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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: Clinical Trial NA study, sponsored by Mary Free Bed Rehabilitation Hospital.

NCT00900666 is a NA study that was terminated before completion, run by Mary Free Bed Rehabilitation Hospital. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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?

Primary Outcome

Measured via computerized gait analysis, the average of peak knee flexion during swing phase.

Interventions

  • DRUG placebo
  • DRUG botulinum toxin A (BTX-A)

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2009-01
Est. Completion 2011-12
Phase NA

Why NCT00900666 stopped before completion

NCT00900666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00900666 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00900666's enrollment target sits among peer trials

19 1861st of 2000 higher than 138 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00900666, the US trial registry maintained by the National Library of Medicine. NCT00900666 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.