Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Intervention: Dysport Injectable Product
Intervention description: 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 MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Botulinum toxin A; Walking efficiency; Spasticity; Dysport; Pediatric

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.
    

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)