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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-6qs4tb |
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Date of registration:
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09/11/2011 |
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Primary sponsor: |
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Public title:
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Effects of treadmill training with partial body weight support and the one physical therapy method on gait of patients with stroke
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Scientific title:
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Analysis of the effectiveness of treadmill training with partial body weight support and the Proprioceptive Neuromuscular Facilitation method on the hemiparetic gait due to stroke |
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Date of first enrolment:
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10/01/2010 |
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Target sample size:
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23 |
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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-6qs4tb/ |
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Study type:
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Study design:
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Clinical trial, with two arms, non-randomized, open.
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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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Ana
Lindquist |
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Address:
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Av. Senador Salgado Filho, 3000. Caixa postal: 1524
59072-970
Natal
Brazil |
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Telephone:
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+55 (84) 3342-2010 |
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Email:
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raquellindquist@ufrnet.br |
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Affiliation:
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Universidade Federal do Rio Grande do Norte |
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Name:
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Ana
Lindquist |
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Address:
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Av. Senador Salgado Filho, 3000. Caixa postal: 1524
59072-970
Natal
Brazil |
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Telephone:
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+55 (84) 3342-2010 |
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Email:
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raquellindquist@ufrnet.br |
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Affiliation:
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Universidade Federal do Rio Grande do Norte |
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Key inclusion & exclusion criteria
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Inclusion criteria: The sample was composed of men and women, aged between 40 and 70 years, with chronic hemiparesis following unilateral and non-recurring stroke, with spasticity classified between levels 0 and 2 on the Modified Ashworth Scale of muscle spasticity for the lower limb affected; ambulatory capacity classified between levels 3 and 5 on the Functional Ambulatory Category; minimum sequel time of 6 months; absence of clinical signs of cardiac alterations (New York Heart Association, degree I); absence of other orthopedic or neurological impairment that caused gait alterations; ability to walk 10m without assistive devices; not using orthotics on the paretic lower limb; and capacity to obey simple verbal commands.
Exclusion criteria: Exclusion criteria were individuals whose heart rate exceeded 75% of age-adjusted maximum heart rate and those who had fear of falling while walking on the treadmill.
Age minimum:
40Y
Age maximum:
70Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Stroke C10.597.404
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Intervention(s)
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Two experimental groups underwent gait training based on Proprioceptive Neuromuscular Facilitation method (PNF group, n=11) or using the Treadmill with Partial Body Weight Support - Gait Trainer System 2, Biodex, USA – (TPBWS group, n=12), for three weekly sessions, during four weeks. The PNF group was stimulated using basic PNF procedures and facilitation patterns, being focused manual contact, stretch and maximum resistance during preparatory activities for gait and gait activities themselves. The activities were: waist dissociation in lateral decubitus, sitting and rising from a chair training, transfer of body weight in both the anteroposterior and latero-lateral direction, frontal and lateral gait. In the TPBWS group, we used the Gait Trainer (Gait Trainer System 2 - Biodex Medical Systems, NY), a system composed of a vest attached to a suspension mechanism of body weight (Unweighing System) coupled to a treadmill. The subjects began training with a suspension of 30% in body weight and with comfortable speed; in consecutive sessions, the weight support was reduced and the speed was increased, according to feedback from the patient and the therapist's assessment.
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Primary Outcome(s)
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Kinematic analysis of gait with the Qualisys system (Qualisys Medical AB, Gothenburg, Sweden) allowed the acquisition of the following angular and spatio-temporal variables: speed (m/s), stride length (m), double-support time (s), inter-limb symmetry ratio - swing time of the paretic leg (s) / swing time of the non-paretic leg (s) -, maximum hip stance extension (°), maximum hip swing flexion (°), maximum knee swing flexion (°), ankle plantarflexion during push-off (°) and maximum ankle dorsiflexion over the swing phase (°).
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Secondary Outcome(s)
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The protocol Stroke Rehabilitation Assessment of Movement (STREAM) was used to quantify motor recovery and motor domain of the Functional Independence Measure (motor FIM) was used to assess functionality.
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Source(s) of Monetary Support
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Universidade Federal do Rio Grande do Norte - Brazil
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CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brazil
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