Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03634397 |
Other study ID # |
STUDY00008385 |
Secondary ID |
R01HD059783-06A1 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 2, 2019 |
Est. completion date |
December 29, 2023 |
Study information
Verified date |
April 2024 |
Source |
Milton S. Hershey Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study will test the hypothesis that the combination of low-moderate to severe motor
deficits in the paretic arm and persistent motor deficits in the less-impaired arm limits
functional independence in chronic stroke survivors. We, therefore, predict that intense
remediation, focused on improving the speed, coordination, and accuracy of the less-impaired
arm should improve functional independence.
Description:
We previously characterized hemisphere-specific motor control deficits in the non-paretic arm
of unilaterally lesioned stroke survivors. Our preliminary data indicate these deficits are
substantial and functionally limiting in patients with severe paresis. We have specifically
designed an intervention to remediate the hemisphere-specific deficits in the less-impaired
arm, using a virtual-reality platform, and then follow this training with manipulation
training of a variety of real objects, designed to facilitate generalization and transfer to
functional behaviors encountered in the natural environment. We propose a 2-site, two-group
randomized intervention with a treatment group, which will receive unilateral training of the
less-impaired arm, through our Virtual Reality and Manipulation Training (VRMT) protocol.
This intervention protocol is grounded in the premise that targeted remediation of
fundamental control deficits exhibited by the less-impaired arm will generalize and transfer
beyond practiced tasks to performance of activities of daily living (ADL). This approach
contrasts with the more pragmatic approach of task-specific training of essential ADL's,
which is limited in scope, more cumbersome, and ignores known fundamental motor control
deficits. Our control group will receive conventional intervention, guided by recently
released practice guidelines for upper limb intervention in adult stroke. The impact of the
proposed research is that we address persistent functional performance deficits in chronic
stroke patients with severe paresis, who's less-impaired arm impairments are generally
ignored in most current rehabilitation protocols. Our first aim addresses the overall
effectiveness of this intervention, relative to our control group: To determine whether
non-paretic arm VRMT in chronic stroke survivors with severe paresis will produce durable
improvements in less-impaired arm motor performance that will generalize to improve
functional activities and functional independence to a greater extent than conventional
therapy focused on the paretic arm. Our second aim focuses on the mechanistic basis of
potential training-related improvements in motor performance: To determine whether
intervention-induced improvements in less-impaired arm performance are associated with
improvements in hemisphere-specific reaching kinematics. Finally, our third aim monitors for
potential negative effects of our experimental intervention on paretic arm impairment.