|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Haukeland University Hospital |
|---|---|
| Collaborators: |
University of Bergen Municipality of Bergen, Norway Kavli Research Centre for Ageing and Dementia Innovest AS |
| Information provided by (Responsible Party): | Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT00771771 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke |
Other: Early supported discharge with day unit rehabilitation Other: Early supported discharge with home rehabilitation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Early Supported Discharge After Stroke in Bergen. An RCT Looking at the Collaboration Between Hospital Service and Primary Health Care. |
| Enrollment: | 347 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Day unit rehabilitation
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.
|
Other: Early supported discharge with day unit rehabilitation
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day unit
|
|
Active Comparator: Home rehabilitation
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.
|
Other: Early supported discharge with home rehabilitation
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in the patient's home
|
|
No Intervention: Treatment as usual
Patients will receive rehabilitation treatment after today's principles and routines.
|
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:
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Norway | |
| Haukeland University Hospital | |
| Bergen, Norway, N-5021 | |
| Study Director: | Jan S. Skouen, PhD | Haukeland University Hospital |
More Information
| Responsible Party: | Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT00771771 History of Changes |
| Other Study ID Numbers: | 18993 |
| Study First Received: | October 10, 2008 |
| Last Updated: | January 3, 2012 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
|
Stroke Rehabilitation Early Supported Discharge ESD RCT |
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |