Haukeland University Hospital
Bergen, N-5021, Norway
NCT Number: NCT00771771
The main purpose of this study is to evaluate the benefit of early supported discharge (ESD) in rehabilitation of stroke patients in two different outpatient modalities.
In a collaborating study, changes in physical function as well as the patients' own perception of physical function, pain and fatigue will be studied. In further collaborating studies, health economics and organizational issues will also be evaluated.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Bergen, N-5021, Norway
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:
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day unit
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in the patient's home
Time frame: 6 months
Modified Rankin Scale
Time frame: 3, 6 and 12 months
National Institutes of Health Stroke Scale
Time frame: 3, 6, 12 and 24 months
Barthel ADL Index
Time frame: 3 and 6 months
Assessment of Motor and Process Skills
Time frame: 3 and 6 months
Trunk Impairment Scale
Time frame: 12 months
Stroke Impact Scale
Time frame: 12 months
Relative Stress Scale
Time frame: 12 and 24 months
Patients' Global Impression of Change
Time frame: 12 and 24 months
Short Form (36) Health Survey
Time frame: 3, 12 and 24 months
Modified Rankin Scale
Time frame: 3 and 6 months
Time frame: 3 and 6 months
Time frame: 3 and 6 months
Time frame: 3 and 6 months
Time frame: 3 and 12 months
Haukeland University Hospital
Other
Early Supported Discharge After Stroke in Bergen. An RCT Looking at the Collaboration Between Hospital Service and Primary Health Care.
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.
NCT02425345
Arterial Occlusive Diseases, Arteriosclerosis
View Trial DetailsNCT05589402
Bone Diseases, Brain Diseases
Harlingen, Texas, United States
View Trial DetailsNCT06750692
Brain Diseases, Cardiovascular Diseases
Afyonkarahisar, Turkey (Türkiye)
View Trial DetailsNCT04992195
Alzheimer Disease, Arterial Thromboembolism
Hong Kong
View Trial Details