Robotic Training for Stroke Neurorehabilitation

Stopped early · Phase 2

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT02639390

Run by

VA Office of Research and Development

People needed

5

Starts

2018-05-07

Expected to finish

2019-12-31

Last updated by the study team

2021-01-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington DC VA Medical Center, Washington, DC — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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