Status:
COMPLETED
Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy
Lead Sponsor:
Columbia University
Conditions:
Cerebral Palsy
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
This study aims to evaluate the efficacy of single event multi level chemoneurolysis with the abobotulinumtoxin A drug, Dysport®, on walking energy expenditure and gait in children with spastic dipleg...
Detailed Description
Cerebral Palsy (CP) is the leading cause of disability in children, with the most widespread type of CP being spastic CP which negatively affects physical function. Specifically it is reported that th...
Eligibility Criteria
Inclusion
- Age: 5-17 years. Must be \<18 prior to injection.
- \>10 kilograms at screening and injection visits
- Diagnosis of spastic diplegia or mild- to moderate spastic quadriplegia Cerebral Palsy
- Gross Motor Function Classification System level: I, II, III
- Ability to ambulate independently without aid, equinus gait
- Absent of joint or bone deformities
- Eligible to receive single-event multi-level chemoneurolysis (SEMLC)
- Cooperative and tolerant to testing procedures during clinic screening
- Presence of spasticity in one or both legs
- Be on a stable dose and regimen if on any prescribed medication/s
- Parent must have signed written informed consent and the Patient Authorization for Use and Release of Health and Research Study Information
Exclusion
- Ankle contractures no more than -10 degrees with the knee extended
- Hemiplegia
- Wheelchair dependent
- Received Botulinum toxin within previous 4 months
- Uncontrolled epilepsy or certain types of seizures
- Fracture in the study limb within previous 12 months
- Infection or skin disorder at planned injection site
- Shortness of breath or other respiratory issues
- Uncontrolled clinically significant medical condition
- Received phenol or alcohol block in the study limb within previous 6 months
- Surgery in the study limb within previous 12 months
- Serial casting within previous 12 months
- New physiotherapy and/or orthotic regimen \<1 month before study start. (physiotherapy and/or orthotic regimen will be permitted if it began \>1 month before study start and maintained throughout study)
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03469999
Start Date
December 12 2018
End Date
May 26 2021
Last Update
June 1 2022
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032