Spastic equinus in children with Cerebral Palsy PrabotulinumtoxinA, Cerebral Palsy, Spasticity, Spastic equinus, Equinus foot, Pediatric lower limb spasticity
Conditions
Interventions
Participants will receive a single session of ultrasound guided intramuscular injection of PrabotulinumtoxinA (NABOTA) for treatment of spastic equinus associated with Cerebral Palsy. Prabotulinumtoxi
Experimental Drug
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosed with Cerebral Palsy with lower limb spasticity (monoplegia, hemiplegia, paraplegia, or quadriplegia), 2.Presence of spastic equinus foot during the stance phase of gait, 3.Able to ambulate with or without assistive devices (GMFCS levels I to III), 4.No previous botulinum toxin type A, alcohol, or phenol injection to the lower limbs within the past 4 months, 5.Stable rehabilitation regimen (physical therapy, occupational therapy, orthoses, and oral medications) for at least 1 month before enrollment, 6.Written informed consent obtained from parents or legal guardian
Exclusion criteria
Exclusion criteria: 1.Fixed myocontracture of the ankle (passive ankle dorsiflexion less than 80 degree by Tardieu Scale where 90 degree represents the neutral position, angles less than 90 degree indicate plantarflexion, and angles more than 90 degree indicate dorsiflexion), 2.Use of medications that interferes with neuromuscular function (eg, aminoglycoside or neuroblocking agents used during surgery) within 30 days before enrollment, 3.Presence of medical conditions that may increase the risk of botulinum toxin injection, such as Myasthenia Gravis, Lambert Eaton syndrome, or Amyotrophic Lateral Sclerosis, 4.History of serial casting within 6 months before enrollment, 5.Use of dynamic splinting within 3 months before enrollment, 6.Known hypersensitivity or allergy to botulinum toxin type A, 7.Pregnancy, possibility of pregnancy, or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ankle dorsiflexion R1 angle at 1,3,6 months after the intervention Change in ankle dorsiflexion R1 angle measured by goniometer | — |
Secondary
| Measure | Time frame |
|---|---|
| Spasticity at 1,3,6 months after the intervention Change in ankle plantarflexor Modified Ashworth Scale,Initial foot contact at 1,3,6 months after the intervention Grading of initial foot contact using video gait analysis,Ankle clonus at 1,3,6 months after the intervention Presence of ankle clonus,Pain at 1,3,6 months after the intervention FLACC scale(2-3year), Face Pain Scale-Revised(4-7year), or Numeric Rating Scale(8-17year) ,Gait speed at 1,3,6 months after the intervention Gait speed(10 meter walking test with or without gait aid),Adverse events During injection, at 30 minutes and at 1,3,6 months after the intervention Assessment of adverse events after injection | — |
Countries
Thailand
Contacts
Public ContactSupisara Supipetch
Phramongkutklao hospital
Outcome results
None listed