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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-27rmv3 |
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Date of registration:
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08/05/2012 |
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Primary sponsor: |
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Public title:
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Effect of mirror therapy in upper limb of young individuals with cerebral palsy and cerebral vascular accident
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Scientific title:
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Effects of mirror therapy in upper limbs of young individuals with hemiparesis
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Date of first enrolment:
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25/08/2011 |
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Target sample size:
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5 |
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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-27rmv3/ |
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Study type:
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Study design:
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Therapeutic, parallel, with 2 arms, single-blinded, 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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Regina
de Souza |
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Address:
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Cidade Universitaria Zeferino Vaz, s/n - Distrito de BarĂ£o Geraldo
13083-970
Campinas
Brazil |
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Telephone:
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(019) 3521-7374 |
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Email:
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reginaturolla@yahoo.com |
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Affiliation:
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UNICAMP |
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Name:
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Juliana
Lahr |
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Address:
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Rua 10A, avenidas 34 e 36, 639
13506-551
Rio Claro
Brazil |
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Telephone:
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(019) 3523-4056 |
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Email:
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ju_lahr@hotmail.com |
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Affiliation:
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Juliana Lahr |
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Key inclusion & exclusion criteria
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Inclusion criteria: Dysfunctional diagnosis of hemiparesis with brachial predominance;
Medical diagnosis of Cerebral Palsy or Cerebral Vascular Accident, of prenatal or perinatal etiology;
Age between 15 and 25 years;
Normal cognitive function.
Exclusion criteria: Visual and/or hearing impairment;
Mental deficiency;
Muscular contractions that unable the execution of the tests;
Muscle tone of affected upper limb equal to or greater than 3 in the Ashworth Scale;
Botulinum toxin injections and/or surgery during the previous 6 months;
Subjects who do not accomplished 25% or more of the intervention sessions.
Age minimum:
15Y
Age maximum:
25Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Cerebral Palsy and Cerebral Vascular Accident C10.597.636 C10.228.140.300.775
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Intervention(s)
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The intervention protocol was composed by a serie of 10 exercises, with 10 repetitions of each exercise, performed 5 times a week, for 8 consecutives weeks. The exercises were composed by flexion and extension elbow movements, pronation and supination of the forearm, to draw a circle on the table with the ulnar border of the hand, wrist circumduction with flexed elbow, flexion and extension of all fingers together, opposition of fingers in sequence, flexion and extension of fingers in sequence and cylindrical and spherical prehension. (hold a glass, hold a ball) and fine pincer grasp (hold a pencil).
Each subject performed the protocol at your home, and for this they received standardized materials like: a handbook containing the explanation of the exercises, a mirror of 70x30cm, a glass, a pencil, a ball and a diary, to write down the exercises accomplished.
The subjects were randomized into two groups of intervention. The group 1 (G1), with 3 subjects, performed the exercises with only the unaffected upper limb, unilateral training, and the group 2 (G2), with 2 subjects, performed the exercises with both upper limbs simultaneously, bilateral training. In both groups the mirror reflected the unaffected hand, and the subject can not visualize the affected hand.
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Primary Outcome(s)
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Improvement in the aspects evaluated by Fugl-Meyer Scale (motor function of the affected upper limb) and the Functional Independence Measure (functional ability in the activities of daily living), after 8 weeks of intervention with the mirror therapy.
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Secondary Outcome(s)
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Improvement the correlation between the two scales, evaluated by before and after the tratament evaluation of the Pearson correlation test.
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Secondary ID(s)
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0452.0.146.000-11
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524/2011
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Source(s) of Monetary Support
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Universidade Estadual de Campinas - UNICAMP - Campinas, SP, Brazil
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