Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT01253018
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01253018
Study Brief:
Protocol Section:
NCT01253018