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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-27rmv3
Date of registration: 08/05/2012
Primary sponsor: Universidade Estadual de Campinas - UNICAMP - Campinas, SP, Brazil
Public title: Effect of mirror therapy in upper limb of young individuals with cerebral palsy and cerebral vascular accident
Scientific title: Effects of mirror therapy in upper limbs of young individuals with hemiparesis
Date of first enrolment: 25/08/2011
Target sample size: 5
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-27rmv3/
Study type: 
Study design:  Therapeutic, parallel, with 2 arms, single-blinded, randomized clinical trial.  
Countries of recruitment
Brazil
Contacts
Name: Regina  de Souza
Address:  Cidade Universitaria Zeferino Vaz, s/n - Distrito de BarĂ£o Geraldo 13083-970 Campinas Brazil
Telephone: (019) 3521-7374
Email: reginaturolla@yahoo.com
Affiliation:  UNICAMP
Name: Juliana  Lahr
Address:  Rua 10A, avenidas 34 e 36, 639 13506-551 Rio Claro Brazil
Telephone: (019) 3523-4056
Email: ju_lahr@hotmail.com
Affiliation:  Juliana Lahr
Key inclusion & exclusion criteria
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: -
Health Condition(s) or Problem(s) studied
Cerebral Palsy and Cerebral Vascular Accident
C10.597.636
C10.228.140.300.775
Intervention(s)
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.
Primary Outcome(s)
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.
Secondary Outcome(s)
Improvement the correlation between the two scales, evaluated by before and after the tratament evaluation of the Pearson correlation test.
Secondary ID(s)
0452.0.146.000-11
524/2011
Source(s) of Monetary Support
Universidade Estadual de Campinas - UNICAMP - Campinas, SP, Brazil
Secondary Sponsor(s)
Universidade Estadual de Campinas - UNICAMP - Campinas, SP, Brazil
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