Gait Trainer vs Traditional Physiotherapy in Acute Stroke
Condition: Patients With Acute Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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        -  Since the start of study, ten (10) patients have withdrawn from the study from various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.
    

Intervention name(s): intensified gait trainer
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Physiotherapy; Effectiveness; Gait trainer