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 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT05626894
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18-85 years of age at the time of enrollment;
* Anterior circulation ischemic stroke at least 6 months and up to 5 years prior to study enrollment;
* Unilateral upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 20 and 45;
* Intact cognitive function to understand the study procedures and goal setting (MMSE score above 23 and able to follow 3 step command);
* Being familiar and comfortable with the use of a tablet or smartphone.
Exclusion Criteria:
* Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe performance of UE tasks;
* 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 ability to see feedback on the app screen (as assessed with the star cancellation test);
* Individuals with open wounds or recent fracture (less than 3 months) in the UE, fragile skin or active infection as evaluated by the study therapist;
* Individuals currently enrolled in a UE rehabilitation program (i.e., OT, research study)
* Upper-extremity orthopedic injuries or severe pain resulting in movement limitations;
* Diagnosis of other neurological disease (i.e., Parkinson's disease, multiple sclerosis, ...);
* Severe proprioceptive deficits that impair the ability to process the vibration feedback, as assessed by physical examination during screening as assessed by the study therapist;
* Not understanding spoken or written English;
* Recent (less than 3 months) Botox injection in the UE or plan to undergo injections during the study timeline;
* Contralateral motor deficits as assessed by clinical examination;
* Brainstem and cerebellar stroke.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05626894
Study Brief:
Protocol Section:
NCT05626894