Gait Trainer vs Traditional Physiotherapy in Acute Stroke

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307762
• Other study ID #: KUH5772732
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2006
• Last updated: March 30, 2015
• Start date: May 2003
• Est. completion date: September 2007

Study information

• Verified date: January 2008
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Supratentorial stroke within 8 days of onset

• Barthel index 25-75

Exclusion Criteria:

• Severe cognitive disorder

• Severe cardiac disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patients With Acute Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Finland	Department of Neurology, University Hospital of Kuopio	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement ín motor function among patients in each group
Secondary	Modified Motor Assessment Scale (MMAS)
Secondary	Rivermead Motor Assessment Scale (RMA)
Secondary	Rivermead Mobility Index (RMI)
Secondary	Ten meters walking time (10MWT)
Secondary	Six-min walking distance
Secondary	Barthel index
Secondary	NIHSS