Effect of Botulinum Toxin Type A on Motor Function in Children With Cerebral Palsy

NCT07034547 | Recruiting

• 1 other identifier: TeletonChile
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Project Identification and Researchers Title: "Changes in functionality and quality of life when applying the botulinum toxin type A infiltration protocol in children and adolescents with cerebral palsy of the spastic hemiparesis type GMFCS I and II, from the Teletón Institute Santiago: A prospective single-group trial." This project is led by a group of physiatrists from the Teletón Institute, along with a team of co-investigators specialized in kinesiology, occupational therapy, and nursing. Study Relevance The study aims to generate scientific evidence on the effectiveness of the BoNT-A infiltration protocol in the functionality and quality of life of children with spastic hemiparesis. The results could optimize therapeutic interventions at the Teletón Institute, improve patient well-being, and expand the coverage of therapeutic services for spasticity. Problem Statement Cerebral palsy (CP) is the most common motor disability in childhood, with an estimated prevalence of 1.6 per 1,000 live births in developed countries and between 1 and 2 per 1,000 live births in Chile. Spastic CP requires multidisciplinary management, including BoNT-A infiltration. Although BoNT-A has been shown to reduce spasticity, there is a gap in knowledge regarding its impact on overall functionality and quality of life. Research Question What changes occur in functionality and quality of life when applying the BoNT-A infiltration protocol from the Teletón Institute Santiago in children aged 8 to 17 years, diagnosed with cerebral palsy of the spastic hemiparesis type GMFCS I and II? Study Objectives General 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.

Conditions

Cerebral Palsy (CP); Spasticity Due to Cerebral Palsy; Hemiparesis

Keywords

botulinum toxin; quality of life; Physical Functional Performances

Outcome Measures

Primary Outcomes (4)

• Bilan 400 Points Functional Hand Scale

  The Bilan 400 Points Functional Hand Scale is an assessment tool used to measure hand functionality in patients with neuro-musculoskeletal disabilities. This scale is primarily applied to children and adolescents aged 7 to 17 years and evaluates four key dimensions: hand mobility, grip strength, monomanual grasp and object displacement, and bimanual function. Each of these dimensions is scored out of 100 points, totaling 400 points. The scale is useful for quantifying the degree of use of an injured hand and for objectifying the impact of therapeutic interventions. In the Bilan 400 Points Functional Hand Scale, higher scores (close to 400) indicate good or normal hand functionality, while lower scores (close to 0) reflect very limited or severely impaired functionality.

  Baseline, 4 weeks, and 12 weeks after intervention

• Gross Motor Function Measure (GMFM-88). D and E dimensions

  The GMFM-88 is a standardized tool for assessing changes in gross motor function in children with cerebral palsy. It includes 88 items across five dimensions. Dimensions D and E focus on standing and walking-related tasks. Dimension D evaluates the ability to stand independently, including standing on one leg and transitioning from sitting to standing. Dimension E assesses walking, running, and jumping, such as walking forward, running, and jumping over obstacles. Each item is scored from 0 to 3. Higher scores (close to 100%) indicate better gross motor function and greater independence, while lower scores (close to 0%) reflect significant limitations in performing the evaluated tasks.

  Baseline, 4 weeks, and 12 weeks after intervention

• KIDSCREEN-27

  The KIDSCREEN-27 is a mid-length questionnaire designed to assess health-related quality of life (HRQoL) in children and adolescents aged 8-18. It includes 27 items across five dimensions: physical well-being, psychological well-being, autonomy and parent relations, social support and peer relations, and school environment. It is ideal when HRQoL is relevant but not the main focus of a study, or when the full version is too long. Each item uses a 5-point Likert scale to measure frequency or intensity of experiences. Responses are converted to scores from 0 (poorest HRQoL) to 100 (best HRQoL). Higher scores indicate better perceived quality of life in each dimension.

  Baseline and 12 weeks after intervention

• Goal Attainment Scale

  The Goal Attainment Scale (GAS) is an individualized assessment tool used to document and score the extent to which a patient achieves their personal goals during an intervention. Each patient sets unique goals, which are formulated using the SMART approach (specific, measurable, achievable, relevant, and time-bound). These goals are rated on a five-point scale: +2 indicates the outcome was much better than expected, +1 somewhat better, 0 exactly as expected, -1 somewhat less than expected, and -2 much worse than expected. This standardized scoring allows for statistical analysis of results and helps tailor interventions to the individual needs of the patient. An average score close to 0 indicates that goals were achieved as planned, while positive values reflect better-than-expected performance and negative values indicate underperformance.

  Baseline and 12 weeks after intervention

Secondary Outcomes (3)

• Goniometry

  Baseline, 4 weeks, and 12 weeks after intervention

• Ashworth Scale

  Baseline, 4 weeks, and 12 weeks after intervention

• Tardieu Scale

  Baseline, 4 weeks, and 12 weeks after intervention

Study Arms (1)

Study group

EXPERIMENTAL

Children Aged 8-17 With Spastic Hemiparetic Cerebral Palsy Treated With Botulinum Toxin Type A

Procedure: Botulinum toxin infiltration

Interventions

Botulinum toxin infiltration PROCEDURE

Botulinum toxin is a medication that is injected directly into the muscles selected by a physiatrist, based on a clinical evaluation. The doses are determined according to the clinical condition of the spasticity, the patient's age, and weight. The procedure is performed under deep sedation and uses ultrasound and electrostimulation to ensure greater safety and precision.

Study group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment that prevents following instructions for functional assessments
• Limitation of joint range not caused by spasticity
• Patients diagnosed with other diseases causing spasticity, different from cerebral palsy
• Patients with other neuromuscular diseases

Sponsors & Collaborators

• Instituto Teletón Chile: lead

Study Sites (1)

Instituto Teleton Santiago

Santiago, Santiago Metropolitan, 9160000, Chile

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Paresis

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Israel A Patino

CONTACT

+56967045412; israel.patino@teleton.cl

Manuel J Duran

CONTACT

+56952577100; manuel.duran@teleton.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 24, 2025
• Study Start: June 11, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)