NCT02435043

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

2.7 years

First QC Date

April 7, 2015

Last Update Submit

February 12, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Post stroke fatigue

    Mental Fatigue Scale (MFS) pre-post design by blinded assessor.

    8 months after inclusion

  • Occupational value of everyday occupation

    Occupational Value (OVal-pd) pre-post design by blinded assessor

    8 months after inclusion

Study Arms (2)

Nature based rehabilitation

EXPERIMENTAL

ten weeks of nature-based rehabilitation, as add-on to standard management

Other: Nature based rehabilitation

Treatment as usual

ACTIVE COMPARATOR

standard management after stroke

Other: standard management after stroke

Interventions

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.

Nature based rehabilitation

standard management after stroke is individualised.

Treatment as usual

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Dementia
  • Severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne university hospital

Malmo, 205 02, Sweden

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hélène Pessah-Rasmussen, MD, Ph.D.

    Skane University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

May 6, 2015

Study Start

August 1, 2012

Primary Completion

May 1, 2015

Study Completion

January 1, 2020

Last Updated

February 13, 2020

Record last verified: 2020-02

Locations