Nature-based Therapies in Stroke Rehabilitation

Sponsor

Joint Authority for Päijät-Häme Social and Health Care (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05898542

Collaborator

Helsinki University Central Hospital (Other), University of Jyvaskyla (Other), Tampere University (Other), University of Eastern Finland (Other), Natural Resources Institute Finland (Other), University of Helsinki (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Stroke rehabilitation patients are subjected to additional nature-based therapies during a rehabilitation ward period.

Condition or Disease	Intervention/Treatment	Phase
Rehabilitation Stroke	Procedure: Nature-based therapy	N/A

Detailed Description

Inward stroke rehabilitation patients are selected randomly into two groups: intervention and control groups in proportions 1-2:1. Blood samples and microbiom 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 trice 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 adviced to do simple, more conventional rehabilitative tasks indoors.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised controlled study, intervention and control groupsRandomised controlled study, intervention and control groups

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nature-based therapy intervention group Patients getting additional therapies outdoors	Procedure: Nature-based therapy Therapy sessions conducted outdoors
No Intervention: Control group Patients getting additional rehabitation tasks indoors

Arm

Intervention/Treatment

Experimental: Nature-based therapy intervention group

Patients getting additional therapies outdoors

Procedure: Nature-based therapy

Therapy sessions conducted outdoors

No Intervention: Control group

Patients getting additional rehabitation tasks indoors

Outcome Measures

Primary Outcome Measures

PROMIS [0-30 days]
Functional deficits

Secondary Outcome Measures

WHODAS [0-30 days]
Eg life quality
GAS [0-120 days]
Mental status
Therapeutic effects [0-30 days]
Core-10
Microbiom [0-120 days]
Microbial analyses of stool, saliva and flakes of skin
Nerve system activity [0-30 days]
A portable device measurement eg heart rate and activity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Study Director: Hanna Haveri, MD PhD, Päijät-Hämeen Hyvinvointialue

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joint Authority for Päijät-Häme Social and Health Care

ClinicalTrials.gov Identifier:

NCT05898542

Other Study ID Numbers:

Q062

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Joint Authority for Päijät-Häme Social and Health Care

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jun 12, 2023