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Nature-based Therapies in Stroke Rehabilitation

Nature-based Therapies Supporting Conventional Therapies in Promoting Stroke Rehabilitation: a Randomised Controlled Pilot Study.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05898542
Enrollment
60
Registered
2023-06-12
Start date
2023-05-31
Completion date
2026-12-31
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation, Stroke

Keywords

rehabilitation, stroke, nature-based, therapy, microbiome, gut-brain axis

Brief summary

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.

Interventions

Therapy sessions conducted outdoors

Sponsors

Helsinki University Central Hospital
CollaboratorOTHER
University of Jyvaskyla
CollaboratorOTHER
Tampere University
CollaboratorOTHER
University of Eastern Finland
CollaboratorOTHER
Natural Resources Institute Finland
CollaboratorOTHER_GOV
University of Helsinki
CollaboratorOTHER
Joint Authority for Päijät-Häme Social and Health Care
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomised controlled study, intervention and control groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Acute/Subacute stroke * Rehabilitation ward patient

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Functional ability0-30 daysEvaluation of functional ability in intervention and control groups by Patient-Reported Outcomes Measurement Information (PROMIS) questionnaire

Secondary

MeasureTime frameDescription
Quality of life by WHO Disability Assessment Schedule (WHODAS)0-30 daysEvaluation of quality of life in intervention and control groups, measured by WHODAS questionnaire.
Assessment of the intervention impacts on rehabilitation0-120 daysEvaluation of the impact of intervention into achieving the predetermined goals of rehabilitation. Measured by Goal Attainment Scale (GAS) in intervention and control group.
Psychological or psychotherapeutic effects0-30 daysEvaluation of the effect of interventions to psychological well-being or psychotherapeutic effect in comparison to control groups. Measurement by Core-10-survey.
Intervention effects on microbiome0-120 daysMeasurement 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.
Intervention effect on the activity of autonomic nerve system0-30 daysThe 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.

Countries

Finland

Contacts

Primary ContactHanna Haveri, MD PhD
hanna.haveri@paijatha.fi+358444828225
Backup ContactMarja Mikkelsson, Prof
marja.mikkelsson@paijatha.fi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026