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Sponsored by: |
Kuopio University Hospital |
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Information provided by: | Kuopio University Hospital |
ClinicalTrials.gov Identifier: | NCT00307762 |
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:
The evaluation of effectiveness of therapy in each group is made after three weeks' therapy and at six months.
The goal is to have 40 patients until the end of June 2006.
Condition | Intervention | Phase |
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Patients With Acute Stroke |
Behavioral: intensified gait trainer |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Body-Weight Supported Therapy Using Gait Trainer Versus Traditional Gait-Oriented Physiotherapy in Acute Phase of Stroke. The Effectiveness of Gait Training and Brain Networks Using NBS (Navigating Brain Stimulation) |
Enrollment: | 57 |
Study Start Date: | May 2003 |
Study Completion Date: | September 2007 |
Arms | Assigned Interventions |
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1: Experimental
Gait trainer exercise actively for 20 minutes + 55 minutes other gait-oriented physiotherapy
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Behavioral: intensified gait trainer
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.
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2: Active Comparator
Overground walking exercises actively for 20 minutes + 55 minutes other gait-oriented physiotherapy
|
Behavioral: intensified gait trainer
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.
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3: No Intervention
Control patients with ordinary therapy
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Behavioral: intensified gait trainer
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.
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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.
One patient before randomization, 5 patients in the gait trainer group, one patient in the traditional physiotherapy group and 3 patients in the control group.
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Finland | |
Department of Neurology, University Hospital of Kuopio | |
Kuopio, Finland, 70210 |
Study Director: | Sivenius MR Sivenius, MD, PhD | Department of Neurology, Kuopio University Hospital |
Study ID Numbers: | KUH5772732 |
Study First Received: | March 27, 2006 |
Last Updated: | January 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00307762 History of Changes |
Health Authority: | Finland: Ministry of Social Affairs and Health |
Stroke Physiotherapy Effectiveness Gait trainer |
Body Weight Cerebral Infarction Stroke Vascular Diseases Brain Ischemia Central Nervous System Diseases |
Ischemia Brain Infarction Brain Diseases Infarction Cerebrovascular Disorders |
Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Brain Ischemia |
Central Nervous System Diseases Cardiovascular Diseases Brain Infarction Brain Diseases Cerebrovascular Disorders |