Effect of mirror therapy associated with functional tasks in arm function after stroke

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-83mmq5
• Date of registration: 07/07/2011
• Primary sponsor: Universidade do Estado de Santa Catarina - Brazil
• Public title: Effect of mirror therapy associated with functional tasks in arm function after stroke
• Scientific title: Effect of mirror therapy associated with functional tasks in arm function after stroke: a randomised clinical trial
• Date of first enrolment: 01/03/2011
• Target sample size: 30
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-83mmq5/
• Study design: Prospective study, randomized clinical trial and evaluator blinded to the treatment group. The randomization will be made after the initial evaluation and stratification by level of severity according to the Fugl-Meyer scale in: mild (greater than 50 points) or moderate (between 30 and 49 points). The randomization in blocks of 4 will be obtained by a random number by the sequence being computer generated placed on opaque envelopes numbered sequentially and stapled. The process is repeated for each block of 4 and independently for each stratum. After stratification in mild or moderate, an independent researcher will give the envelope of sequence to the therapist who performs the training. Groups of treatments carried out shall be identified in papers placed inside envelopes as: experimental group – EXP-with mirror or control group – CTL-"without" mirror. Treatment with bilateral functional movements and observation in the mirror of the movements of the paretic upper limb (EXP

Countries of recruitment

Brazil

Contacts

• Name: Letícia Rodrigues
• Affiliation: Letícia Cardoso Rodrigues

• Name: Stella Michaelsen
• Affiliation: Universidade do Estado de Santa Catarina

Key inclusion & exclusion criteria

Inclusion criteria: This will include individuals who suffered Stroke proven by CT scan or MRI for at least 6 months (chronic phase). Those with motor recovery level > 30 (mild or moderate impairment) in the upper extremity section of the Fugl-Meyer motor assessment, scores on the modified Ashworth scale 2 or less for muscle groups evaluated (horizontal shoulder adductors, elbow flexors and wrist and finger flexors) and those able accomplish a task of handling rough (reach and grab a cylindrical object).
Exclusion criteria: Will be excluded individuals with other neurological diseases, orthopedic problems in the upper limbs that interfere with the function of these, significant visual impairment not correctable, aphasia or difficulty to understanding simple tasks (eg reach and grasp a bottle); visual hemineglect verified through the Bells Test; members of other research or therapy involving the upper limbs.

Age minimum: 40Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

G00-G99

Individuals with hemiparesis after stroke with mildly or moderately Motor impairment of upper limb (Fugl-Meyer Arm > 30/66).
C10.597.636
A01.378.800
E02.779.483

Intervention(s)

Participants will be divided at randomly into experimental group and control group. The mirror box used in training is made of wood, open at the top with a mirror arranged perpendicularly to the center and slightly tilted. Both groups will perform the exercise protocol three times a week for one hour, for a period of 4 weeks. Symmetrical bilateral tasks will be used, directed to an objective task and the difficulty will progress according to predetermined parameters. The tasks used in training involve daily use objects (ball, bottle, etc.) duplicated, sometimes divided at the center and placed on each side of the mirror. Will be used a systematic method of progression specific to each patient, based on the principles of "Shaping" used in the constraint induced therapy in order to control the progressions made in the tasks. This approach proposes that the tasks used in training increase the level of dificulty (such as distance and speed) in small steps according to the improvement in motor ability of the participant. The experimental group will perform the tasks mentioned and will be instructed to perform simultaneous movements with his hands, aimed at an objective, observing and focusing on the non paretic limb image in the mirror so that it causes the illusion of a bilaterally symmetrical and coordinated movement .
The control group will also perform the same tasks, trying to perform the movement as symmetrical as possible, but with the mirror covered by a sheet of paper and watching the movement of the paretic upper limb directly.

Primary Outcome(s)

Upper extremity performance test for the elderly (Tempa):The scores obtained by the observer are based on speed of execution, functional level and functional analysis of the tasks performed. The scores refers to the functional independence of each individual task, being graded according to a four-level scale (0= completes the task until 3 = can not complete the task). The analysis of tasks 0 to 3 quantifies the difficulties encountered by the subject, according to five items: strength, range of motion, precision of broad movements, grip and precision of fine movements. This instrument will be evaluated by films by an evaluator blind to the training group and the sequence of films. There will be an assessment before and after training and 2 weeks of follow-up. The bilateral and unilateral tasks of the TEMPA will be considered separately.

Secondary Outcome(s)

Fugl-Meyer Motor Assessment(upper limb section, Brazilian version): It consists of a cumulative numerical scoring system that assesses the motor function of upper extremity speed and coordination, totaling 66 points. Will be participated in this study individuals with scores between 50 and 65 that reflect mild impairment, and between 30 and 49 indicating moderate impairment. This instrument will be administered by an evaluator blind to the training group. There will be an assessment before and after training and 2 weeks at follow-up evaluation.

The Modified Ashworth Scale: consists of a scale to verify the tonus of specific muscle groups and grade spasticity. The score ranges from 0 to 4. The groups will be tested: shoulder horizontal adductors, elbow flexors, wrist flexors and fingers. This instrument will be administered by an evaluator blind to the training group. There will be an assessment before and after training and 2 weeks at follow-up evaluation.

Secondary ID(s)

111/2009

Source(s) of Monetary Support

Letícia Cardoso Rodrigues - Brazil