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

NCT ID: NCT00261131

Last Updated: 2009-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-12-31

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.

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.

Conditions

Spastic Diplegic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Botulinum Toxin A

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Shriners Hospitals for Children

OTHER

Sponsor Role: lead

Principal Investigators

Philip E. Gates, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children

Other Identifiers

9199

Identifier Type: -

Identifier Source: org_study_id