StrokeNCT00604747
Practice Structure on Motor Learning in Post-Stroke Patients
A study testing Structure practice in people with Stroke, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Background: The literature indicates that, in relation to motor learning, healthy subjects benefit more from random practice than from constant practice. However, this effect is not well known in post-stroke patients. Read more about this study
- Who is it for?
- Ages 40 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Structure practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2006to Jul 2007
- Phase
- Interventional
- 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 40 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- First cerebrovascular accident
- Lesion covering the middle and the anterior cerebral artery territories
- Presence of hemiplegia or hemiparesis
- Mini-Mental State Examination (MMSE) score above 24 (19)
- Sufficient attention and comprehension to perform the task
- Absence of other associated neurological diseases.
Who cannot join
- Acute medical problems
- Uncorrected vision loss
- Previous history of psychiatric admission
- History of multiple strokes, transient ischemic attacks
- Pathology of the less affected, ipsilateral to stroke upper extremity that would affect ability to perform the task
- Score of 23 or less on the MMSE
- Difficulty in comprehension of verbal command and simple instructions
- Aphasia of comprehension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Practice Structure on Motor Learning in Post-Stroke Patients
Background: The literature indicates that, in relation to motor learning, healthy subjects benefit more from random practice than from constant practice. However, this effect is not well known in post-stroke patients. Objective: The goal of this study was to investigate the effects of practice structure on motor learning in post-stroke patients. Methods: Participants included an experimental group (EG) of post-stroke patients: 17 males and females; and a control group (CG) of healthy individuals: 17 males and females. At the acquisition phase, all participants performed 30 trials of a coincident timing task. Nine individuals from each group practiced constantly (C) at a stimulus propagation speed of 3 mph, and eight from each group practiced randomly (R) at speeds of 2, 3, and 5 mph. Subsequent phases included: 1) transfer, 2) retention after 15 minutes, and 3) retention after 3 days. Each of these phases included 20 trials: 10 at a speed of 1 mph, and 10 at a speed of 4 mph. Intra- and inter-group comparisons were made employing an alpha level of 0.05 (5%).
Read the detailed description
Utilized was Bassin's anticipation timer (Lafayette Instruments #50575), which is comprised of a control screen, one 1.52 m gutter with 32 diodes placed on it linearly, and a response button. The screen has a digital display, with commands that permit the operator to control the stimulus propagation speed and the preparatory interval speed. Once activated, the screen exhibits an alert signal, and, after the preparatory interval, it initiates the propagation of a luminous stimulus, lighting the 32 diodes successively. The task required participants to press the response button simultaneously with the illumination of the last diode. The digital display showed the error measure (em): that is, the difference between the illumination of the last diode and the response.
- Conditions
- Stroke
- Being tested
- Structure practice
- Keywords
- motor learning, hemiplegia, stroke, practice, physiotherapy
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structure practiceOther
Also called experimental group (EG), control group (CG)
there were 2 groups which received random practice and constant practice during acquisition phase
| Study group | Role | What they receive |
|---|---|---|
| 1, 2 | Other | Not described Receives: Other: Structure practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in performance during the acquisition; performance exhibited during the transfer phase was maintained during retention phases 1 and 2; and differences between the groups during the transfer phase and retention phases
Measured: time in miliseconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startAug 2006
- Primary completionJul 2007
- Study completionJul 2007
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Camila Torriani, Principal investigator, University of Sao PauloCamila Torriani, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604747
- Sponsor's protocol ID
- 0038.0.254.000-05
- Other IDs
- 0038.0.254.000-05
- Status last verified
- Jan 2008
- First submitted
- 17 Jan 2008
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Practice Structure on Motor Learning in Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT00604747
- Acronym / sponsor ID
- 0038.0.254.000-05
- Conditions
- Stroke
- Keywords
- motor learning, hemiplegia, stroke, practice, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 30 Jan 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.
Background: The literature indicates that, in relation to motor learning, healthy subjects benefit more from random practice than from constant practice. However, this effect is not well known in post-stroke patients. Objective: The goal of this study was to investigate the effects of practice structure on motor learning in post-stroke patients. Methods: Participants included an experimental group (EG) of post-stroke patients: 17 males and females; and a control group (CG) of healthy individuals: 17 males and females. At the acquisition phase, all participants performed 30 trials of a coincident timing task. Nine individuals from each group practiced constantly (C) at a stimulus propagation speed of 3 mph, and eight from each group practiced randomly (R) at speeds of 2, 3, and 5 mph. Subsequent phases included: 1) transfer, 2) retention after 15 minutes, and 3) retention after 3 days. Each of these phases included 20 trials: 10 at a speed of 1 mph, and 10 at a speed of 4 mph. Intra- and inter-group comparisons were made employing an alpha level of 0.05 (5%).
Detailed description
Utilized was Bassin's anticipation timer (Lafayette Instruments #50575), which is comprised of a control screen, one 1.52 m gutter with 32 diodes placed on it linearly, and a response button. The screen has a digital display, with commands that permit the operator to control the stimulus propagation speed and the preparatory interval speed. Once activated, the screen exhibits an alert signal, and, after the preparatory interval, it initiates the propagation of a luminous stimulus, lighting the 32 diodes successively. The task required participants to press the response button simultaneously with the illumination of the last diode. The digital display showed the error measure (em): that is, the difference between the illumination of the last diode and the response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, 2 | Other | Other: Structure practice |
Who may qualify
- Ages
- 40 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- First cerebrovascular accident
- Lesion covering the middle and the anterior cerebral artery territories
- Presence of hemiplegia or hemiparesis
- Mini-Mental State Examination (MMSE) score above 24 (19)
- Sufficient attention and comprehension to perform the task
Key exclusion criteria (8 listed)
- Acute medical problems
- Uncorrected vision loss
- Previous history of psychiatric admission
- History of multiple strokes, transient ischemic attacks
- Pathology of the less affected, ipsilateral to stroke upper extremity that would affect ability to perform the task
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 |
|---|---|---|
| Structure practiceAlso: experimental group (EG), control group (CG)there were 2 groups which received random practice and constant practice during acquisition phase | Other | 1, 2 |
Primary outcome
change in performance during the acquisition; performance exhibited during the transfer phase was maintained during retention phases 1 and 2; and differences between the groups during the transfer phase and retention phases
Time frame: time in miliseconds
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 30 Jan 2008.
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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 principal investigator
University of Sao Paulo
Camila Torriani 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?
A study testing Structure practice in people with Stroke, run by University of Sao Paulo 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 6 inclusion and 8 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 30 Jan 2008. 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?
change in performance during the acquisition; performance exhibited during the transfer phase was maintained during retention phases 1 and 2; and differences between the groups during the transfer phase and retention phases (time frame: time in miliseconds). 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 30 Jan 2008.