Clinical trial NCT01253018: Evaluation of Robot Assisted Neuro-Rehabilitation
Official title: Evaluation of Robot Assisted Neuro-rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: stroke
robotics
upper extremity rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Massachusetts Institute of Technology
name: University of Maryland, College Park
First posted: 2010-12-03
Enrollment: 59
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Motor Upper Extremity Assessment
timeFrame: Baseline, 12 week, and 24 week retention
Secondary outcomes:
measure: Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS)
timeFrame: week 12
measure: Wolf Motor Function Test (WMFT)
timeFrame: Baseline, 12 week, and 24 week retention
measure: Stroke Impact Scale: Hand Subscale
timeFrame: Baseline, 12 week and 24 week retention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Christopher T. Bever, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conroy SS, Wittenberg GF, Krebs HI, Zhan M, Bever CT, Whitall J. Robot-Assisted Arm Training in Chronic Stroke: Addition of Transition-to-Task Practice. Neurorehabil Neural Repair. 2019 Sep;33(9):751-761. doi: 10.1177/1545968319862558. Epub 2019 Jul 22.