Completed

Early Supported Discharge After Stroke in Bergen. An RCT Looking at the Collaboration Between Hospital Service and Primary Health Care.

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What is being tested

Early supported discharge with day unit rehabilitation

+ Early supported discharge with home rehabilitation

Other
Who is being recruted

Brain Diseases+4

+ Cardiovascular Diseases

+ Central Nervous System Diseases

+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2008
See protocol details

Summary

Principal SponsorHaukeland University Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2008

Actual date on which the first participant was enrolled.

Early supported discharge (ESD) seems to be at least as effective as hospital rehabilitation after stroke, and possibly better. In this study patients with recent stroke will be randomized to one of three different treatment arms: * ESD with treatment at a day institution until 4 hrs. per day for up to 5 weeks * ESD with treatment in the patients' home until 4 hrs. per day for up to 5 weeks * Rehabilitation treatment "as usual", with a longer hospital stay, but without any specific treatment or follow-up after discharge The patients in the two ESD arms will in addition be followed closely by a multidisciplinary coordinating team during the stay in hospital and the 5 week period of treatment after discharge, and they will be offered follow-ups at 3 and 6 months after inclusion into the study. Patients in all 3 arms will be systematically examined with a set of measuring instruments as well as objective physical and function tests. This will be performed at inclusion and at 3, 6, 12 and 24 months after inclusion. In the collaborating study by physiotherapist Bente Gjelsvik a comparison between changes in trunk control, balance, walking and ADL 3 months post stroke, as well as the patients' perceptions of physical function, pain and fatigue, will be the main focus. To assess function, functional change and possible differences between different interventions, there is a need for reliable and valid outcome measures. As a basis for the use of the outcome measure Trunk Impairment Scale (TIS) in this study, the TIS has been translated into Norwegian, Trunk Impairment Scale - Norwegian version (TIS-NV) and will be examined for measurement properties using data from the above study as well as data from patients with brain damage recruited from the Department of Physical Rehabilitation Medicine, Haukeland University Hospital. An examination of a possible connection between localisation and size of the stroke and trunk control will also be performed, as characteristics of the stroke may have therapeutic implications for the choice of intervention for the individual patient. The research questions for the planned doctoral thesis for Bente Gjelsvik are therefore as follows: 1. Is the TIS-NV reliable and valid in patients with brain damage? 2. Are changes in trunk control, balance, walking and daily activities, as well as pain and fatigue 3 months post stroke different in patients who have received interventions from different courses of rehabilitation in the study "Early supported discharge after stroke in Bergen"? To which degree do the patients perceive problems related to balance, physical activity, walking, pain and fatigue? 3. Is there a correlation between localization and size of the stroke as measured by magnetic tomography, and the patients' trunk control? Are initial localization and size of the stroke predictive for the patients' trunk control 3 months post stroke? Another collaborating project is carried out by PhD candidate Hedda Døli (Language outcome after stroke: lesion location, prognosis and consequences). The aim of her first study in the PhD project is to investigate the relationship between lesion location and aphasia severity one week post-stroke. Thereafter a follow-up study of the same patients 12 months post-stroke investigates the prognosis of aphasia and the variables that may influence recovery. In the third study the aim is to investigate the health-related quality of life and the occurrence of depression in patients with aphasia.

Official TitleEarly Supported Discharge After Stroke in Bergen. An RCT Looking at the Collaboration Between Hospital Service and Primary Health Care.
Principal SponsorHaukeland University Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

306 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

Criteria

5 inclusion criteria required to participate
Living in own home in the community of Bergen, Norway

Inclusion within 1-7 days (24-168 hours) after debut of symptoms

Inclusion within 6-120 hours after admission to Department of Neurology

NIHSS score 2-26 at inclusion OR NIHSS score < 2 if Modified Rankin Scale is 2 or higher when being 0 before the stroke

Show More Criteria

4 exclusion criteria prevent from participating
Serious psychic illness

Serious drug abuse

Serious medical conditions that can influence the patients' cerebrovascular disease or rehabilitation

Poor knowledge of the Norwegian language

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Discharge from the hospital to the patients' homes as soon as possible, supported by an out-patient ambulatory coordinating multidisciplinary team. The patients will be offered rehabilitation in a day unit, and multidisciplinary policlinical follow-ups will be performed 3 and 6 months after inclusion.

Group II

Active Comparator
Discharge from the hospital to the patients' homes as soon as possible, supported by an out-patient ambulatory coordinating multidisciplinary team. The patients will be offered rehabilitation treatment in their homes, and multidisciplinary policlinical follow-ups will be performed 3 and 6 months after inclusion.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Haukeland University Hospital

Bergen, NorwayOpen Haukeland University Hospital in Google Maps
CompletedOne Study Center