Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebr… (NCT03469999) | Clinical Trial Compass
CompletedPhase 3
Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy
United States12 participantsStarted 2018-12-12
Plain-language 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.
Who can participate
Age range5 Years – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 orthot…
What they're measuring
1
Oxygen Consumption (ml/kg/Min)
Timeframe: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection