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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT02747433
Eligibility Criteria:
Inclusion Criteria:
* Moderate UE hemiparesis (i.e. some ability to move shoulder, elbow \& hand and initial score on the Fugl-Meyer Assessment (FMA) between 21-50/66))
* Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score \>/=26/30)12 during initial evaluation visit
Exclusion Criteria:
* No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy
* Increased muscle tone as indicated by score of \>/= 3 on the Modified Ashworth Scale;
* Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test 13
* Aphasia sufficient to limit comprehension and completion of the treatment protocol
* Currently enrolled or has plans to enroll in other upper limb therapy/research during the study period
* Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
82 Years
Study:
NCT02747433
Study Brief:
Protocol Section:
NCT02747433