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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.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-6w9nfq
Date of registration: 11/05/2012
Primary sponsor: Universidade Federal do Rio Grande do Norte - UFRN - Natal, RN, Brazil
Public title: Effects of the combination of visual or auditory cues to treadmill gait training of individuals who have suffered stroke
Scientific title: Influence of biofeedback in gait training on a treadmill with partial body weight support in hemiparetic subjects
Date of first enrolment: 01/07/2011
Target sample size: 30
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-6w9nfq/
Study type: 
Study design:  Therapeutic, parallel, single-blinded, with 3 arms, randomized clinical trial  
Countries of recruitment
Brazil
Contacts
Name: Gabriela  Gama
Address:  AV. SENADOR SALGADO FILHO, 3000- Cidade universitária- departamento de fisioterapia 59072-970 Natal Brazil
Telephone: (83) 88298003
Email: gabilopes_@hotmail.com
Affiliation:  Universidade Federal do Rio Grande do Norte - UFRN
Name: Gabriela  Gama
Address:  AV. SENADOR SALGADO FILHO, 3000- Cidade universitária- departamento de fisioterapia 59072-970 Natal Brazil
Telephone: (83) 88298003
Email: gabilopes_@hotmail.com
Affiliation:  Universidade Federal do Rio Grande do Norte - UFRN
Key inclusion & exclusion criteria
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: -
Health Condition(s) or Problem(s) studied
G00-G99
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
Intervention(s)
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.
Primary Outcome(s)
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.
Secondary Outcome(s)
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.
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.
Secondary ID(s)
0171. 0 051. 000-09
Source(s) of Monetary Support
Universidade Federal do Rio Grande do Norte - UFRN - Natal, RN, Brazil
Secondary Sponsor(s)
Universidade Federal do Rio Grande do Norte - UFRN - Natal, RN, Brazil
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