Evaluation of Robot Assisted Neuro-Rehabilitation
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2011 |
| End Date: | January 2015 |
Evaluation of Robot Assisted Neuro-rehabilitation
Robotic devices are capable of providing therapy to the arm of patients with weakness due to
stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of
the weak arm for real life situations often remains limited. The goal of this study is to
determine the best way to use robotic devices and functional task training to improve the
use of the stroke affected arm for real life situations. A secondary goal of this study is
to determine how or if specific areas of the brain are excited before and after training.
The use of a safe and painless magnetic field directed at the brain called transcranial
magnetic stimulation (TMS) will be used at set intervals to gain a better understanding of
brain activity during recovery.
stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of
the weak arm for real life situations often remains limited. The goal of this study is to
determine the best way to use robotic devices and functional task training to improve the
use of the stroke affected arm for real life situations. A secondary goal of this study is
to determine how or if specific areas of the brain are excited before and after training.
The use of a safe and painless magnetic field directed at the brain called transcranial
magnetic stimulation (TMS) will be used at set intervals to gain a better understanding of
brain activity during recovery.
After obtaining informed consent, participants will undergo 3 sessions of baseline testing
using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper
extremity kinematic and strength testing will be performed with the rehabilitation robots in
measurement mode. The rehabilitation robot modules include the wrist, the planar
(shoulder-elbow), and alternating wrist and shoulder-elbow robot. These robotic devices are
cleared for marketing as a registered medical device under U.S. FDA regulations and are
listed with the FDA both as an evaluation devices and as therapy devices.
Patients will be randomized to receive 12 weeks of robotic therapy sessions or 12 weeks of
robot therapy combined with transition to task therapy. Study interventions will occur 3
times a week for 12 weeks. Robot therapy will consist of a progression through three robot
modules: wrist, planar, and alternating wrist and shoulder-elbow robot. The progression will
be sequential with four weeks of training on each robotic device. All participants will
complete a motor activity log during this intervention phase.
TMS is being used for physiological measurement and evaluations will be conducted with each
participant at baseline, week one, week five, eight, and final. TMS will also occur during
the follow-up on week twenty-four.
Disability and depression questionnaires, upper extremity measures and evaluations of
functional performance will be conducted during the study at baseline, and at training
completion (visit 36). Patients will return twelve weeks after the end of the training
period to determine whether any observed improvements persist.
using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper
extremity kinematic and strength testing will be performed with the rehabilitation robots in
measurement mode. The rehabilitation robot modules include the wrist, the planar
(shoulder-elbow), and alternating wrist and shoulder-elbow robot. These robotic devices are
cleared for marketing as a registered medical device under U.S. FDA regulations and are
listed with the FDA both as an evaluation devices and as therapy devices.
Patients will be randomized to receive 12 weeks of robotic therapy sessions or 12 weeks of
robot therapy combined with transition to task therapy. Study interventions will occur 3
times a week for 12 weeks. Robot therapy will consist of a progression through three robot
modules: wrist, planar, and alternating wrist and shoulder-elbow robot. The progression will
be sequential with four weeks of training on each robotic device. All participants will
complete a motor activity log during this intervention phase.
TMS is being used for physiological measurement and evaluations will be conducted with each
participant at baseline, week one, week five, eight, and final. TMS will also occur during
the follow-up on week twenty-four.
Disability and depression questionnaires, upper extremity measures and evaluations of
functional performance will be conducted during the study at baseline, and at training
completion (visit 36). Patients will return twelve weeks after the end of the training
period to determine whether any observed improvements persist.
Inclusion Criteria:
- Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other
possible diagnoses
- Adequate language, and cognitive function to participate in training, testing, and
informed consent process
- The study arm of the participant will present with moderate to severe dysfunction
based on Fugl-Meyer Motor Assessment range of 7 to 38
- Stroke onset greater than 6 months for ischemic stroke and greater than 1 year for
hemorrhagic stroke
- Men or women over 21 years of age
Exclusion Criteria:
- Seizures or treatment with anticonvulsant medications within the last 10 years (This
criteria does not preclude participation in the study, but does preclude
participation in the TMS testing)
- Treatment with any medications known to interfere with brain stimulation: any
medication with central nervous system depressant activity, including, but not
limited to benzodiazepines, barbiturates, and neuroleptics (This criteria does not
preclude participation in the study, but does preclude participation in the TMS
testing)
- Serious complicating medical conditions, contractures or orthopedic problems in the
study arm limiting the range of joint movement for the study positions
- Visual loss such that the participant cannot see the test patterns on the monitor of
the training robot computer
- Botox injection to the study arm within 3 months of enrollment or during the study
period
- Any change in the exercise regime involving the study arm. This includes starting any
new exercise or discontinuing any current exercise regimen
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