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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shriners Hospitals for Children
• Collaborators: University of Virginia; Washington University School of Medicine
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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.