NCT05898542

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
May 2023Dec 2026

Study Start

First participant enrolled

May 31, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2.8 years

First QC Date

June 2, 2023

Last Update Submit

July 1, 2024

Conditions

RehabilitationStroke

Keywords

rehabilitationstrokenature-basedtherapymicrobiomegut-brain axis

Outcome Measures

Primary Outcomes (1)

  • Functional ability

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

    0-30 days

Secondary Outcomes (5)

  • Quality of life by WHO Disability Assessment Schedule (WHODAS)

    0-30 days

  • Assessment of the intervention impacts on rehabilitation

    0-120 days

  • Psychological or psychotherapeutic effects

    0-30 days

  • Intervention effects on microbiome

    0-120 days

  • Intervention effect on the activity of autonomic nerve system

    0-30 days

Study Arms (2)

Nature-based therapy intervention group

EXPERIMENTAL

Patients getting additional therapies outdoors

Procedure: Nature-based therapy

Control group

NO INTERVENTION

Patients getting additional rehabilitation tasks indoors

Interventions

Nature-based therapyPROCEDURE

Therapy sessions conducted outdoors

Nature-based therapy intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute/Subacute stroke
  • Rehabilitation ward patient

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint Authority for Päijät-Häme Social and Health Care

Lahti, 15850, Finland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hanna Haveri, MD PhD

    Päijät-Hämeen Hyvinvointialue

    STUDY DIRECTOR

Central Study Contacts

Hanna Haveri, MD PhD

CONTACT

+358444828225hanna.haveri@paijatha.fi

Marja Mikkelsson, Prof

CONTACT

marja.mikkelsson@paijatha.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled study, intervention and control groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 12, 2023

Study Start

May 31, 2023

Primary Completion

March 28, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)