Robotic Training for Stroke Neurorehabilitation
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/18/2018 |
| Start Date: | May 7, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Rahsaan Holley, MS |
| Email: | rahsaan.holley@medstar.net |
| Phone: | (202) 877-1875 |
Task-Specific Upper-Extremity Robotic Training for Stroke Neurorehabilitation
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.
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.
In a pilot clinical trial, the investigators found that the current robotic exoskeleton
elicited improvements in arm function that can potentially supplement conventional methods to
improve outcomes. However, the robot has a very large inertia and friction, and only gross
grasp patterns are available. Therefore, improvements in movement speed and fine grasp were
limited after robotic training. In development work, the investigators will significantly
modify the ARMin and HandSOME to deliver a state-of-the-art lightweight robotic exoskeleton
capable of retraining a wide range of functional activities. The investigators will reduce
the inertia and friction of the robot to 1/4 of current values, incorporate an adaptive
algorithm to automatically adjust assistance levels and extend the range of grasp patterns to
include power grasp, thumb-index finger pinch and key pinch. Using the improved device from
the development activities, the investigators will perform a clinical trial to compare the
effectiveness of robotic training to conventional therapy from an occupational therapist. To
take advantage of the facilitatory effect of robot therapy on subsequent conventional
therapy, the experimental treatment will be 12 hours of robot therapy followed by 12 hours of
conventional therapy. Chronic stroke subjects (N=38) will be randomly assigned to receive
this experimental treatment or 24 hours of conventional therapy from an occupational
therapist.
elicited improvements in arm function that can potentially supplement conventional methods to
improve outcomes. However, the robot has a very large inertia and friction, and only gross
grasp patterns are available. Therefore, improvements in movement speed and fine grasp were
limited after robotic training. In development work, the investigators will significantly
modify the ARMin and HandSOME to deliver a state-of-the-art lightweight robotic exoskeleton
capable of retraining a wide range of functional activities. The investigators will reduce
the inertia and friction of the robot to 1/4 of current values, incorporate an adaptive
algorithm to automatically adjust assistance levels and extend the range of grasp patterns to
include power grasp, thumb-index finger pinch and key pinch. Using the improved device from
the development activities, the investigators will perform a clinical trial to compare the
effectiveness of robotic training to conventional therapy from an occupational therapist. To
take advantage of the facilitatory effect of robot therapy on subsequent conventional
therapy, the experimental treatment will be 12 hours of robot therapy followed by 12 hours of
conventional therapy. Chronic stroke subjects (N=38) will be randomly assigned to receive
this experimental treatment or 24 hours of conventional therapy from an occupational
therapist.
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
We found this trial at
1
site
Washington, District of Columbia 20422
Principal Investigator: Peter S. Lum, PhD
Phone: 202-745-8328
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