NCT02700061

Effects of Upper Limb Motor and Robotic Training Over Neuroplasticity and Function Capacity

Effects of Upper Limb Motor Training and Upper Limb Robotic Training Over Neuroplasticity and Function Capacity: A Single-blind Randomized Clinical Trial With Patients With Stroke Sequelae

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Stroke

Interventions

Type	Name	Description
PROCEDURE	Robotic occupational therapy	Robotic Occupational Therapy three times a week for twelve weeks.
PROCEDURE	Induced Constraint Therapy - ICT	Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-04-01
• Completion: 2017-02-01
• First posted: 2016-03-07
• Last updated: 2016-03-07

Locations

1 site across 1 country: Brazil