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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-5v3kg9
Date of registration: 08/03/2012
Primary sponsor: Universidade Nove de Julho - Brazil
Public title: Treadmill gait training for children with cerebral palsy
Scientific title: Treadmill training without body weight support on children with cerebral palsy
Date of first enrolment: 01/07/2011
Target sample size: 38
Recruitment status: recruiting
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-5v3kg9/
Study type: 
Study design:  Therapeutic, parallel, two arms, single-blind, randomized clinical trial  
Countries of recruitment
Brazil
Contacts
Name: Claudia   Oliveira
Address:  . Itapicuru 380 05006-000 São Paulo Brazil
Telephone: 11 3868 1681
Email: csantos@uninove.br
Affiliation:  Universidade Nove de Julho
Name: Luanda   Grecco
Address:  Avenida Eulina, 217 02755-140 São Paulo Brazil
Telephone: 11 3936-3756
Email: luandacollange@hotmail.com
Affiliation:  Universidade Nove de Julho
Key inclusion & exclusion criteria
Inclusion criteria: Children with cerebral palsy
Age between three and 12 years
Absence of cognitive or visual impairment that could compromise the performance of the tasks
Levels I, II and III of the Gross Motor Functional Classification System (GMFCS)
Functional ambulation for at least 12 months

Exclusion criteria: Orthopedic surgical procedures or neuromuscular block in the 12 months prior to the training sessions
Presence of orthopedic deformities with surgical indications


Age minimum: 3
Age maximum: 12Y
Gender: -
Health Condition(s) or Problem(s) studied
Cerebral palsy, Gait Disorders, Neurologic
C10.228.140.140.254
C10.597.404
G00-G99
Intervention(s)
19 children in the experimental group will undergo the gait training on a treadmill using two weekly sessions for a period of seven consecutive weeks. The first two sessions will be considered for recognition of the mat and the training will be conducted with a high speed gradually according to the tolerance of the child. Used for training will be 60-80% of the maximum speed reached during the exercise test. The child will use their usual brace, properly placed by the physiotherapist. 19 control children will undergo the gait training ground. The child uses its own bracing and when necessary to use auxiliary normal gait. Preliminary assessment will be conducted in order to verify that the auxiliary gear is appropriately sized for children. If not, it will be regulated. The first two sessions will be free to recognize the environment, and self-selected speed for the child, as well as the duration of training. In the six weeks training will last 30 minutes. In the beginning and end five minutes the child will be asked to walk at a speed comfortable and autoselecionada. In the middle 20 minutes the child will be encouraged to increase speed. You can not monitor the speed of training of this group. The heart rate will be monitored to ensure no overload on the cardiovascular system. All participants will be asked to maintain their daily activities and therapy sessions.
Primary Outcome(s)
Improvement in functional mobility and fitness evaluated by testing six-minute walk.
Secondary Outcome(s)
Improved functional balance assessed by Berg balance scale.
Improvement in cardiorespiratory fitness assessed by treadmill test.
Improvement in functional performance measured by thePediatric Evaluation of Disability Inventory.
Improvement in static balance measured by stabilometry.
Improves respiratory muscle strength assessed by evaluating the maximal inspiratory pressure and maximum expiratory pressure.
Secondary ID(s)
409972\2011
Source(s) of Monetary Support
Fundação de Amparo à Pesquisa do Estado de São Paulo - São Paulo, SP, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brasilia, DF, Brazil
Secondary Sponsor(s)
Centro de Neurocirurgia Pediátrica - São Paulo, SP, Brazil
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