Robotic Training for Stroke Neurorehabilitation
Condition: Stroke
MeSH terms: Stroke
Intervention: Robotic Therapy; Conventional Therapy
Intervention description: Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects.; An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Robotics; upper extremity; neurorehabilitation; movement therapy

Summary:

      The overall goal is to further develop a robotic exoskeleton for neurorehabilitation of arm
      function after stroke. The investigators previously developed a novel training protocol that
      combined the ARMin and HandSOME exoskeletons. This is one of only a few arm exoskeletons that
      allow coordinated whole limb training in reach and grasp tasks with both virtual and real
      objects. However, the robot has a very large inertia and friction, and only gross grasp
      patterns are available. In development work, the investigators will significantly modify the
      AMRin and HandSOME to deliver a state-of-the-art lightweight robotic exoskeleton capable of
      retraining a wide range of functional activities. In the subsequent testing phase, a clinical
      trial will examine the effects of robotic training in chronic stroke subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21 or older

          -  Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) that occurred more
             than 6 months before entering the study

          -  Presence of voluntary hand activity indicated by a score of at least 1 on the finger
             mass extension/grasp release item of the Fugl-Meyer Test of Motor Function

          -  Adequate cognitive status, as determined by clinical evaluation

          -  No upper extremity injury or conditions that limited use prior to the stroke

        Exclusion Criteria:

          -  Cannot give informed consent

          -  Have clinically significant fluctuations in mental status within a month of enrollment

          -  Were not independent prior to the stroke as measured by scores <95 on the Barthel
             Index or >1 on the Modified Rankin Scale

          -  Have hemispatial neglect as determined by >3 errors on the Star Cancellation Test

          -  Have severe sensory loss as determined by a score of 2 on the sensory item of the
             NIHSS

          -  Receiving oral or injected antispasticity medications during study treatment

          -  Pain that interferes with daily activities

          -  History of prior stroke