RehabilitationNCT05898542
Nature-based Therapies in Stroke Rehabilitation
A study testing Nature-based therapy in people with Rehabilitation and Stroke, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
Trial summary
Stroke rehabilitation patients are subjected to additional nature-based therapies during a rehabilitation ward period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation, Stroke
- What is being tested?
- Nature-based therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 31 May 2023to 31 Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acute/Subacute stroke
- Rehabilitation ward patient
Who cannot join
- Incapable of independent decision making
- Traumatic bleeding in brain tissue
- Severe aphasia
- Severe, malign ongoing disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marja Mikkelsson, Prof contact
Finland1 site, 1 recruiting
- Recruiting
Joint Authority for Päijät-Häme Social and Health Care
Lahti, 15850
About this study
Official title: Nature-based Therapies Supporting Conventional Therapies in Promoting Stroke Rehabilitation: a Randomised Controlled Pilot Study.
Stroke rehabilitation patients are subjected to additional nature-based therapies during a rehabilitation ward period.
Read the detailed description
Inward stroke rehabilitation patients are selected randomly into two groups: intervention and control groups in proportions 1-2:1. Blood samples and microbiome 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 thrice 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 advised to do simple, more conventional rehabilitative tasks indoors.
- Conditions
- Rehabilitation, Stroke
- Being tested
- Nature-based therapy
- Keywords
- rehabilitation, stroke, nature-based, therapy, microbiome, gut-brain axis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-based therapyProcedure or surgery
Therapy sessions conducted outdoors
| Study group | Role | What they receive |
|---|---|---|
| Nature-based therapy intervention group | Experimental | Patients getting additional therapies outdoors Receives: Procedure: Nature-based therapy |
| Control group | No intervention | Patients getting additional rehabilitation tasks indoors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional ability
Evaluation of functional ability in intervention and control groups by Patient-Reported Outcomes Measurement Information (PROMIS) questionnaire
Measured: 0-30 days
Secondary outcomes (5)
Quality of life by WHO Disability Assessment Schedule (WHODAS)
Evaluation of quality of life in intervention and control groups, measured by WHODAS questionnaire.
Measured: 0-30 days
Assessment of the intervention impacts on rehabilitation
Evaluation of the impact of intervention into achieving the predetermined goals of rehabilitation. Measured by Goal Attainment Scale (GAS) in intervention and control group.
Measured: 0-120 days
Psychological or psychotherapeutic effects
Evaluation of the effect of interventions to psychological well-being or psychotherapeutic effect in comparison to control groups. Measurement by Core-10-survey.
Measured: 0-30 days
Intervention effects on microbiome
Measurement of the effect of intervention on participant microbiome compared to participant microbiome in the control group. Microbial analyses of stool, saliva and flakes of skin.
Measured: 0-120 days
Intervention effect on the activity of autonomic nerve system
The activity of autonomic nerve system is measured with a portable device recording eg heart rate and activity. The activity of autonomic nerve system is measured both in intervention and control group.
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start31 May 2023
- Primary completion28 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled study, intervention and control groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, University of Jyvaskyla, Tampere University, University of Eastern Finland, Natural Resources Institute Finland, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Hanna Haveri, MD PhD, Study director, Päijät-Hämeen Hyvinvointialue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898542
- Sponsor's protocol ID
- Q062
- Status last verified
- Jul 2024
- First submitted
- 2 Jun 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nature-based Therapies Supporting Conventional Therapies in Promoting Stroke Rehabilitation: a Randomised Controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT05898542
- Acronym / sponsor ID
- Q062
- Conditions
- Rehabilitation, Stroke
- Keywords
- rehabilitation, stroke, nature-based, therapy, microbiome, gut-brain axis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, University of Jyvaskyla, Tampere University, University of Eastern Finland, Natural Resources Institute Finland, University of Helsinki
- Study start
- 31 May 2023 (actual)
- Primary completion
- 28 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 2023 (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.
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 microbiome 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 thrice 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 advised to do simple, more conventional rehabilitative tasks indoors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled study, intervention and control groups
| Arm | Type | Receives |
|---|---|---|
| Nature-based therapy intervention group | Experimental | Procedure: Nature-based therapyPatients getting additional therapies outdoors |
| Control group | No intervention | –Patients getting additional rehabilitation tasks indoors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute/Subacute stroke
- Rehabilitation ward patient
Key exclusion criteria (4 listed)
- Incapable of independent decision making
- Traumatic bleeding in brain tissue
- Severe aphasia
- Severe, malign ongoing disease
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 |
|---|---|---|
| Nature-based therapyTherapy sessions conducted outdoors | Procedure or surgery | Nature-based therapy intervention group |
Primary outcome
Functional ability
Time frame: 0-30 days
Evaluation of functional ability in intervention and control groups by Patient-Reported Outcomes Measurement Information (PROMIS) questionnaire
5 secondary outcomes
Quality of life by WHO Disability Assessment Schedule (WHODAS)
Time frame: 0-30 days
Assessment of the intervention impacts on rehabilitation
Time frame: 0-120 days
Psychological or psychotherapeutic effects
Time frame: 0-30 days
Intervention effects on microbiome
Time frame: 0-120 days
Intervention effect on the activity of autonomic nerve system
Time frame: 0-30 days
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 3 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Marja Mikkelsson, Prof contact
Hanna Haveri, MD PhD study director
Päijät-Hämeen Hyvinvointialue
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature-based therapy in people with Rehabilitation and Stroke, 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 2 inclusion and 4 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 3 Jul 2024. 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 (+358444828225, hanna.haveri@paijatha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional ability (time frame: 0-30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.