Nature-based Therapies in Stroke Rehabilitation

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Rehabilitation
• Intervention / Treatment: Procedure: Nature-based therapy

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanna Haveri, MD PhD; Phone Number: +358444828225; Email: hanna.haveri@paijatha.fi
• Study Contact Backup: Name: Marja Mikkelsson, Prof; Email: marja.mikkelsson@paijatha.fi

Study Locations

• Finland
  • Lahti, Finland, 15850
    • Recruiting
    • Joint Authority for Päijät-Häme Social and Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 rehabilitation tasks indoors

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life by WHO Disability Assessment Schedule (WHODAS)	Evaluation of quality of life in intervention and control groups, measured by WHODAS questionnaire.	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.	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.	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.	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.	0-30 days

Collaborators and Investigators

• Sponsor: Joint Authority for Päijät-Häme Social and Health Care
• Collaborators: Helsinki University Central Hospital; University of Helsinki; Tampere University; University of Eastern Finland; University of Jyvaskyla; Natural Resources Institute Finland
• Investigators: Study Director: Hanna Haveri, MD PhD, Päijät-Hämeen Hyvinvointialue

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): March 28, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; microbiome; therapy; gut-brain axis; nature-based
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Q062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No