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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-6w9nfq |
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Date of registration:
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11/05/2012 |
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Primary sponsor: |
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Public title:
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Effects of the combination of visual or auditory cues to treadmill gait training of individuals who have suffered stroke
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Scientific title:
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Influence of biofeedback in gait training on a treadmill with partial body weight support in hemiparetic subjects |
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Date of first enrolment:
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01/07/2011 |
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Target sample size:
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30 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-6w9nfq/ |
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Study type:
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Study design:
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Therapeutic, parallel, single-blinded, with 3 arms, randomized clinical trial
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Gabriela
Gama |
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Address:
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AV. SENADOR SALGADO FILHO, 3000- Cidade universitária- departamento de fisioterapia
59072-970
Natal
Brazil |
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Telephone:
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(83) 88298003 |
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Email:
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gabilopes_@hotmail.com |
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Affiliation:
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Universidade Federal do Rio Grande do Norte - UFRN |
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Name:
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Gabriela
Gama |
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Address:
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AV. SENADOR SALGADO FILHO, 3000- Cidade universitária- departamento de fisioterapia
59072-970
Natal
Brazil |
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Telephone:
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(83) 88298003 |
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Email:
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gabilopes_@hotmail.com |
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Affiliation:
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Universidade Federal do Rio Grande do Norte - UFRN |
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Key inclusion & exclusion criteria
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Inclusion criteria: Chronic stage of stroke (time of injury over 6 months);
Hemiparesis; unilateral brain lesion and non-recurring, mild to moderate spasticity, with level 1 or 2 of the modified Ashworth scale;
Ability to ambulate functionally, with some assistance or personal with the use of assistive devices for walking, levels 4 and 5 of the protocol Functional Ambulation Category - FAC;
Idling (slower than 0.4 m / s) or moderate (speed from 0.4 to 0.8 m / s) according to the classification of gait based on speed;
Absence of cognitive impairment, from the score of the Mini Mental State Examination (MMSE);
Absence of other neurological or orthopedic pathologies that lead to functional sequelae than those brought by stroke or disability visual and/or hearing loss that adversely affects the training of biofeedback.
Exclusion criteria: Instability in the cardiovascular condition during training;
Lack of understanding of instructions for carrying out training
Age minimum:
40Y
Age maximum:
70Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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G00-G99
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Hemiparesis, cerebral vascular accident (CVA), disorders of gait, independence to perform daily activities C10.597.404 C10.597.622.295 C10.228.140.300.775 I01.800
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Intervention(s)
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Experimental Group I: 10 subjects underwent gait training on treadmill with weight support (30%). During training, the patients received visual stimuli (visual biofeedback) data by the monitor itself in the wake of this training. This provided individuals information in real time on the width and symmetry of the step by the appearance of the screen feet symbolic stimulus as give the individual step. The foot should stay within a rectangle 20cm displayed on the screen in order to follow the visual cues and make corrections if the movement was perceived outside the standards required. Experimental Group II: 10 patients underwent gait training on treadmill with weight support (30%). During training, the patients received auditory stimuli (auditory biofeedback), performed by a digital metronome with a frequency of 115% of the average pace of the individual. Control group: 10 subjects underwent gait training on treadmill with weight support (30%), without any track, whether visual or auditory. All subjects had only one training session and were assessed before and after training the same.
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Primary Outcome(s)
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Improvement of temporal spatial and angular patterns of gait in humans after intervention assessed by kinematic analysis that seeks to acquire images from the execution of the movement, observing the behavior of dependent variables such as velocity, displacement, position and orientation body and its parts.
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Secondary Outcome(s)
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Improvement in neurological status of human subjects with hemiparesis as well as their motor skills after the intervention, through the National Institute of Health Stroke Scale (NIHSS). It is expected that individuals have lower values after training.
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Improvement of motor function of subjects with hemiparesis after the gait training, evaluation by means of protocol Stroke Rehabilitation Assessment of Movement (STREAM. It is expected that individuals have higher scores after the training.
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Secondary ID(s)
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0171. 0 051. 000-09
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Source(s) of Monetary Support
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Universidade Federal do Rio Grande do Norte - UFRN - Natal, RN, Brazil
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