Overview

This trial is active, not recruiting.

Condition stroke
Treatments nature based rehabilitation, standard management after stroke
Sponsor Region Skane
Collaborator Lund University
Start date August 2012
End date November 2015
Trial size 101 participants
Trial identifier NCT02435043, 2012/352

Summary

The aim of NASTRU was to examine whether ten weeks of nature-based rehabilitation, as add-on to standard management, could influence post-stroke fatigue (primary outcome), depression, work ability or functional outcome (secondary outcomes), compared to controls.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ten weeks of nature-based rehabilitation, as add-on to standard management
nature based rehabilitation
ten weeks of nature-based rehabilitation, as add-on to standard management. A rehabilitation program in groups up to 8 patients in an especially designed garden at the Swedish University of Agricultural Sciences, Alnarp. The intervention was grounded in environmental psychology and occupational therapy, supported by a multimodal rehabilitation team that utilized the garden/nature for sensory stimulation, body awareness, meaningful occupations and nature experiences.
(Active Comparator)
standard management after stroke
standard management after stroke
standard management after stroke is individualised.

Primary Outcomes

Measure
Post stroke fatigue
time frame: 8 months after inclusion
Occupational value of everyday occupation
time frame: 8 months after inclusion

Eligibility Criteria

Male or female participants from 55 years up to 80 years old.

Inclusion Criteria: - Ischemic or haemorrhagic stroke - First ever or recurrence, about 3 months (group 1) or more than one year prior to screening (group 2) - Age: 55-80 years Exclusion criteria: - Dementia - Severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)

Additional Information

Official title A Randomized Controlled Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
Principal investigator Hélène Pessah-Rasmussen, MD, Ph.D.
Description Patients randomized to the intervention undergo a rehabilitation program in groups up to 8 patients in an especially designed garden at the Swedish University of Agricultural Sciences, Alnarp. The intervention is grounded in environmental psychology and occupational therapy, supported by a multimodal rehabilitation team that utilizes the garden/nature for sensory stimulation, body awareness, meaningful occupations and nature experiences. The enrollment of 101 patients (51 intervention; 50 control) was completed on August 2014. Follow-up is on-going, with assessments by examiner blinded to treatment group, at end of intervention period, 8 months, and 14 months after randomization. A parallel study with qualitative in-depth interviews in a subset of patients, who were randomized to the intervention group, as well as the staff, is also ongoing.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Region Skane.