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Stiff Knee Gait clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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Terminated
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NCT ID: NCT00900666 Terminated - Brain Injuries Clinical Trials

Efficacy of Botulinum Toxin Injections in the Rectus Femoris to Treat Stiff Knee Gait Following Acquired Brain Injury

Start date: January 2009
Phase: N/A
Study type: Interventional

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 safe foot clearance. Stiff knee gait is an inefficient gait pattern and slows walking speed, limiting one's ability to adapt walking to community mobility demands. Fall risk is increased with this gait problem due to low or ineffective foot clearance. Common compensatory strategies are employed, such as circumduction, hip hiking or vaulting, during ambulation. The purpose of this study is to examine both the immediate (one month post-injection) and longer-term (4 months post-injection) effects of botulinum toxin injections to the rectus femoris (RF) on gait function in persons with brain injury. This study is clinically important to help inform rehabilitation professionals regarding treatment decisions for management of inefficient and often unsafe stiff knee gait problems following brain injury. Research Questions: - Is there a statistically significant difference in mean peak knee flexion between the experimental and control group? - Is there a statistically significant difference in mean peak knee velocity during the preswing and initial swing phases of gait between the experimental and control group? - Is there a statistically significant difference in gait function (based on 6-Minute Walk time and temporal distance measures) between the experimental and control group?