Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05898542

Nature-based Therapies in Stroke Rehabilitation

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint Authority for Päijät-Häme Social and Health Care

Lahti, 15850, Finland

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nature-based therapy

Procedure

Therapy sessions conducted outdoors

Primary outcomes

  1. Functional ability

    Time frame: 0-30 days

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

Secondary outcomes

  1. Quality of life by WHO Disability Assessment Schedule (WHODAS)

    Time frame: 0-30 days

    Evaluation of quality of life in intervention and control groups, measured by WHODAS questionnaire.

  2. Assessment of the intervention impacts on rehabilitation

    Time frame: 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.

  3. Psychological or psychotherapeutic effects

    Time frame: 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.

  4. Intervention effects on microbiome

    Time frame: 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.

  5. Intervention effect on the activity of autonomic nerve system

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna Haveri, MD PhD

CONTACT

[email protected]

+358444828225

Marja Mikkelsson, Prof

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Joint Authority for Päijät-Häme Social and Health Care

Other

Collaborators

  • Helsinki University Central Hospital
  • Natural Resources Institute Finland
  • Tampere University
  • University of Eastern Finland
  • University of Helsinki
  • University of Jyvaskyla

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.