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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT01329705
Eligibility Criteria:
Inclusion Criteria:
* Patients enrolled will be male or female, be at least 18 years of age, and have been diagnosed with spastic hemiplegia and excessive plantarflexion, which includes the following:
1. Diagnosis of a stroke or traumatic brain injury more than 6 months prior to enrollment in this study
2. Reduced AROM and PROM in ankle dorsiflexion
3. Ability to ambulate safely 20 feet without an ankle-foot orthosis (AFO)
4. Inability to ambulate with initial heel-contact
5. No prior BTX treatment within 6 months
6. R1 of -10° or greater (using the Tardeiu method of assessment)
7. Mean Ashworth Scale Test ≥3 for plantarflexors
Exclusion Criteria:
1. Bell's Palsy
2. Viral Encephalitis
3. Muscular Dystrophy
4. Multiple Sclerosis
5. Prior heel-cord lengthening or tendon-transfer procedure in the foot/ankle
6. Subjects with a fixed contracture of the ankle
7. Female subjects who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or are of childbearing potential and do not practice a reliable method of birth control
8. Bleeding disorders
9. Diagnosis of a disease that may interfere with neuromuscular function (ie. Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome, amyotrophic lateral sclerosis)
10. Subjects currently using aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function
11. Subjects with profound weakness or atrophy of the muscles in the target areas of injection
12. Active systemic infection or infection at the injection site
13. Allergy or sensitivity to botulinum toxin A
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01329705
Study Brief:
Protocol Section:
NCT01329705