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

NCT ID: NCT03469999

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-12
• Study Completion Date: 2021-05-26

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 diplegia cerebral palsy.

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 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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dysport Injectable Product

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.

Group Type: EXPERIMENTAL

Dysport Injectable Product

Intervention Type: DRUG

Selected dose of medication will be determined by affected muscle(s), severity of spasticity, and the patient's body weight. We will follow the recommended total Dysport dose of 10-15 units/kg per limb, not to exceed 15 units/kg for unilateral lower limb, 30 units/kg for bilateral lower limb, or a total of 1000 units, whichever is lower in a given session.

Interventions

Dysport Injectable Product

Selected dose of medication will be determined by affected muscle(s), severity of spasticity, and the patient's body weight. We will follow the recommended total Dysport dose of 10-15 units/kg per limb, not to exceed 15 units/kg for unilateral lower limb, 30 units/kg for bilateral lower limb, or a total of 1000 units, whichever is lower in a given session.

Intervention Type: DRUG

Other Intervention Names

Botulinum toxin A

Eligibility Criteria

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heakyung Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University Medical Center- Department of Rehabilitation

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

AAAR1322

Identifier Type: -

Identifier Source: org_study_id