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

NCT00900666 | Terminated Results

• 1 other identifier: MFB2008.08
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 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

Keywords

Stiff knee gait; Gait analysis; Traumatic Brain Injury; Acquired Brain Injury

Outcome Measures

Primary Outcomes (1)

• Mean Peak Knee Flexion During Swing Phase of Gait

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

  baseline, 1-month and 4-month post-injection

Secondary Outcomes (1)

• Gait Function (Based on 6-Minute Walk)

  baseline, 1-mo and 4-mo post-injection

Study Arms (2)

Saline injection

PLACEBO COMPARATOR

Drug: placebo

Botulinum toxin injection

EXPERIMENTAL

Drug: botulinum toxin A (BTX-A)

Interventions

placebo DRUG

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.

Saline injection

botulinum toxin A (BTX-A) DRUG

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.

Botulinum toxin injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mary Free Bed Rehabilitation Hospital: lead
• Allergan: collaborator

Study Sites (1)

Mary Free Bed Rehabilitation Hospital

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (9)

• 1. Perry J. Gait Analysis: Normal and Pathological Function. 1st Ed. Thorofare, NJ: SLACK Incorporated; 1992.

  BACKGROUND

• Kerrigan DC, Gronley J, Perry J. Stiff-legged gait in spastic paresis. A study of quadriceps and hamstrings muscle activity. Am J Phys Med Rehabil. 1991 Dec;70(6):294-300.

  PMID: 1741998 BACKGROUND

• Sutherland DH, Davids JR. Common gait abnormalities of the knee in cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):139-47.

  PMID: 8458127 BACKGROUND

• Perry J. Distal rectus femoris transfer. Dev Med Child Neurol. 1987 Apr;29(2):153-8. doi: 10.1111/j.1469-8749.1987.tb02130.x.

  PMID: 3582785 BACKGROUND

• Ward AB, Molenaers G, Colosimo C, Berardelli A. Clinical value of botulinum toxin in neurological indications. Eur J Neurol. 2006 Dec;13 Suppl 4:20-6. doi: 10.1111/j.1468-1331.2006.01650.x.

  PMID: 17112346 BACKGROUND

• Cosgrove AP, Corry IS, Graham HK. Botulinum toxin in the management of the lower limb in cerebral palsy. Dev Med Child Neurol. 1994 May;36(5):386-96. doi: 10.1111/j.1469-8749.1994.tb11864.x.

  PMID: 8168657 BACKGROUND

• Chantraine F, Detrembleur C, Lejeune TM. Effect of the rectus femoris motor branch block on post-stroke stiff-legged gait. Acta Neurol Belg. 2005 Sep;105(3):171-7.

  PMID: 16255155 BACKGROUND

• Sung DH, Bang HJ. Motor branch block of the rectus femoris: its effectiveness in stiff-legged gait in spastic paresis. Arch Phys Med Rehabil. 2000 Jul;81(7):910-5. doi: 10.1053/apmr.2000.5615.

  PMID: 10896003 BACKGROUND

• Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.

  PMID: 18164331 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

Early termination due to difficulty identifying and recruiting participants.

Results Point of Contact

• Title: Krisanne B. Chapin, PhD
• Organization: Mary Free Bed Rehabilitation Hospital

krisanne.chapin@maryfreebed.com

616-493-9831

Study Officials

• Krisanne B Chapin, PhD

  Mary Free Bed Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

• Cathy Harro, PT, MS, NCS

  Grand Valley State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager and Clinical Biomechanist

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 24, 2013
• Results First Posted: June 24, 2013

Record last verified: 2013-05

Locations

US (1)