Evaluation of Robot Assisted Neuro-Rehabilitation

Completed · Phase 1/Phase 2

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT01253018

Run by

VA Office of Research and Development

People needed

59

Starts

2011-04-27

Expected to finish

2015-01-30

Last updated by the study team

2019-10-30

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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