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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT04309266
Eligibility Criteria:
Inclusion Criteria:
* Child must be between 7 and 17 years of age at the start of the study.
* Child must have hemiparesis with at least partial active grasp and release.
* Child must be able to follow multi-step commands.
* Child must have a caregiver available who can assist with implementation of home exercise program.
* Child must speak English.
* Child must have hemiparesis caused by cerebral vascular accident.
* Child must have adequate insurance to cover evaluation, re-evaluations, and intervention, as this study will be billed to participants' insurance.
Exclusion Criteria:
* Child must not have received botulinum toxin or phenol injections within 4 months of and/or during intervention.
* Child must have tone less than 3/4 on Modified Ashworth Scale.
* Child must not be considered legally blind.
* Child must not have contraindications for use of robot assisted device (ie. recent fracture or skin lesion).
* Child must not be non-verbal.
* Child must have not had reconstructive surgery to the affected upper extremity within the last year.
* Child must not be receiving active oncology plan of care.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT04309266
Study Brief:
Protocol Section:
NCT04309266