Efficacy of Task-specific Training on Physical Activity Levels Post-stroke
NCT ID: NCT02937480
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2016-06-30
2018-08-31
Brief Summary
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Detailed Description
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Data analyses will be performed by the SPSS for Windows® (release 17.0, SPSS Inc., Chicago, IL, USA). Descriptive statistics will be carried-out for all outcome variables. Differences between the groups at baseline will be investigated with the independent Student's t-tests for all variables related to the demographic and clinical characteristics. If differences between the groups at baseline exist, analysis of covariance will be used to eliminate the influence of extraneous factors.
The effects of the interventions will be analysed in two ways, namely from the data collected and by intention-to-treat analyses, where the last available value in the dropouts will be carried forward to represent the missing data. Analyses of variance with repeated measures (2×4) will be employed to investigate the mean and interaction effects between the groups (intervention×control) and the time (preintervention, postintervention, and follow-up) for the primary and secondary outcomes. Group descriptions will be presented as mean (SD) and effect sizes with 95% confidence intervals (CIs) will be reported.
The effect sizes will be calculated to determine the magnitude of the differences between the groups. The differences between the two mean values will be expressed in units of their SD, expressed as Cohen's d, or mean results for the experimental group minus the mean results for the control group, divided by the SD of the control group. Effect sizes between 0.2 and 0.5 will be considered small; between 0.5 and 0.8, medium; and above 0.8, large.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group
Task-specific training
Task-specific training
The task-specific training will be composed by 30 minutes for upper limb and 30 minutes for lower limb tasks. Subjects will performed five minutes of exercise in each station of the circuit and only the last station will last 10 minutes and will involve a walking training with auditory stimulation. Individuals will be encouraged to work as hard as possible at each station and verbal feedback and instructions aimed at improving performance will be taken. Between each task, the participants will be allowed to rest for at least 1-2 minutes, and individual adjustments will be carried out for better adaptations to the training.
Control group
Global stretching, memory exercises, health care orientation
Global stretching, memory exercises, health care orientation
The control intervention will be composed by 40 minutes for global stretching, 20 minutes of memory exercises and health care orientation
Interventions
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Task-specific training
The task-specific training will be composed by 30 minutes for upper limb and 30 minutes for lower limb tasks. Subjects will performed five minutes of exercise in each station of the circuit and only the last station will last 10 minutes and will involve a walking training with auditory stimulation. Individuals will be encouraged to work as hard as possible at each station and verbal feedback and instructions aimed at improving performance will be taken. Between each task, the participants will be allowed to rest for at least 1-2 minutes, and individual adjustments will be carried out for better adaptations to the training.
Global stretching, memory exercises, health care orientation
The control intervention will be composed by 40 minutes for global stretching, 20 minutes of memory exercises and health care orientation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* are older than 19 years of age;
* are able to independently walk 10 m with or without walking aid devices;
* have tone of elbow flexor muscles below 4 on modified Ashworth scale;
* are inactive or insufficient, based on Centers for Disease Control and Prevention criteria;
* get medical permission for physical activity practice
Exclusion Criteria
* have history of severe heart disease and/or uncontrolled blood pressure;
* have pain and/or other adverse health conditions which might affect the performance in the intervention program, such as vestibular disturbances, severe arthritis, or other neurological disorders.
20 Years
ALL
No
Sponsors
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Fundação de Amparo à Pesquisa do estado de Minas Gerais
OTHER
Federal University of Minas Gerais
OTHER
Responsible Party
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Christina Danielli Coelho de Morais Faria
Doctor
Principal Investigators
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Christina Danielli CM Faria, Doctor
Role: PRINCIPAL_INVESTIGATOR
Federal University of Minas Gerais
Locations
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Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Countries
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References
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Other Identifiers
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CAAE: 51453915.1.0000.5149
Identifier Type: -
Identifier Source: org_study_id