Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy

This study has been completed.
Sponsor:
Collaborators:
University of Virginia
Washington University School of Medicine
Information provided by:
Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00261131
First received: November 30, 2005
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

The study proposes to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic changes not observed with normal saline injections in children with spastic diplegic cerebral palsy who walk with a flexed-knee gait pattern.


Condition Intervention Phase
Spastic Diplegic Cerebral Palsy
Drug: Botulinum Toxin A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy: A Double-Blind, Randomized, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • 3DGA Kinematics
  • Passive Range of Motion
  • Spasticity Measurement with AShworth and Tardieu Scales
  • Muscle Strength and Control

Secondary Outcome Measures:
  • Gross Motor Function Measurement (GMFM)
  • Pediatric Outcomes Data Collection Instrument (PODCI)
  • Gillette Functional Assessment Questionnaire (GFAQ)
  • 6-Minute Walk Test
  • Goal Attainment Scale (GAS)

Estimated Enrollment: 250
Study Start Date: March 2006
Study Completion Date: December 2007
Detailed Description:

This study proposes to: (1) to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic (body structure and body function) changes not observed with normal saline injections, in children with spastic diplegic CP who walk with a flexed-knee gait pattern; (2) to assess whether physiologic changes translate into functional (activity and participation) improvements; (3) to evaluate family's perception of change in function, activity, participation, and quality of life.

This study will demonstrate if BTX-A injected into overactive hamstring muscles of children with spastic cerebral palsy (CP) and a flexed-knee walking pattern has measurable effects across the spectrum of dimensions of disablement of the International Classification of Functioning, Disability, and Health (ICF). It is a multi-center, prospective, randomized, double-blind trial comparing results of injection of BTX- A and placebo saline in controls, into overactive hamstring muscles, using multiple outcomes measures. Temporal-spatial gait parameters, instrumented 3DGA kinematics, passive ROM, spasticity measurement with both Ashworth and Tardieu scales, muscle strength/control, Gross Motor Function Measurement (GMFM), Pediatric Outcomes Data Collection Instrument (PODCI), Gillette Functional Assessment Questionnaire (FAQ), 6-Minute Walk Test, and Goal Attainment Scale (GAS), assessing all ICF domains, will be collected at baseline and at 1 month, 3 months, and 6 months post-injection. Power analysis demonstrates the need to randomize 250 children (125 with BTX-A, 125 with saline), allowing for attrition. Nine participating hospitals will contribute patients.

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Spastic cerebral palsy;
  2. Bilateral lower extremity involvement;
  3. Spasticity present in the hamstrings;
  4. Flexed knee gait >15 degrees by observation (OGS);
  5. Age between 3 and 18 years old; (
  6. GMFCS Level I to Level IV; (
  7. Able to walk a minimum of 4 complete steps without resting with and without braces/shoes a minimum of 3 times;
  8. Able to follow simple commands;
  9. Cooperative with physicians and therapist;
  10. Able to tolerate application of equipment to the skin.

Exclusion Criteria:

  1. Rhizotomy surgery within the last 1 year;
  2. Lower extremity surgical procedures (soft tissue or bony) within the past 1 year;
  3. Currently implanted and operating Intrathecal Baclofen Pump (oral baclofen OK);
  4. Lower extremity BTX-A injections within the past 6 months;
  5. Multilevel BTX-A injections;
  6. Gait trainer reliance;
  7. Serial casting 3 months prior to or during study protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261131

Sponsors and Collaborators
Shriners Hospitals for Children
University of Virginia
Washington University School of Medicine
Investigators
Principal Investigator: Philip E. Gates, MD Shriners Hospitals for Children
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00261131     History of Changes
Other Study ID Numbers: 9199
Study First Received: November 30, 2005
Last Updated: February 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
cerebral palsy
spasticity
diplegia

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014