StrokePhase 2/3NCT00849303
Multicenter Rehabilitation Study in Acute Stroke
A Phase 2/3 study testing gait-oriented rehabilitation in people with Stroke, run by University of Jyvaskyla at 4 sites in Finland.
Trial summary
The purpose of the first part of this study is to understand plastic brain mechanisms associated with successful gait-oriented stroke rehabilitation. Patients are randomized to receive intensive in-patient multiprofessional rehabilitation at different time points. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- gait-oriented rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesFinland
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 2/3
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first supratentorial stroke or no significant disturbance from an earlier stroke (Modified Ranking Scale, MRS 0-2)
- time since onset of stroke no more than 10 days
- Functional Ambulatory Category (FAC) 0-3
- voluntary movement in the leg of the affected side
- Barthel Index (BI) 25-75 points- no unstable cardiovascular disease
- Body Mass Index (BMI) <32
Show all 9Show fewer
- no severe malposition of joints
- no severe cognitive or communicative disorders
- no other health-related or social barriers to participate intensive rehabilitation
Who cannot join
- ICH, or MRS >2
- time since onset of stroke more than 10 days
- FAC >3
- no voluntary movement in the leg of the affected side
- BI <25 or >75
- severe malposition of joints
- severe cognitive or communicative disorders
Trial locations and contacts
4 sites in 1 country.
Finland4 sites, 4 recruiting
- Not yet recruiting
Middle Finland central hospital and Kinkomaa hospital
Jyväskylä, 40100
- Recruiting
Kuopio University Hospital
Kuopio, 70211
- Recruiting
Brain Research and Rehabilitation Center Neuron
Kuopio, 71130
- Not yet recruiting
Tampere university hospital
Tampere, 33520
About this study
Official title: Gait-Oriented Rehabilitation at Different Phases in Patients With Acute Stroke - Multicenter Randomized Controlled Trial.
The purpose of the first part of this study is to understand plastic brain mechanisms associated with successful gait-oriented stroke rehabilitation. Patients are randomized to receive intensive in-patient multiprofessional rehabilitation at different time points. One group will receive rehabilitation immediately after an acute care at the neurological clinic (8 days) and one group 5 weeks after the insult. Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy. In addition to selected parameters measuring brain plasticity, detailed assessments of functional abilities including motor ability and quality of life will be performed. A novel tool, MR-image navigated transcranial magnetic stimulation (TMS) is utilized in assessing cortical excitability in relation to stroke, time, rehabilitation, and recovery.
- Conditions
- Stroke
- Being tested
- gait-oriented rehabilitation
- Keywords
- stroke, rehabilitation, gait, timing, transcranial magnetic stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait-oriented rehabilitationOther
Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.Patients starts within 10 days since stroke onset.
gait-oriented rehabilitationOther
Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.Patients starts five weeks after stroke onset.
| Study group | Role | What they receive |
|---|---|---|
| earlier gait-oriented rehabilitation | Experimental | Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily. Receives: Other: gait-oriented rehabilitation |
| later gait-oriented rehabilitation | Active comparator | Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily. Receives: Other: gait-oriented rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulatory Category
Measured: 4 measures during six months
Barthel Index
Measured: 4 measures during 6 months
Secondary outcomes (11)
10 meters's walking speed
Measured: 4 measures during 6 months
6 minutes' walking distance
Measured: 4 measures during 6 months
Berg Balance Scale
Measured: 4 measures during 6 months
Functional Status Questionnaire
Measured: 4 measures during 6 months
Geriatric Depression Scale -15
Measured: 4 measures during 6 months
Beck Depression Intervention modified by Raitasalo
Measured: 4 measures during 6 months
Modified Motor Assessment Scale
Measured: 4 measures during 6 months
Postural sway by Good Balance
Measured: 3-4 measures during 6 months
spatio-temporal gait analysis by GaitRite
Measured: 3-4 measures during 6 months
WHOQOF-BREF
Measured: at end and at 6 months' follow-up
TMS responses (MT,MEPs,SP,SICI)
Measured: 4 measures during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Savo Hospital District, Academy of Finland, Brain Research and Rehabilitation Center Neuron (grant # 1/2009)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849303
- Sponsor's protocol ID
- 5772765
- Other IDs
- Academy of Finland 114291
- Status last verified
- Feb 2009
- First submitted
- 20 Feb 2009
- Last updated
- 23 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait-Oriented Rehabilitation at Different Phases in Patients With Acute Stroke - Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00849303
- Acronym / sponsor ID
- 5772765
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, gait, timing, transcranial magnetic stimulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- Northern Savo Hospital District, Academy of Finland, Brain Research and Rehabilitation Center Neuron (grant # 1/2009)
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (estimated)
- First posted
- 23 Feb 2009 (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.
The purpose of the first part of this study is to understand plastic brain mechanisms associated with successful gait-oriented stroke rehabilitation. Patients are randomized to receive intensive in-patient multiprofessional rehabilitation at different time points. One group will receive rehabilitation immediately after an acute care at the neurological clinic (8 days) and one group 5 weeks after the insult. Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy. In addition to selected parameters measuring brain plasticity, detailed assessments of functional abilities including motor ability and quality of life will be performed. A novel tool, MR-image navigated transcranial magnetic stimulation (TMS) is utilized in assessing cortical excitability in relation to stroke, time, rehabilitation, and recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| earlier gait-oriented rehabilitation | Experimental | Other: gait-oriented rehabilitationPatients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily. |
| later gait-oriented rehabilitation | Active comparator | Other: gait-oriented rehabilitationPatients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- first supratentorial stroke or no significant disturbance from an earlier stroke (Modified Ranking Scale, MRS 0-2)
- time since onset of stroke no more than 10 days
- Functional Ambulatory Category (FAC) 0-3
- voluntary movement in the leg of the affected side
- Barthel Index (BI) 25-75 points- no unstable cardiovascular disease
Key exclusion criteria (7 listed)
- ICH, or MRS >2
- time since onset of stroke more than 10 days
- FAC >3
- no voluntary movement in the leg of the affected side
- BI <25 or >75
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 |
|---|---|---|
| gait-oriented rehabilitationPatients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.Patients starts within 10 days since stroke onset. | Other | earlier gait-oriented rehabilitation |
| gait-oriented rehabilitationPatients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.Patients starts five weeks after stroke onset. | Other | later gait-oriented rehabilitation |
Primary outcome
Functional Ambulatory Category
Time frame: 4 measures during six months
Barthel Index
Time frame: 4 measures during 6 months
11 secondary outcomes
10 meters's walking speed
Time frame: 4 measures during 6 months
6 minutes' walking distance
Time frame: 4 measures during 6 months
Berg Balance Scale
Time frame: 4 measures during 6 months
Functional Status Questionnaire
Time frame: 4 measures during 6 months
Geriatric Depression Scale -15
Time frame: 4 measures during 6 months
Beck Depression Intervention modified by Raitasalo
Time frame: 4 measures during 6 months
Modified Motor Assessment Scale
Time frame: 4 measures during 6 months
Postural sway by Good Balance
Time frame: 3-4 measures during 6 months
spatio-temporal gait analysis by GaitRite
Time frame: 3-4 measures during 6 months
WHOQOF-BREF
Time frame: at end and at 6 months' follow-up
TMS responses (MT,MEPs,SP,SICI)
Time frame: 4 measures during 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2009.
Related trials for Stroke
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Enrolling by invitation
Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
Acute Ichemic Stroke
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
Stroke, Alzheimer s Disease
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingPhase 2
Rimonabant for Improving Walking Ability in Patients With Chronic Stroke
Chronic Stroke
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing gait-oriented rehabilitation in people with Stroke, run by University of Jyvaskyla at 4 sites 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sinikka H Peurala, PhD, PT (+358 14 260 2196, sinikka.h.peurala@jyu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Ambulatory Category (time frame: 4 measures during six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2009.