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 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT02830893
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years at the time of enrollment
2. Stroke onset 1-4 weeks prior to study enrollment
3. Arm motor FM score of \< 30 (out of 66) at Baseline Visit
4. Absence of moderate to severe shoulder pain ( Score \<3 on the 10 point visual analog pain scale)
5. Any deficit in vision, alertness, language, attention, or other cognitive functions that interfere with playing the LARA games
Exclusion Criteria:
1. Age \>80 years at the time of enrollment
2. Severe tone in the affected upper extremities (Score ≥ 4 on the Modified Ashworth Spasticity Scale)
3. Severe language problem that would prevent participants from properly understanding instructions
4. Severe reduced level of consciousness
5. Severe aphasia (score of 3 on the NIH stroke scale (question 9))
6. Severe loss of sensation in stroke-affected upper extremities (Score \< 1 on the Nottingham sensory assessment)
7. Currently pregnant
8. Difficulty in understanding or complying with the instructions given by the experimenter
9. Inability to perform the experimental task that will be studied
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02830893
Study Brief:
Protocol Section:
NCT02830893