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:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT02292251
Eligibility Criteria:
Inclusion Criteria:
1. Age over 21 years
2. Ischemic stroke confirmed by CT or MRI within the previous 6 weeks
3. No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed)
4. Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment.
5. Ability to give informed consent and understand the tasks involved.
Exclusion Criteria:
1. Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.
2. Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.
3. Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.
4. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
5. History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).
6. Inability to sit in a chair and perform upper limb exercises for one hour at a time.
7. Participation in another upper extremity rehabilitative therapy study during the study period.
8. Terminal illness
9. Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02292251
Study Brief:
Protocol Section:
NCT02292251