Trial record 2 of 5 for:    "Cerebral palsy spastic diplegic"

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014