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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT01049802
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age
* An ischemic or hemorrhagic stroke suffered 3-9 months prior to the study
* no other known brain abnormalities by history or by structural MRI
* A one-sided stroke resulting in upper extremity paresis
* A Chedoke Arm and Hand Activity Inventory score of 3-6 for the affected limb
Exclusion Criteria:
* Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump
* Pregnant or trying to become pregnant
* History of alcohol abuse, illicit drug use or drug abuse or significant mental illness
* any history of epilepsy
* Any condition that would prevent the subject from giving voluntary informed consent
* An implanted brain stimulator
* Aneurysm clip or other metal in body
* Enrolled or plans to enroll in an interventional trial during this study
* Scalp wounds or infections
* Claustrophobia precluding MRI
* A fixed contraction deformity in the affected limb
* Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale \>2/4 in the affected limb
* previous stroke with residual deficits (TIAs not a reason for exclusion)
* premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology
* a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification \> 3), or other major medical condition
* confirmed or suspected lower-limb fracture preventing mobilization
* patients requiring palliative care
* patients undergoing any other occupational therapy than what is provided in the study
* A recent injection of botulinum toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up
* Ataxia as measured by a score \> 1 on item 7 (limb ataxia) of the NIH stroke scale
* Severe aphasia as measured by a score of \> 2 on item 9 (best language) of the NIH stroke scale
* Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01049802
Study Brief:
Protocol Section:
NCT01049802