Patients With Acute StrokePhase 3NCT00307762
Gait Trainer vs Traditional Physiotherapy in Acute Stroke
A Phase 3 study testing intensified gait trainer in people with Patients With Acute Stroke, run by Kuopio University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patients With Acute Stroke
- What is being tested?
- intensified gait trainer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFinland
- Study dates
- May 2003to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Supratentorial stroke within 8 days of onset
- Barthel index 25-75
Who cannot join
- Severe cognitive disorder
- Severe cardiac disease
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Neurology, University Hospital of Kuopio
Kuopio, 70210
About this study
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)
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.
Read the 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.
- Conditions
- Patients With Acute Stroke
- Being tested
- intensified gait trainer
- Keywords
- Stroke, Physiotherapy, Effectiveness, Gait trainer
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensified gait trainerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Gait trainer exercise actively for 20 minutes + 55 minutes other gait-oriented physiotherapy Receives: Behavioral: intensified gait trainer |
| 2 | Active comparator | Overground walking exercises actively for 20 minutes + 55 minutes other gait-oriented physiotherapy Receives: Behavioral: intensified gait trainer |
| 3 | No intervention | Control patients with ordinary therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement ín motor function among patients in each group
Secondary outcomes (7)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startMay 2003
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sivenius MR Sivenius, MD, PhD, Study director, Department of Neurology, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307762
- Sponsor's protocol ID
- KUH5772732
- Status last verified
- Jan 2008
- First submitted
- 27 Mar 2006
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17943675
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00307762
- Acronym / sponsor ID
- KUH5772732
- Conditions
- Patients With Acute Stroke
- Keywords
- Stroke, Physiotherapy, Effectiveness, Gait trainer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Sep 2007 (actual)
- First posted
- 28 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: intensified gait trainerGait trainer exercise actively for 20 minutes + 55 minutes other gait-oriented physiotherapy |
| 2 | Active comparator | Behavioral: intensified gait trainerOverground walking exercises actively for 20 minutes + 55 minutes other gait-oriented physiotherapy |
| 3 | No intervention | –Control patients with ordinary therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Supratentorial stroke within 8 days of onset
- Barthel index 25-75
Key exclusion criteria (2 listed)
- Severe cognitive disorder
- Severe cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensified gait trainerIntensity 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. | Behavioural | 1, 2 |
Primary outcome
Improvement ín motor function among patients in each group
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Derived from this study: PubMed 17943675Peurala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sivenius MR Sivenius, MD, PhD study director
Department of Neurology, Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intensified gait trainer in people with Patients With Acute Stroke, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement ín motor function among patients in each group. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00307762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.