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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT02074150
Eligibility Criteria:
Inclusion Criteria:
* Adults with history of stroke that resulted in a unilateral, upper-limb focal spasticity
* Wrist flexor tone of more than 2 and finger flexor tone of more than 2 as measured by the Ashworth Scale
* Ability to understand and follow verbal directions
* At least 1 functional disability item (hygiene, dressing, pain, or limb posture) with a rating of more than 2 on the Disability Assessment Scale (DAS)
* At least 1 functional task score at Day 0 that met the following criteria: nail filing less than 6, hand cleaning less than 6, holding a water bottle less than 4, brushing teeth less than 4, holding fruit (small, medium, or large equals no.
Exclusion Criteria:
* Stroke within 6 months of the study enrollment visit
* Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception
* Previous or current Botox therapy of any type in the study limb
* Any medical condition that may put the patient at increased risk with Botox exposure or any other disorder that might have interfered with neuromuscular function
* Presence of fixed contracture of the study limb
* Limited use of the wrist and fingers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02074150
Study Brief:
Protocol Section:
NCT02074150