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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT02459951
Eligibility Criteria:
Inclusion Criteria:
* patients who are clinically appropriate for treatment of upper limb spasticity due to stroke with Botox A injections ;
* adults up to age 80, women must be post-menopausal or are medically unable to conceive (as determined from their medical records), men must be at least age 35
* documented anemic or hemorrhagic unilateral (right or left) hemiplegic stroke, with 1 year or more prior to enrollment
* able to understand verbal and visual instructions and demonstrations regarding the protocol
* a resting wrist angle equal to or less than 0
* spasticity is present in finger flexors and thumb coupled with marked voluntary paresis of finger extension (no finger has more than half range of active extension at any joint). By squeezing the examiner's finger, participants will have demonstrated, at least, some detectable voluntary contraction of finger flexors; impaired sensation is acceptable but participants must be aware that they are holding something, as tested clinically;
* at least two finger flexors with an Ashworth score = 3;
* moderate motor severity as defined by an upper limb Fugl-Meyer motor scores between 21-50
* normal joint capsule without contractures as determined by clinical exam; participant may have tightness/shortening of extrinsic finger flexors but composite extension of wrist and fingers comes to at least neutral (i.e. fingers and wrist can be brought to neutral position simultaneously).
Exclusion Criteria:
* profound sensory loss/absent touch sensation
* known hypersensitivity/allergy to Botox A
* acute illness or unresolved medical/psychiatric conditions at time of assessment
* symptomatic lung disease and compromised respiratory status; muscle-weakening neurological disorders known to increase drug-related risk \[e.g. amyotrophic lateral sclerosis (ALS), myasthenia gravis, Lambert-Eaton syndrome, or motor neuropathy\]
* infection in the area where the study drug should be injected
* pregnancy or breast-feeding;
* participant had Botox injections less than 4 months previously
* clenched fist associated with tenodesis of an extended wrist i.e. resting position of wrist is \> 0 degrees
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT02459951
Study Brief:
Protocol Section:
NCT02459951