Patients With Acute Stroke Clinical Trial
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)
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:
- body-weight supported gate trainer rehabilitation
- gait-oriented traditional physiotherapy Patients in physiotherapy group will have 75
min physiotherapy daily every workday. This includes 20 minutes walking exercises in
the traditional group while 20 minutes of gait trainer therapy in the gait trainer
group. 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.
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 total number of patients recruited in the study is 57, seventeen (17) patients in
gait trainer group and twenty (20) patients in the group of traditional physiotherapy.
From the year 2005 onwards, ten (10 control patients have been recruited. Those
patients have been selected with the exactly the same criteria as those who have been
included in the treatment groups. The control patients have exactly the same
evaluations at same time points, but their rehabilitation takes place according to the
principles obeyed in the neurology clinic. Thus, they have not been randomised in any
of the two treatment groups.
- Since the start of study, ten (10) patients have withdrawn from the study from various
reasons (drop outs). 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.
- Thus, the final group consists of 17 patients in the gait trainer group, 20 patients in
the traditional therapy group and 10 patients in the control group.
- There will be 25 patients who have underwent the whole procedure of NBS: 9 patients in
the gait trainer group, 8 patients in the traditional therapy group and 8 patients in
the control group. The last 6-month follow-ups will take place in late August/early
September 2007.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment