Nature-based Therapies in Stroke Rehabilitation

Not Applicable

Recruiting

• Conditions: Stroke; Rehabilitation
• Interventions: Procedure: Nature-based therapy

• Registration Number: NCT05898542
• Lead Sponsor: Joint Authority for Päijät-Häme Social and Health Care

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.

Study Timeline

• Study Start: 2023-05-31
• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-02
• Study First Posted: 2023-06-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2026-03-28
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nature-based therapy intervention group	Nature-based therapy	Patients getting additional therapies outdoors

Primary Outcome Measures

Name	Time	Method
Functional ability	0-30 days	Evaluation of functional ability in intervention and control groups by Patient-Reported Outcomes Measurement Information (PROMIS) questionnaire

Secondary Outcome Measures

Name	Time	Method
Quality of life by WHO Disability Assessment Schedule (WHODAS)	0-30 days	Evaluation of quality of life in intervention and control groups, measured by WHODAS questionnaire.
Intervention effects on microbiome	0-120 days	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.
Assessment of the intervention impacts on rehabilitation	0-120 days	Evaluation of the impact of intervention into achieving the predetermined goals of rehabilitation. Measured by Goal Attainment Scale (GAS) in intervention and control group.
Intervention effect on the activity of autonomic nerve system	0-30 days	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.
Psychological or psychotherapeutic effects	0-30 days	Evaluation of the effect of interventions to psychological well-being or psychotherapeutic effect in comparison to control groups. Measurement by Core-10-survey.

Trial Locations

Locations (1)

Joint Authority for Päijät-Häme Social and Health Care; 🇫🇮 Lahti, Finland