Effect of Botulinum Toxin Type A on Functionality and Quality of Life in Children and Adolescents With Spastic Hemiparetic Cerebral Palsy GMFCS I-II at Teletón Santiago: A Prospective Single-Group Trial
Objective: To compare the results in functionality and quality of life before BoNT-A infiltration, at 4 weeks, and at 12 weeks, in children and adolescents diagnosed with cerebral palsy of the spastic hemiparesis type GMFCS I and II. Specific
Objectives: To evaluate the effect of the infiltration protocol on the functionality of the upper and lower limbs, and on the quality of life of the children and their families. Hypothesis The BoNT-A infiltration protocol has a positive effect on the functionality of the upper and lower limbs and on the quality of life of children with spastic cerebral palsy. Method The study is a prospective single-group trial, following participants over time to compare the results of the BoNT-A infiltration protocol. The target population includes children with spastic hemiparesis cerebral palsy GMFCS I-II referred to the botulinum toxin infiltration clinic at the Teletón Institute Santiago. A non-probabilistic convenience sampling will be used, selecting individuals who meet the inclusion and exclusion criteria. Procedure Patients will be selected and evaluated before infiltration, at 4 weeks, and at 12 weeks post-infiltration. The infiltration will be performed under ultrasound and electrostimulation guidance. Evaluations will include functionality and quality of life scales, such as the Ashworth Scale, Tardieu Scale, Bilan 400 Points Functional Hand Scale, GMFM-88, KIDSCREEN-27, and Goal Attainment Scale. Data Collection Data collection will be carried out through clinical record review, clinical observation, and application of scales. A homologation protocol will be implemented among operators to standardize the use of the scales. Variables Variables include age, sex, laterality, GMFCS, infiltrated muscles, infiltration dose, educational level, participation in a school integration program, physical activity, manual functionality, lower limb functionality, quality of life, and goal attainment. Statistical Analysis A database will be created in Microsoft Excel, and qualitative and quantitative variables will be analyzed. Chi-square tests, repeated measures ANOVA, and Friedman tests will be used to compare measurements over time. Ethical Considerations The study complies with ethical principles of scientific validity, social utility, researcher competence, favorable risk-benefit ratio, equitable selection of subjects, informed consent, and protection of the privacy and confidentiality of participants.
• Spastic hemiparesis type Cerebral Palsy
• Gross Motor Classification System I-II
• Age 8 to 17 years (based on validation ages for scales to be used)
• Minimum of 6 months since last botulinum toxin injection
• Informed consent signed by legal guardian and assent from users aged 12 to 17 years