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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT04813120
Eligibility Criteria:
Part Ⅰ: Validation of Treatment Efficacy of the New Digital MT System with Different MVF Conditions and Training Modes
Inclusion Criteria:
* diagnosed with a unilateral stroke;
* at least 6 months after stroke onset;
* age between 20 and 80 years old;
* having a baseline score of Fugl-Meyer Assessment (FMA) in a range of 20 to 60;
* able to follow the study instructions;
* capable of participating in therapy and assessment sessions
Exclusion Criteria:
* global or receptive aphasia;
* severe neglect measured by line bisection test;
* other major medical diseases or comorbidities that have influenced upper-limb usage or caused severe pain
Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF Conditions by EEG
Inclusion Criteria:
* diagnosed with a unilateral stroke;
* at least 2 weeks after stroke onset and medical stable;
* aged 20 to 80 years;
* having a baseline score of FMA ≥ 40 and wrist flexion ≥ 20 degrees in order to perform EEG motor tasks;
* both wrist flexion and extension scores of Modified Ashworth Scale ≤ 1;
* able to follow the study instructions
Exclusion Criteria:
* global or receptive aphasia;
* severe neglect measured by line bisection test;
* other major medical diseases or comorbidities, such as neurological and psychiatric diseases, that have caused severe pain of upper-limb or interfered brain neural activities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT04813120
Study Brief:
Protocol Section:
NCT04813120