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NCT00900666 · ClinicalTrials.gov registry record · NA
Efficacy of Botulinum Toxin Injections in the Rectus Femoris to Treat Stiff Knee Gait Following Acquired Brain Injury
A NA study, sponsored by Mary Free Bed Rehabilitation Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT00900666 is a NA study that was terminated before completion, run by Mary Free Bed Rehabilitation Hospital. The registered enrollment target is 19 participants.
The verdict
NCT00900666, a NA study, was terminated before completion, sponsored by Mary Free Bed Rehabilitation Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study 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 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?
Interventions
- DRUG placebo
- DRUG botulinum toxin A (BTX-A)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2009-01 |
| Est. Completion | 2011-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00900666
The ClinicalTrials.gov registry entry for NCT00900666 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mary Free Bed Rehabilitation Hospital, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00900666 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00900666 about?
NCT00900666 is a clinical study titled "Efficacy of Botulinum Toxin Injections in the Rectus Femoris to Treat Stiff Knee Gait Following Acquired Brain Injury". 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 ...
What is the current status of trial NCT00900666?
This trial is currently terminated. It is a NA study. The enrollment target is 19 participants. The study started on 2009-01. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00900666?
The interventions under investigation include: placebo (DRUG), botulinum toxin A (BTX-A) (DRUG).
Who is sponsoring clinical trial NCT00900666?
This trial is sponsored by Mary Free Bed Rehabilitation Hospital, which has 2 total clinical trials registered on ClinicalTrials.gov.
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