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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induced Constraint Therapy - ICT | Experimental | Physical rehabilitation with Induced Constraint Therapy as part of the occupational therapy. Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy. |
|
| Robotic occupational therapy | Experimental | Physical rehabilitation with Robotic occupational therapy. Robotic Occupational Therapy three times a week for twelve weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic occupational therapy | Procedure | Robotic Occupational Therapy three times a week for twelve weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change on Motor Function assessed by Wolf Motor Function scale | Change from baseline in Wolf Motor Function scale. | Baseline and 12 weeks |
| Change on Motor Function assessed by Fugl Meyer scale | Change from baseline in Fugl Meyer scale. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change on Motor Function assessed by Wolf Motor Function scale | Multiple changes from baseline in Wolf Motor Function scale. | Baseline, 3 months and 12 months |
| Change on Motor Function assessed by Fugl Meyer scale |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological Evaluation assessed by Perceived Stress Scale (PSS-10) | Multiple changes from baseline in PSS-10. | Baseline, 12 weeks, 3 months and 12 months |
| Neuroplasticity as assessed by Brain Derived Neurotrophic Factor (BDNF) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linamara Rizzo Battistella, Md PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Pesquisa ClÃnica do Instituto de Medicina FÃsica e Reabilitação do HCFMUSP | São Paulo | São Paulo | 04116-040 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34366819 | Derived | Terranova TT, Simis M, Santos ACA, Alfieri FM, Imamura M, Fregni F, Battistella LR. Robot-Assisted Therapy and Constraint-Induced Movement Therapy for Motor Recovery in Stroke: Results From a Randomized Clinical Trial. Front Neurorobot. 2021 Jul 21;15:684019. doi: 10.3389/fnbot.2021.684019. eCollection 2021. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Induced Constraint Therapy - ICT | Procedure | Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy. |
|
|
Multiple changes from baseline in Fugl Meyer scale.
| Baseline, 3 months and 12 months |
| Change on Motor Function assessed by Robotic scale | Multiple changes from baseline in robotic scale. | 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. | 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. | Baseline, 12 weeks, 3 months and 12 months |
| Change on Quality of life assessed by Stroke Impact Scale (SIS) | Multiple changes from baseline in SIS. | 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. | Baseline, 12 weeks, 3 months and 12 months |
Multiple changes from baseline in BDNF.
| Baseline, 12 weeks, 3 months and 12 months |
| Corticospinal excitability as assessed by transcranial magnetic stimulation (TMS) | Multiple changes from baseline in TMS. | Baseline, 12 weeks, 3 months and 12 months |
| Neurologic evaluation as assessed by electroencephalography | Multiple changes from baseline in electroencephalography. | Baseline, 12 weeks, 3 months and 12 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |