Status:
TERMINATED
Efficacy of Botulinum Toxin Injections in the Rectus Femoris to Treat Stiff Knee Gait Following Acquired Brain Injury
Lead Sponsor:
Mary Free Bed Rehabilitation Hospital
Collaborating Sponsors:
Allergan
Conditions:
Stiff Knee Gait
Brain Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Stiff knee gait is a common gait dysfunction following acquired brain injury. This gait deviation is characterized by reduced knee flexion during swing phase of the gait cycle and adversely impacts sa...
Detailed Description
Pathophysiologic factors that may contribute to stiff knee gait in persons with brain injury are muscle hypertonicity of the quadriceps muscles, hip flexor weakness, and over activity of the gastrocso...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00900666
Start Date
January 1 2009
End Date
December 1 2011
Last Update
June 24 2013
Active Locations (1)
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1
Mary Free Bed Rehabilitation Hospital
Grand Rapids, Michigan, United States, 49503