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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT00900666
Eligibility Criteria:
Inclusion Criteria:
* Greater than 6 months post-acquired brain injury
* Male or female subjects, at least 18 years of age
* Independent ambulation with or without assistive device or orthotic device
* Cognitive Rancho Level VI or higher, ability to follow directions, and likely to complete all required visits
* At least 100 degrees of passive knee flexion ROM
* Gait velocity greater than or equal to 0.4 m/sec
* Modified Ashworth scale rating of 1+ or higher for RF spasticity
* Written informed consent and/or assent has been obtained
* Meet criteria for stiff knee gait based on baseline computerized gait analysis data less than 2 weeks prior to receiving intervention, including:
* Peak knee flexion less than or equal to 50 degrees (or \> 2 standard deviations below normal adult peak knee flexion)
* Peak knee flexion velocity less than or equal to 256 degrees/% gait cycle (or \> 2 standard deviations below normal peak knee flexion velocity)
Exclusion Criteria:
* Change in spasticity medications during course of the study
* Ankle plantarflexion contracture greater than 0 degrees
* Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study
* Has had treatment with botulinum toxin of any serotype to RF or gastrocsoleus up to 12 months prior to enrollment in study
* Evidence of current alcohol or drug abuse or history of neuropsychiatric condition not related to ABI
* Concurrent participation in another investigational drug or device study up to12 months prior to enrollment in study
* Infection or skin disorder at an anticipated injection site
* Uncontrolled clinically significant medical condition other than the condition under evaluation
* Known allergy or sensitivity to any of the components in the study medication, including human serum albumin and sodium chloride as well as the botulinum toxin protein
* Any medical condition that may put the subject at increased risk with exposure to BOTOX including, but not limited to, diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, peripheral neuropathy or any other disorder that might interfere with neuromuscular function
* Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00900666
Study Brief:
Protocol Section:
NCT00900666