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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT04940403
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, 18-80 years old;
2. Unilateral ischemic or hemorrhagic stroke at least 6 months and no more than 5 years prior to study enrollment;
3. Upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 12 and 40;
4. Some active pro-supination range of motion;
5. Some active metacarpal-phalangeal joint in the hemiparetic hand;
6. Intact cognitive function to understand the robotic therapy procedures (MMSE\>23 and able to follow 3 step command) during initial evaluation visit;
Exclusion Criteria:
1. Undergoing upper-limb rehabilitation therapy during the period of the study.
2. Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe use of the robotic system;
3. Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject's ability to play the interactive games (as assessed with the line bisection test);
4. Severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening;
5. Communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record);
6. Individuals with open wounds or recent fracture (\<3 months) in the upper extremity, fragile skin or active infection;
7. Upper-extremity orthopedic injuries or severe pain resulting in movement limitations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04940403
Study Brief:
Protocol Section:
NCT04940403