Status:
COMPLETED
Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
Lead Sponsor:
University of Delaware
Collaborating Sponsors:
Alfred I. duPont Hospital for Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Cerebral Palsy
Muscle Spasticity
Eligibility:
All Genders
2-12 years
Phase:
NA
Brief Summary
Cerebral palsy (CP) is a neuromuscular disorder that affects approximately 800,000 individuals in the U.S. An estimated 70-80% of these individuals have spasticity which affects ambulation and require...
Detailed Description
The investigators have been working with children diagnosed with cerebral palsy (CP) for the past 10 years. The investigators have found that bone structure is markedly underdeveloped and bone strengt...
Eligibility Criteria
Inclusion
- Inclusion (Children with CP):
- Have spastic CP
- Between 2-12 years of age
- Recommended for Botox treatment by their physician as part of their clinical care. Those who accept Botox treatment and those who do not accept Botox treatment are both eligible for the study.
- A score of 1-4 on the gross motor function classification scale (GMFCS)
- Exclusion (Children with CP):
- Botox treatment in the lower extremities within the last year
- Metal rods in both legs
- Inclusion (Typically developing children):
- Between 2 and 12 years of age.
- Match a child with CP for sex, age and race.
- Exclusion(Typically developing children):
- Neurological disorder
- Surgery in the lower extremities within the last year.
- Chronic medication use
Exclusion
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01803464
Start Date
March 1 2012
End Date
February 1 2015
Last Update
March 20 2018
Active Locations (2)
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1
University of Delaware
Newark, Delaware, United States, 19716
2
Alfred I. duPont Hospital for Children, Nemours
Wilmington, Delaware, United States, 19899