Gait Trainer vs Traditional Physiotherapy in Acute Stroke
Primary Purpose
Patients With Acute Stroke
Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
intensified gait trainer
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Acute Stroke focused on measuring Stroke, Physiotherapy, Effectiveness, Gait trainer
Eligibility Criteria
Inclusion Criteria: Supratentorial stroke within 8 days of onset Barthel index 25-75 Exclusion Criteria: Severe cognitive disorder Severe cardiac disease
Sites / Locations
- Department of Neurology, University Hospital of Kuopio
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
1
2
3
Arm Description
Gait trainer exercise actively for 20 minutes + 55 minutes other gait-oriented physiotherapy
Overground walking exercises actively for 20 minutes + 55 minutes other gait-oriented physiotherapy
Control patients with ordinary therapy
Outcomes
Primary Outcome Measures
Improvement ín motor function among patients in each group
Secondary Outcome Measures
Modified Motor Assessment Scale (MMAS)
Rivermead Motor Assessment Scale (RMA)
Rivermead Mobility Index (RMI)
Ten meters walking time (10MWT)
Six-min walking distance
Barthel index
NIHSS
Full Information
NCT ID
NCT00307762
First Posted
March 27, 2006
Last Updated
March 30, 2015
Sponsor
Kuopio University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00307762
Brief Title
Gait Trainer vs Traditional Physiotherapy in Acute Stroke
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kuopio University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Acute Stroke
Keywords
Stroke, Physiotherapy, Effectiveness, Gait trainer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Gait trainer exercise actively for 20 minutes + 55 minutes other gait-oriented physiotherapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Overground walking exercises actively for 20 minutes + 55 minutes other gait-oriented physiotherapy
Arm Title
3
Arm Type
No Intervention
Arm Description
Control patients with ordinary therapy
Intervention Type
Behavioral
Intervention Name(s)
intensified gait trainer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement ín motor function among patients in each group
Secondary Outcome Measure Information:
Title
Modified Motor Assessment Scale (MMAS)
Title
Rivermead Motor Assessment Scale (RMA)
Title
Rivermead Mobility Index (RMI)
Title
Ten meters walking time (10MWT)
Title
Six-min walking distance
Title
Barthel index
Title
NIHSS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Supratentorial stroke within 8 days of onset
Barthel index 25-75
Exclusion Criteria:
Severe cognitive disorder
Severe cardiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sivenius MR Sivenius, MD, PhD
Organizational Affiliation
Department of Neurology, Kuopio University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neurology, University Hospital of Kuopio
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
17943675
Citation
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.
Results Reference
derived
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Gait Trainer vs Traditional Physiotherapy in Acute Stroke
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