Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy

Columbia University

Status and phase: Completed; Phase 3

Conditions: Cerebral Palsy

Treatments: Drug: Dysport Injectable Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03469999

AAAR1322

Details and patient eligibility

About

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 diplegia cerebral palsy.

Full 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 there is an increase in energy expenditure and oxygen consumption in children with CP. Single event multi level chemoneurolysis with abobotulinumtoxinA has been found to be an effective treatment for patients with spasticity to reduce energy expenditure by increasing walking efficiency; however many of these studies have conflicting methodological approaches. Therefore this study aims to evaluate the single event multilevel chemoneurolysis with Dysport® on energy expenditure and gait in children with spastic diplegia CP.

Enrollment: 12 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Dysport Injectable Product

Experimental group

Description:

All participants will participate in baseline data collection of energy expenditure, gait analysis, and lower limb spasticity assessment. All participants will receive single event multi level chemoneurolysis with Dysport and will have repeat data collection at 4 weeks and 12 weeks post injection.

Treatment:

Drug: Dysport Injectable Product