StrokeNCT00740402
Motor Learning of a Planning Task in Stroke Patients: the Maze Paradigm Measured Through Time and Error as Variables
An observational study of Stroke, run by Faculdades Metropolitanas Unidas at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate the process of acquiring a motor skill subject in post-stroke, comparing them with healthy subjects. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Jan 2009
- Phase
- Observational
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients after stroke
Who may be able to join
- Age between 40 and 65
- Injury in territory of movement earlier, as shown by examination of image and finding medical neurologist
- Time of injury over 6 months
- Single vascular event
- Right handed, by applying the Inventory of Dominance Side of Edinburgh Mini mental with scores over 23 points
Who cannot join
- Aphasia of understanding
- Instability clinic
- Other neurological diseases associated (Parkinson's disease, dementias, Alzheimer)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor Learning of a Planning Task in Stroke Patients
The purpose of this study is to investigate the process of acquiring a motor skill subject in post-stroke, comparing them with healthy subjects.
Read the detailed description
20 post-stroke patients were comprised to the experimental group (EG) and 20 health subjects were included to the control group (CG. Inclusion criteria: chronic stroke, single stroke event, lesion in anterior circulation, right handed subjects, MEEM over 23 points. The task consisted in a maze paradigm, made by pencil and paper, with the non affected side for EG and left upper extremity for CG. The instruction was given to the subjects to complete the task as fast as possible. The study consisted in three phases: acquisition (AQ)with 30 trials, transfer (TR, short retention (R1)and long term retention (R2 both with 5 trials.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
TIME
time (in seconds)
Measured: 3 times in a week (acquisition, transfer an retention phase)
Secondary outcomes (1)
error
number of mistakes made by the subjects
Measured: 3 times in a week (acquisition, transfer an retention phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionJan 2009
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdades Metropolitanas Unidas
- Sponsor type
- University, hospital or other
- Investigators
- Camila Torriani, doctor, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740402
- Sponsor's protocol ID
- GPalma
- Other IDs
- GPalma 123
- Status last verified
- Aug 2008
- First submitted
- 22 Aug 2008
- Last updated
- 16 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Learning of a Planning Task in Stroke Patients
- ClinicalTrials.gov ID
- NCT00740402
- Acronym / sponsor ID
- GPalma
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Faculdades Metropolitanas UnidasUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 Aug 2008 (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 this study is to investigate the process of acquiring a motor skill subject in post-stroke, comparing them with healthy subjects.
Detailed description
20 post-stroke patients were comprised to the experimental group (EG) and 20 health subjects were included to the control group (CG. Inclusion criteria: chronic stroke, single stroke event, lesion in anterior circulation, right handed subjects, MEEM over 23 points. The task consisted in a maze paradigm, made by pencil and paper, with the non affected side for EG and left upper extremity for CG. The instruction was given to the subjects to complete the task as fast as possible. The study consisted in three phases: acquisition (AQ)with 30 trials, transfer (TR, short retention (R1)and long term retention (R2 both with 5 trials.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients after stroke
Key inclusion criteria (5 listed)
- Age between 40 and 65
- Injury in territory of movement earlier, as shown by examination of image and finding medical neurologist
- Time of injury over 6 months
- Single vascular event
- Right handed, by applying the Inventory of Dominance Side of Edinburgh Mini mental with scores over 23 points
Key exclusion criteria (3 listed)
- Aphasia of understanding
- Instability clinic
- Other neurological diseases associated (Parkinson's disease, dementias, Alzheimer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TIME
Time frame: 3 times in a week (acquisition, transfer an retention phase)
time (in seconds)
1 secondary outcome
error
Time frame: 3 times in a week (acquisition, transfer an retention phase)
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 Apr 2010.
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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.
Camila Torriani, doctor study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Faculdades Metropolitanas Unidas at 1 site in Brazil.
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 5 inclusion and 3 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 Apr 2010. 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 Brazil. 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.
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?
TIME (time frame: 3 times in a week (acquisition, transfer an retention phase)). 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 Apr 2010.