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

NCT00900666 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2013-06-24

Study results available
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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?

Conditions

  • Stiff Knee Gait
  • Brain Injuries

Interventions

DRUG

placebo

A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.

DRUG

botulinum toxin A (BTX-A)

200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Mary Free Bed Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Krisanne B Chapin, PhD · Mary Free Bed Rehabilitation Hospital

  • Cathy Harro, PT, MS, NCS · Grand Valley State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-06-30
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00900666 on ClinicalTrials.gov