The purpose of this study is to evaluate and compare the effects of upper limb training with Induced Constraint Therapy (ICT) or robotic therapy. No placebo therapy is used. Motor function, neurological evaluations and quality of life are assessed for the comparison of the therapies.
The trial is being carried out in the Institute of Physical Medicine and Rehabilitation of the University of São Paulo since February 2012. The investigators are including patients with clinical diagnosis of Ischemic or hemorrhagic stroke. The patients are being randomized in blocks of four, six and eight, in two arms: ICT: patients are undergoing 60 minutes physiotherapy and occupational therapy twice a week for ten consecutive weeks. Other therapeutic services as phonoaudiology, psychology, nutrition, physical conditioning are prescribed upon the patients' medical demands. After the 10 weeks, the patients are undergoing two whole weeks of daily ICT as to reach 90% of the time under constraint, including weekends. During this last period, no other therapeutic service is offered, but the occupational therapy under ICT. Patients are not allowed to undergo robotic therapy. Robotic therapy: patients are undergoing robotic occupational therapy for 60 minutes, three times a week for twelve consecutive weeks. All other therapeutic services are prescribed upon the patients' medical demands. Patients are not allowed to undergo ICT. The investigator and the raters are blind to treatment. The evaluations are done prior to the beginning of the treatment and at the end of it. The follow up assessments are done at 3 and 12 months after the end of the treatment. The sample size was estimated to be 62 patients in each arm, a total size of 124 patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
51
Robotic Occupational Therapy three times a week for twelve weeks.
Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.
Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
São Paulo, São Paulo, Brazil
Change on Motor Function assessed by Wolf Motor Function scale
Change from baseline in Wolf Motor Function scale.
Time frame: Baseline and 12 weeks
Change on Motor Function assessed by Fugl Meyer scale
Change from baseline in Fugl Meyer scale.
Time frame: Baseline and 12 weeks
Change on Motor Function assessed by Wolf Motor Function scale
Multiple changes from baseline in Wolf Motor Function scale.
Time frame: Baseline, 3 months and 12 months
Change on Motor Function assessed by Fugl Meyer scale
Multiple changes from baseline in Fugl Meyer scale.
Time frame: Baseline, 3 months and 12 months
Change on Motor Function assessed by Robotic scale
Multiple changes from baseline in robotic scale.
Time frame: Baseline, 3 months and 12 months
Change on Function ability and quality of movement assessed by Arm Motor Ability Test (AMAT)
Multiple changes from baseline in AMAT scale.
Time frame: Baseline, 12 weeks, 3 months and 12 months
Change on Functional Independence Measure (FIM) as assessed by FIM scale
Multiple changes from baseline in FIM scale.
Time frame: Baseline, 12 weeks, 3 months and 12 months
Change on Quality of life assessed by Stroke Impact Scale (SIS)
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Multiple changes from baseline in SIS.
Time frame: Baseline, 12 weeks, 3 months and 12 months
Change on Kinematic variables assessed by InMotion robots
Multiple motion changes from baseline in the Kinematic variables assessed by InMotion robots.
Time frame: Baseline, 12 weeks, 3 months and 12 months