Gait Trainer vs Traditional Physiotherapy in Acute Stroke

March 30, 2015 updated by: Kuopio University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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  • Since the start of study, ten (10) patients have withdrawn from the study from various reasons (drop outs).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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70210
        • Department of Neurology, University Hospital of Kuopio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Supratentorial stroke within 8 days of onset
  • Barthel index 25-75

Exclusion Criteria:

  • Severe cognitive disorder
  • Severe cardiac disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Gait trainer exercise actively for 20 minutes + 55 minutes other gait-oriented physiotherapy
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.
Active Comparator: 2
Overground walking exercises actively for 20 minutes + 55 minutes other gait-oriented physiotherapy
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.
No Intervention: 3
Control patients with ordinary therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement ín motor function among patients in each group

Secondary Outcome Measures

Outcome Measure
Barthel index
Modified Motor Assessment Scale (MMAS)
Rivermead Motor Assessment Scale (RMA)
Rivermead Mobility Index (RMI)
Ten meters walking time (10MWT)
Six-min walking distance
NIHSS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Investigators

  • Study Director: Sivenius MR Sivenius, MD, PhD, Department of Neurology, Kuopio University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5772732

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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