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| Name | Class |
|---|---|
| University of Bergen | OTHER |
| Municipality of Bergen, Norway | UNKNOWN |
| Kavli Research Centre for Ageing and Dementia | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Day unit rehabilitation | 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. |
|
| Home rehabilitation | 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. |
|
| Treatment as usual | No Intervention | Patients will receive rehabilitation treatment after today's principles and routines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early supported discharge with day unit rehabilitation | Other | Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRS | Modified Rankin Scale | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS | National Institutes of Health Stroke Scale | 3, 6 and 12 months |
| BI | Barthel ADL Index | 3, 6, 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan S. Skouen, PhD | Haukeland University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | N-5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22594689 | Background | Hofstad H, Naess H, Moe-Nilssen R, Skouen JS. Early supported discharge after stroke in Bergen (ESD Stroke Bergen): a randomized controlled trial comparing rehabilitation in a day unit or in the patients' homes with conventional treatment. Int J Stroke. 2013 Oct;8(7):582-7. doi: 10.1111/j.1747-4949.2012.00825.x. Epub 2012 May 18. | |
| 22191850 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Early supported discharge with home rehabilitation | Other | Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in the patient's home |
|
| AMPS | Assessment of Motor and Process Skills | 3 and 6 months |
| TIS | Trunk Impairment Scale | 3 and 6 months |
| SIS | Stroke Impact Scale | 12 months |
| RSS | Relative Stress Scale | 12 months |
| PGIC | Patients' Global Impression of Change | 12 and 24 months |
| SF-36 | Short Form (36) Health Survey | 12 and 24 months |
| MRS | Modified Rankin Scale | 3, 12 and 24 months |
| PASS (Postural Assessment Scale for Stroke) | 3 and 6 months |
| 5mTW (5 meter Timed Walk) | 3 and 6 months |
| TUG (Timed Up and Go) | 3 and 6 months |
| NRS (Numeric Rating Scale) | 3 and 6 months |
| Norwegian Basic Test for Aphasia | 3 and 12 months |
| Gjelsvik B, Breivik K, Verheyden G, Smedal T, Hofstad H, Strand LI. The Trunk Impairment Scale - modified to ordinal scales in the Norwegian version. Disabil Rehabil. 2012;34(16):1385-95. doi: 10.3109/09638288.2011.645113. Epub 2011 Dec 23. |
| 25528166 | Derived | Hofstad H, Gjelsvik BE, Naess H, Eide GE, Skouen JS. Early supported discharge after stroke in Bergen (ESD Stroke Bergen): three and six months results of a randomised controlled trial comparing two early supported discharge schemes with treatment as usual. BMC Neurol. 2014 Dec 21;14:239. doi: 10.1186/s12883-014-0239-3. |
| 24833680 | Derived | Gjelsvik BE, Hofstad H, Smedal T, Eide GE, Naess H, Skouen JS, Frisk B, Daltveit S, Strand LI. Balance and walking after three different models of stroke rehabilitation: early supported discharge in a day unit or at home, and traditional treatment (control). BMJ Open. 2014 May 14;4(5):e004358. doi: 10.1136/bmjopen-2013-004358. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |