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, University of Jyvaskyla, Tampere University
- Responsible party
- Sponsor
- Investigators
- Hanna Haveri, MD PhD, Principal investigator, Wellbeing Services County of Paijat-Hame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633146
- Sponsor's protocol ID
- HA/2233 Q062
- Status last verified
- Oct 2024
- First submitted
- 3 Jul 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35069344
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Stroke Rehabilitation Supported by Nature Interventions
- ClinicalTrials.gov ID
- NCT06633146
- Acronym / sponsor ID
- HA/2233 Q062
- Conditions
- Stroke, Stress, Psychological, Post Traumatic Stress Disorder, Depression, Anxiety, Loneliness
- Keywords
- stroke, rehabilitation, social support, cognitive functions, activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Collaborators
- University of Helsinki, University of Jyvaskyla, Tampere University
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomised controlled study
| Arm | Type | Receives |
|---|---|---|
| Nature intervention group | Experimental | Behavioral: Therapies in natureParticipants take part in therapeutic individual and group sessions organised in nearby nature by the research worker. |
| Control group | No intervention | –Participants do not participate in organised sessions but are encouraged to maintain physical activity and social life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute stroke
Key exclusion criteria (3 listed)
- Traumatic intracranial bleeding without stroke
- A malign, aggressive disease
- Severe aphasia or incapable of independent decision making
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapies in natureTherapeutic tasks in nature specifically designed for the study | Behavioural | Nature intervention group |
Primary outcome
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.
2 secondary outcomes
The effect of nature interventions on moods assessed by GAD7
Time frame: 4 weeks
The effect of nature-based intervention on neurocognitive functions in COMET questionnaire
Time frame: 4 wk
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 35069344Salonen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanna Haveri, MD PhD principal investigator
Wellbeing Services County of Paijat-Hame
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapies in nature in people with Stroke and Stress, Psychological, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Haveri, MD PhD (+358 3 81911, hanna.haveri@paijatha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of nature interventions on PROMIS questionnaire (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06633146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.