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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT03995069
Eligibility Criteria:
Inclusion Criteria:
* Survived a stroke at least 3 months ago
* Moderate to severe hand impairment (Chedoke-McMaster Hand Stage 2-4)
* Ability to generate palpable volitional grip force upon cue
* Sufficient cognitive ability to participate (NIH Stroke Scale, NIHSS, Questions and Commands score = 0-1)
* Ability to recognize all quadrants of the visual field (NIHSS Visual Field Test score = 0)
Exclusion Criteria:
* Concurrent upper limb rehabilitation
* Inability to follow 2-step commands
* Severe muscle tone prohibiting passive movement of the fingers or proper placement of the fingers on the force sensors as needed to participate in the training (Modified Ashworth Scale=4-5 out of 5)
* Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment
* Total sensory loss on fingertips (NIHSS Sensory score=2)
* Comorbidity (e.g., orthopaedic conditions that limit ranges of motion, premorbid neurologic conditions)
* Language barrier or cognitive impairment that precludes providing consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03995069
Study Brief:
Protocol Section:
NCT03995069