Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. This study will assess how effective OnabotulinumtoxinA is in treating pediatric participants with Spasticity. Change in disease activity will be evaluated. OnabotulinumtoxinA is approved drug for treatment of Spasticity. Approximately 106 pediatric participants aged 2-17 years with spasticity associated with cerebral palsy will be enrolled in approximately 10 sites across Mexico. Participants will receive OnabotulinumtoxinA as prescribed by their physician in accordance to local label and followed for 12 months. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits to a hospital or clinic in their routine practice.
Study Type
OBSERVATIONAL
Enrollment
107
Hospital General Regional 180 IMSS /ID# 261458
Guadalajara, Jalisco, Mexico
Clinica de Rehabilitacion Integral Yupi /Id# 261461
Puerto Vallarta, Jalisco, Mexico
Hospital General ISSSTE Tacuba /ID# 261460
Mexico City, Mexico City, Mexico
Hospital General ISSSTE Tacuba /ID# 261932
Mexico City, Mexico City, Mexico
Cree Dif Nuevo Leon /Id# 261454
Monterrey, Nuevo LEON, Nuevo León, Mexico
Hospital Militar De Zona De Villahermosa /ID# 261451
Villahermosa, Tabasco, Mexico
Cri Dif Jalisco /Id# 261459
Guadalajara, Mexico
Crit Estado de México /Id# 261934
Tlalnepantla, Mexico
Absolute Total Dose
OnabotulinumtoxinA total dose applied at visit will be assessed.
Time frame: Up to 12 months
Total Dose Per Kilogram
OnabotulinumtoxinA total dose applied at each visit, divided by patient's body weight will be assessed.
Time frame: Up to 12 months
Dose Per Muscle
OnabotulinumtoxinA dose applied to each muscle, regardless of punctures' number on that muscle will be assessed.
Time frame: Up to 12 months
Application Sites Number Per Muscle
Number of puncture sites per muscle will be assessed.
Time frame: Up to 12 months
Re-administration Interval
Re-administration interval is defined as number of days between drug application and previous application.
Time frame: Up to 12 months
Needle Gauge
Needle gauge is defined as diameter of needle thickness with which study treatment is applied.
Time frame: Up to 12 months
Needle Length
Needle length is defined as distance from the needle base to the needle bevel tip.
Time frame: Up to 12 months
Preventive Pain Management Technique
Type of method used to control procedural pain will be assessed.
Time frame: Up to 12 months
Method to Locate Application Site
Type of method used to identify muscle and treatment application site will be assessed.
Time frame: Up to 12 months
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