Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001077954
Ethics application status
Approved
Date submitted
8/02/2011
Date registered
18/10/2011
Date last updated
18/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Motor learning after stroke
Scientific title
Comparison between Motor learning in stroke and healthy subjects
Secondary ID [1] 253566 0
Nil
Universal Trial Number (UTN)
U1111-1119-3625
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subjects post stroke 261123 0
Condition category
Condition code
Stroke 259275 259275 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Motor learning design: practice of 50 trials (in the same day - duration of 30 minutes of practice - this 30 minutes duration is the total time to perform all 50 trials) with a maze task with paper and pen. The purpose of the task is to find out the exit from the begining of the maze, considering that there is only one way to find the exit from the entrance. All the subjects, including the stroke patients performed 50 trials of the maze task and time was the variable measured. This phase was nominated acquisition phase in which the subject practice the task to acquire a better performance. Then, they were retested in diferent conditions: two retention tests (after 15 minutes and 3 days) and also transference test - after the second retention test (considering some changes in the maze, so that they needed to adapt their performances to obtain sucess in the task. All the data was analysed considering blocks of 5 trials, so that in acquisition phase there was 10 blocks of 5 trials, and in the tests (retention- 15 minutes and 3 days later - and transference) there 2 blocks of 5 trials each.
Intervention code [1] 257996 0
Not applicable
Comparator / control treatment
The same intervention applied to the control group (healthy subjects)
Control group
Active

Outcomes
Primary outcome [1] 262090 0
total time to complete the maze task (in seconds)
Timepoint [1] 262090 0
According to the phases established (acquisition phase and retention and transfer test) each of these phases were composed by trials in which the subjects performed the task. So timepoint (for analysis purposes) was defined: last block of 5 trials in acquisition phase, and the blocks of 5 trials from the retention and transfer tests.
Primary outcome [2] 262266 0
total time to complete the maze task (in seconds)
Timepoint [2] 262266 0
According to the phases established (acquisition phase and retention and transfer test) each of these phases were made by trials in which the subjects performed the task. So timepoint (for analysis purposes) was defined: last block of 5 trials in acquisition phase, and the blocks of 5 trials from the retention and transfer tests.
Secondary outcome [1] 273793 0
Nil
Timepoint [1] 273793 0
Nil

Eligibility
Key inclusion criteria
Chronic stroke, single ictus, MEMS at least 23 points, no comprehension disorder, right handed.
Healthy group was matched by age and gender with the experimental group, so there was no key inclusion criteria because they wre age-gender matched to the experimental group.
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aphasia, clinical instability, other neurological condition (i.e. Parkinson Disease, Alzheimer).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3171 0
Brazil
State/province [1] 3171 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 258454 0
Self funded/Unfunded
Name [1] 258454 0
Country [1] 258454 0
Brazil
Primary sponsor type
University
Name
Sao Paulo University
Address
Av Prof Mello Moraes 65 Cidade Universitaria Sao Paulo-SP CEP 05508-030
Country
Brazil
Secondary sponsor category [1] 257597 0
University
Name [1] 257597 0
United Metropolitan University
Address [1] 257597 0
Av Santo Amaro 1239 Vila Nova Conceicao Sao Paulo-SP CEP 04506-000
Country [1] 257597 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260435 0
University of the City of Sao Paulo Ethics Committee
Ethics committee address [1] 260435 0
Rua Cesareo Galeno 448- Vila Carrao Sao Paulo-SP CEP 03071-000
Ethics committee country [1] 260435 0
Brazil
Date submitted for ethics approval [1] 260435 0
12/11/2008
Approval date [1] 260435 0
02/03/2009
Ethics approval number [1] 260435 0
13363343

Summary
Brief summary
BACKGROUND: Stroke is the main disease which leads to disability in several countries in the world and it is caused by interruption of blood flow to brain, rupture of a blood vessel or occlusion with a clot. This interruption cause much damage to nervous tissue varying according to the lesioned area and extension. Recent studies indicate that, in regards to the local of the lesion, stroke subjects have difficulty on motor skills learning when compared to healthy subjects. OBJECTIVE: Investigating motor skill learning in subjects after stroke and comparing them to healthy subjects. METHOD: 40 subjects participated of this study divided in two groups: experimental group (EG) and control group (CG), where both groups performed a maze task with pen and paper. This study consisted of acquisition phase (AQ) and transfer tests (TR) and retention at short (R1) and long term (R2). Dependent variable was total time for performing this action. RESULTS: Intragroup analysis showed both groups improved with practice. Intergroup analysis (CGxEG) detected significant differences in all learning tests, indicating inferiority of EG when compared to CG. CONCLUSION: Post-stroke subjects are able to learn a motor skill, but they reached an inferior performance when compared to CG.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 32188 0
Address 32188 0
Country 32188 0
Phone 32188 0
Fax 32188 0
Email 32188 0
Contact person for public queries
Name 15435 0
Camila Torriani-Pasin
Address 15435 0
Av Prof Melo Moraes , 65 - Cidade Universitaria Sao Paulo-SP CEP 05508-030
Country 15435 0
Brazil
Phone 15435 0
55 11 32973954
Fax 15435 0
Email 15435 0
[email protected]
Contact person for scientific queries
Name 6363 0
Camila Torriani-Pasin
Address 6363 0
Av Prof Melo Moraes , 65 - Cidade Universitaria Sao Paulo-SP CEP 05508-030
Country 6363 0
Brazil
Phone 6363 0
55 11 32973954
Fax 6363 0
Email 6363 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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