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RecruitingNCT05898542Updated Jul 3, 2024

Nature-based Therapies in Stroke Rehabilitation

An interventional study of Nature-based therapy in Rehabilitation and Stroke, sponsored by Joint Authority for Päijät-Häme Social and Health Care. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Joint Authority for Päijät-Häme Social and Health Care · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rehabilitation
  • Stroke

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Keywords

  • rehabilitation
  • stroke
  • nature-based
  • therapy
  • microbiome
  • gut-brain axis
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 60 is above the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Joint Authority for Päijät-Häme Social and Health Care is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Acute/Subacute stroke
  • Rehabilitation ward patient

Exclusion criteria

Exclusion Criteria:

  • Incapable of independent decision making
  • Traumatic bleeding in brain tissue
  • Severe aphasia
  • Severe, malign ongoing disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Nature-based therapy intervention group

    Patients getting additional therapies outdoors

    Procedure: Nature-based therapy

  • No intervention
    Control group

    Patients getting additional rehabilitation tasks indoors

Interventions

  • ProcedureNature-based therapy

    Therapy sessions conducted outdoors

06

What researchers measure

Primary outcomes

  1. Functional ability

    Evaluation of functional ability in intervention and control groups by Patient-Reported Outcomes Measurement Information (PROMIS) questionnaire

    Time frame: 0-30 days

Secondary outcomes

  1. Quality of life by WHO Disability Assessment Schedule (WHODAS)

    Evaluation of quality of life in intervention and control groups, measured by WHODAS questionnaire.

    Time frame: 0-30 days

  2. 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.

    Time frame: 0-120 days

  3. 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.

    Time frame: 0-30 days

  4. 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.

    Time frame: 0-120 days

  5. 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.

    Time frame: 0-30 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05898542
Lead sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Helsinki University Central Hospital, University of Jyvaskyla, Tampere University, University of Eastern Finland, Natural Resources Institute Finland, University of Helsinki
Responsible party
Sponsor
First posted
Jun 12, 2023
Start date
May 31, 2023
Primary completion
Mar 28, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 3, 2024

Study contacts

Hanna Haveri, MD PhD
Contact
hanna.haveri@paijatha.fi
+358444828225
Marja Mikkelsson, Prof
Contact
marja.mikkelsson@paijatha.fi
Hanna Haveri, MD PhD
study director · Päijät-Hämeen Hyvinvointialue

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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