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This is a trial aiming to evaluate the difference of effectiveness between two therapy methods in patients with acute stroke. The other aim is to use Navigated Brain Stimulation (NBS)to analyze changes in brain networks during the recovery and as the consequence of rehabilitation. The groups are:
This study has been started in 2003 as a randomized study comparing rehabilitation with gait trainer and traditional gait-oriented physiotherapy.
* From the beginning of 2005, all patients have been evaluated using NBS (Navigating Brain Stimulation), a magnetic stimulation device. This stimulation is performed on day 3, 10 and 15 and at 6 months.
The idea of combining navigated magnetic brain stimulation (NBS)in the rehabilitation intervention study is to evaluate the change in brain networks during the recovery process, to see possible differences in these networks due to different rehabilitation methods and/or good vs. poor recovery. In connection with the magnetic stimulation, a 60-channel EEG map will be taken in order to measure the electrical spread of the induced neural electrical activity, which describes the state of the connections of the damaged brain area to other parts of the brain as well as of possible activation of new neural connections.
This arrangement allows a unique opportunity to study the re-organisation of brain structures after stroke and brain plasticity in general in recovering brain.
For the evaluation of functional recovery, a combination of relevant scales of motor function will be measured during the study. Those are: Rivermead Mobility Index, Rivermead Motor Assessment , Modified Motor Assessment Scale, Functional ambulation Category, Physical Cost Index, 6-minute walking time. In addition, Barthel index, Scandinavian Stroke Scale and NIH Scale will be performed in the beginning and at the end.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Gait trainer exercise actively for 20 minutes + 55 minutes other gait-oriented physiotherapy |
|
| 2 | Active Comparator | Overground walking exercises actively for 20 minutes + 55 minutes other gait-oriented physiotherapy |
|
| 3 | No Intervention | Control patients with ordinary therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensified gait trainer | Behavioral | Intensity and type of rehabilitation after stroke. Gait trainér + or overground walking + other gait-oriented physioteharpy. The third group (control patients) received traditional (ordinary) physiotherapy witn o efforts to intensify it. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement Ãn motor function among patients in each group |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Motor Assessment Scale (MMAS) | ||
| Rivermead Motor Assessment Scale (RMA) | ||
| Rivermead Mobility Index (RMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sivenius MR Sivenius, MD, PhD | Department of Neurology, Kuopio University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, University Hospital of Kuopio | Kuopio | 70210 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17943675 | Derived | Peurala SH, Airaksinen O, Jakala P, Tarkka IM, Sivenius J. Effects of intensive gait-oriented physiotherapy during early acute phase of stroke. J Rehabil Res Dev. 2007;44(5):637-48. doi: 10.1682/jrrd.2006.05.0039. |
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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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| Ten meters walking time (10MWT) |
| Six-min walking distance |
| Barthel index |
| NIHSS |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |