Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307762
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2006-03-27
Brief Title:
Gait Trainer vs Traditional Physiotherapy in Acute Stroke
Sponsor:
Kuopio University Hospital
Organization:
Kuopio University Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 NBSto 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
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 Augustearly September 2007
The idea of combining navigated magnetic brain stimulation NBSin 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 andor 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
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 Augustearly September 2007
The idea of combining navigated magnetic brain stimulation NBSin 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None