Neurophysiological and Kinematic Predictors of Response in Chronic Stroke
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/16/2018 |
| Start Date: | February 2016 |
| End Date: | April 2020 |
| Contact: | Susan Conroy, DSc.PT |
| Email: | susan.conroy@va.gov |
| Phone: | (410) 637-3213 |
The purpose of this study is to design a predictive model of stroke recovery based on
baseline measurements of arm movement and brain physiology. The expectation is the
development of a formula to predict a person's response to an arm rehabilitation program
provided in the chronic phase (6 months or greater post stroke) of recovery. The study will
include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), genetic
testing using saliva, and an arm exercise program consisting of robot-assisted exercise
combined with functional arm exercise called transition to task training (TTT).
baseline measurements of arm movement and brain physiology. The expectation is the
development of a formula to predict a person's response to an arm rehabilitation program
provided in the chronic phase (6 months or greater post stroke) of recovery. The study will
include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), genetic
testing using saliva, and an arm exercise program consisting of robot-assisted exercise
combined with functional arm exercise called transition to task training (TTT).
After informed consent, a baseline neurological exam, MRI of the brain, TMS, questionnaires,
cognitive testing, robot evaluations, and arm function testing will occur. Baseline testing
will occur in the first 4-6 weeks of participation including three separate sessions
approximately 1 week a part to examine arm strength, range of motion, and ability to perform
functional tasks. Additionally, one robot evaluation, one MRI and two TMS sessions will be
completed. We will also collect genetic data using a saliva sample to examine potential
genetic polymorphisms that might influence response to therapy.
The intervention phase consists of 12 weeks of robot and arm exercise training (TTT).
Interventions will occur 3 times per week for 12 weeks for a total of 36 visits. Additional
time and visits will be allowed with visits occurring 4 times per week or up to 4 additional
weeks (not to exceed 16 weeks) if scheduling conflicts arise. The intervention sessions will
be one hour in duration.
During the hour long intervention, 45 minutes of robotic intervention will be followed by 15
minutes of TTT. Two separate robots targeting different movements will be used for the 3
phases of the robot training. The training will be sequential with 12 sessions completed on
the wrist robot, followed by 12 sessions on the shoulder-elbow robot and the final 12
sessions alternating between the wrist and elbow-shoulder robot.
cognitive testing, robot evaluations, and arm function testing will occur. Baseline testing
will occur in the first 4-6 weeks of participation including three separate sessions
approximately 1 week a part to examine arm strength, range of motion, and ability to perform
functional tasks. Additionally, one robot evaluation, one MRI and two TMS sessions will be
completed. We will also collect genetic data using a saliva sample to examine potential
genetic polymorphisms that might influence response to therapy.
The intervention phase consists of 12 weeks of robot and arm exercise training (TTT).
Interventions will occur 3 times per week for 12 weeks for a total of 36 visits. Additional
time and visits will be allowed with visits occurring 4 times per week or up to 4 additional
weeks (not to exceed 16 weeks) if scheduling conflicts arise. The intervention sessions will
be one hour in duration.
During the hour long intervention, 45 minutes of robotic intervention will be followed by 15
minutes of TTT. Two separate robots targeting different movements will be used for the 3
phases of the robot training. The training will be sequential with 12 sessions completed on
the wrist robot, followed by 12 sessions on the shoulder-elbow robot and the final 12
sessions alternating between the wrist and elbow-shoulder robot.
Inclusion Criteria:
- Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other
possible diagnosis
- Stroke onset at least 6 months before enrollment
- Present with Mild/Moderate to Severe arm dysfunction (based on Fugl-Meyer scores of 10
to 45)
- Be medically stable to participate in the study and not have contractures or other
impairments that would interfere with the interventional training.
Exclusion Criteria:
- Unable to give informed consent
- Have a serious complicating medical illness that would preclude participation.
- Contractures or orthopedic problems limiting range of joint motion in the potential
study arm
- Visual loss such that the subject would not be able to see the test patterns on the
robot computer monitor
- Botulinum toxin to study arm within four months of study enrollment or if received
during the study period
- Unable to comply with requirements of the study
- Participants with a history of a seizure will not be precluded from the study, but
will not be enrolled in the TMS portions
- Participants with electromagnetic exclusions (metal implants in the cranium, implanted
electronic devices etc.) will not be precluded from the study but will be excluded
from the MRI and TMS portions
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