Status:
COMPLETED
Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy
Lead Sponsor:
Shriners Hospitals for Children
Collaborating Sponsors:
University of Virginia
Washington University School of Medicine
Conditions:
Spastic Diplegic Cerebral Palsy
Eligibility:
All Genders
3-18 years
Phase:
PHASE3
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 ce...
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 inj...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00261131
Start Date
March 1 2006
End Date
December 1 2007
Last Update
February 5 2009
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