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

NCT00261131 | Completed Phase 3

• 1 other identifier: 9199
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spastic Diplegic Cerebral Palsy

Keywords

cerebral palsy; spasticity; diplegia

Outcome Measures

Primary Outcomes (4)

• 3DGA Kinematics

• Passive Range of Motion

• Spasticity Measurement with AShworth and Tardieu Scales

• Muscle Strength and Control

Secondary Outcomes (5)

• Gross Motor Function Measurement (GMFM)

• Pediatric Outcomes Data Collection Instrument (PODCI)

• Gillette Functional Assessment Questionnaire (GFAQ)

• 6-Minute Walk Test

• Goal Attainment Scale (GAS)

Interventions

Botulinum Toxin A DRUG

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Rhizotomy surgery within the last 1 year;
• Lower extremity surgical procedures (soft tissue or bony) within the past 1 year;
• Currently implanted and operating Intrathecal Baclofen Pump (oral baclofen OK);
• Lower extremity BTX-A injections within the past 6 months;
• Multilevel BTX-A injections;
• Gait trainer reliance;
• Serial casting 3 months prior to or during study protocol.

Sponsors & Collaborators

• Shriners Hospitals for Children: lead
• University of Virginia: collaborator
• Washington University School of Medicine: collaborator

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Philip E. Gates, MD

  Shriners Hospitals for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2005
• First Posted: December 2, 2005
• Study Start: March 1, 2006
• Study Completion: December 1, 2007
• Last Updated: February 5, 2009

Record last verified: 2009-02