Bilateral arms function after bilateral training in individuals with severe hemiparesis: a randomised clinical trial

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-5ypjzb
• Date of registration: 31/07/2011
• Primary sponsor: Universidade do Estado de Santa Catarina - Brazil
• Public title: Bilateral arms function after bilateral training in individuals with severe hemiparesis: a randomised clinical trial
• Scientific title: Bilateral upper limbs function after bilateral training in individuals with severe hemiparesis: a randomised clinical trial
• Date of first enrolment: 01/03/2011
• Target sample size: 20
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-5ypjzb/
• Study design: Clinical trial, randomized controlled trial, treatment, single blinded trial, number of arms 2.

Countries of recruitment

Brazil

Contacts

• Name: Nayara Farias
• Affiliation: Universidade do Estado de Santa Catarina

• Name: Nayara Farias
• Affiliation: Universidade do Estado de Santa Catarina

Key inclusion & exclusion criteria

Inclusion criteria: Chronic Hemiparesis (at least six months after stroke); Age over 21 years;
Severe impairment in upper limb (Fugl-Meyer in the less 30/66); Understanding simple order

Exclusion criteria: Patients with other associated neurological diagnosis; Subjects with orthopedic injuries in the upper bounds.


Age minimum: 21Y
Age maximum: 80
Gender: -

Health Condition(s) or Problem(s) studied

G00-G99

Paresis, Bilateral upper limbs function
C10.597.636

Intervention(s)

Experimental group - Individuals will be trained using a protocol of bilateral functional tasks, including symmetrical and asymmetrical bilateral activities, where most of the tasks are asymmetrical and paretic upper limb provides support for implementing the activity. A systematic progression for each task will be made. The interventions included two weeks, 10 sessions of 60 minutes each.
Control group - The control group will receive the same intensity in the experimental group, 10 sessions of 60 minutes each for two weeks of conventional physiotherapy. The effect will be assessed by evaluating the function of bilateral upper limbs

Primary Outcome(s)

Function Test Bilateral upper limbs (TEBIM):
TEBIM is a special instrument to sequela due to Cerebrovascular accident (CVA). It is to assess the interaction between MS and MS paretic and non paretic used simultaneously while performing functional activities. In carrying out the tasks proposed actions are similar day-to-day, using standard materials (Michaelsen et al., 2007).
The price of the tasks are graduate from 0 to 5. Featuring 0 to not try or can not perform the task bilaterally as an affected upper limb participated in 25% or less of the task, 2 for the affected upper limb participated in 50% of the task or less, 3 for the affected upper limb participating 75% or less of the task, four runs as the tasks fully with both arms simultaneously but with compensation for the performance and five bilateral normal.
The timing of the tasks is to assist in the functional evaluation. It stipulated a maximum time of 120 seconds to perform each task. The functional evaluation refers to the use of simultaneous bilateral upper limbs (Michaelsen et al., 2007).

Secondary Outcome(s)

CAHAI (Chedoke Arm and Hand Activity Inventory):

CAHAI consists of an instrument to evaluate bilateral motor activities in subjects with upper limb post stroke sequelae, including 13 functional tasks. Its score ranges from 1 to 7. To quote the guy needs a total assistance to perform the activity (upper limb weak <25%), score 2 corresponds to maximum assistance (upper limb weakness = 25% - 49%), 3 as moderate assistance (50 upper limb weakness = % - 74%), 4 Assistance for minimum (upper limb weakness> 75%), score 5 corresponds to only supervision during the activity, to 6 Modified independence (accessory aid) and 7 for complete independence (ordinate with seguran?a).
For all activities the score varies with the participation of the paretic MS, and the final quality of the task execution time (BARECA et al. 2005).

Fugl-Meyer Scale:

The scale is used to describe the motor recovery after stroke. In this study we will use the Fugl-Meyer Scale (FMS) for upper limbs. All items are rated on a scale of three choices: (0) without the function (2) Full function. The motor section of the FSM is arranged hierarchically and assesses aspects of motion, reflexes, coordination and speed and can total 66 points. The Brazilian-based application manual presents an interrater reliability of examiners 0.98 (Michaelsen et al. 2011). The intrarater reliability of the Brazilian version is 0.98 (MAKI et al. 2006).

Motor Activity Log (MAL):

The MAL is a structured interview that aims to examine how much and how individuals use their upper limb outside of therapeutic environment. Participants are asked by means of standard questions about the amount of use of their paretic arm (Quantity Range of Motion, or EQT) and the quality of their movements (Quality of Movement Scale or EQL) during functional activities indicated. The scales are printed on separate forms that are placed in front of the patient during the test administration. As far as the EQT EQL are scored from 0 to 5 points. The examiner should tell subjects that they can indicate 0.5 (eg 0.5, 1.5, 2.5 ...) in the scores to better reflect this reality (USWATTE et al., 2006)

Secondary ID(s)

250/2009

Source(s) of Monetary Support

Coordenação de Aperfeiçoamento de Pessoal de Nivel Superior (CAPES) - Brazil

Secondary Sponsor(s)

Nayara Correa Farias - Brazil

Universidade do Estado de Santa Catarina - Brazil