Cerebrovascular AccidentPhase 3NCT00172484
North Taiwan Stroke Center for Prevention and Treatment
A Phase 3 study testing education program, nursing program and rehabilitation program in people with Cerebrovascular Accident, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The Northern Taiwan Stroke Center for Prevention and Treatment Project is a single medical center, 3-year, multipurpose study. The aims of this study are (1) to set up a multidisciplinary stroke team in a well-designed stroke center for stroke care; (2) to establish a systemic stroke prevention / education protocol… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- education program, nursing program and rehabilitation program
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2005to Dec 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute stroke
- age > 18 y/o
- consult rehabilitation
- client or agent can sign a letter of consent
Who cannot join
- contraindication of electrical stimulation(pacemaker implant, severe arrhythmia, malignant cancer, wound on stimulation site)
Trial locations and contacts
1 site in 1 country.
About this study
The Northern Taiwan Stroke Center for Prevention and Treatment Project is a single medical center, 3-year, multipurpose study. The aims of this study are (1) to set up a multidisciplinary stroke team in a well-designed stroke center for stroke care; (2) to establish a systemic stroke prevention / education protocol based on people's awareness of stroke; and (3) to create a better stroke rehabilitation protocol and pathway.there are three components in rehabilitation projects. First, we want to identify potential factors related to functional outcome in patients with stroke before and after stroke center. Second, we want to compare the functional outcome in patients who admit to the stroke center as to those admitted to the general ward. Third, we want to investigate the effect of electrical stimulation on upper limb function in patient with acute stroke.
- Conditions
- Cerebrovascular Accident
- Being tested
- education program, nursing program, rehabilitation program
- Keywords
- cerebrovascular accident, stroke center, stroke team, intensive care of stroke, rehabilitation of stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education programProcedure or surgery
A well-designed questionnaire concerning about awareness of stroke symptoms, knowledge, and management was done in adults of stroke victims' family members and general population.
nursing programProcedure or surgery
To establish a systemic stroke prevention, education protocol
rehabilitation programProcedure or surgery
From a sample of 648 stroke patients who were referred to rehabilitation between November 2002 and October 2002, 345 charts were successfully reviewed. Besides, 126 subjects were randomly selected and successfully contacted for telephone follow-up; and data from 87 subjects of telephone survey were included for statistical analysis. Comparison of functional status between early rehabilitation and ordinary scheduled rehabilitation for acute stroke patients was done from admission to 3 months after stroke onset. The efficacy of early application of electric stimulation for the upper paralyzed extremity was performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bureau Of Health Promotion,Department of Health , R.O.C.
Measured: 2003/08/29；2004/02/02；2004/08/26；2004/12/03；2005/06/12；2005/11/22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping-Keung Yip, Study chair, Department of Neurology, National Taiwan Univisity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172484
- Sponsor's protocol ID
- 9361700808
- Status last verified
- Nov 2012
- First submitted
- 12 Sep 2005
- Last updated
- 16 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- North Taiwan Stroke Center for Prevention and Treatment
- ClinicalTrials.gov ID
- NCT00172484
- Acronym / sponsor ID
- 9361700808
- Conditions
- Cerebrovascular Accident
- Keywords
- cerebrovascular accident, stroke center, stroke team, intensive care of stroke, rehabilitation of stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 15 Sep 2005 (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 Northern Taiwan Stroke Center for Prevention and Treatment Project is a single medical center, 3-year, multipurpose study. The aims of this study are (1) to set up a multidisciplinary stroke team in a well-designed stroke center for stroke care; (2) to establish a systemic stroke prevention / education protocol based on people's awareness of stroke; and (3) to create a better stroke rehabilitation protocol and pathway.there are three components in rehabilitation projects. First, we want to identify potential factors related to functional outcome in patients with stroke before and after stroke center. Second, we want to compare the functional outcome in patients who admit to the stroke center as to those admitted to the general ward. Third, we want to investigate the effect of electrical stimulation on upper limb function in patient with acute stroke.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute stroke
- age > 18 y/o
- consult rehabilitation
- client or agent can sign a letter of consent
Key exclusion criteria (1 listed)
- contraindication of electrical stimulation(pacemaker implant, severe arrhythmia, malignant cancer, wound on stimulation site)
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 |
|---|---|---|
| education programA well-designed questionnaire concerning about awareness of stroke symptoms, knowledge, and management was done in adults of stroke victims' family members and general population. | Procedure or surgery | – |
| nursing programTo establish a systemic stroke prevention, education protocol | Procedure or surgery | – |
| rehabilitation programFrom a sample of 648 stroke patients who were referred to rehabilitation between November 2002 and October 2002, 345 charts were successfully reviewed. Besides, 126 subjects were randomly selected and successfully contacted for telephone follow-up; and data from 87 subjects of telephone survey were included for statistical analysis. Comparison of functional status between early rehabilitation and ordinary scheduled rehabilitation for acute stroke patients was done from admission to 3 months after stroke onset. The efficacy of early application of electric stimulation for the upper paralyzed extremity was performed. | Procedure or surgery | – |
Primary outcome
Bureau Of Health Promotion,Department of Health , R.O.C.
Time frame: 2003/08/29；2004/02/02；2004/08/26；2004/12/03；2005/06/12；2005/11/22
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 16 Nov 2012.
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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.
Ping-Keung Yip study chair
Department of Neurology, National Taiwan Univisity 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 education program, nursing program and rehabilitation program in people with Cerebrovascular Accident, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 1 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 16 Nov 2012. 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 Taiwan. 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?
Bureau Of Health Promotion,Department of Health , R.O.C. (time frame: 2003/08/29；2004/02/02；2004/08/26；2004/12/03；2005/06/12；2005/11/22). 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 16 Nov 2012.