Cerebral Palsy (CP)NCT07034547
Effect of Botulinum Toxin Type A on Motor Function in Children With Cerebral Palsy
A study testing Botulinum toxin infiltration in people with Cerebral Palsy (CP) and Spasticity Due to Cerebral Palsy, run by Instituto Teletón Chile at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Cerebral Palsy (CP), Spasticity Due to Cerebral Palsy, Hemiparesis
- What is being tested?
- Botulinum toxin infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 11 Jun 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Instituto Teleton Santiago
Santiago, Santiago Metropolitan, 9160000
Israel A Patino, +56967045412, israel.patino@teleton.cl
Diego Rocha, +56998177183, diego.rocha@teleton.cl
About this study
Official title: 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
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.
Read more
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.
- Being tested
- Botulinum toxin infiltration
- Keywords
- botulinum toxin, quality of life, Physical Functional Performances
- Medical subject headings
- Cerebral Palsy, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin infiltrationProcedure or surgery
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 | Role | What they receive |
|---|---|---|
| Study group | Experimental | Children Aged 8-17 With Spastic Hemiparetic Cerebral Palsy Treated With Botulinum Toxin Type A Receives: Procedure: Botulinum toxin infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks after intervention
Secondary outcomes (3)
Goniometry
Goniometry is a technique used to measure the range of motion of joints. It is based on measuring joint mobility angles, and its results help identify joint limitations. Ranges of motion are classified as active, passive, or assisted, depending on the degree of patient involvement in the movement. The values obtained are expressed in degrees (°), and each joint has a normal reference range. For example, elbow flexion typically ranges from 0° to 150°. Values within the normal range indicate adequate functional mobility; values below may reflect stiffness, contractures, or limitations, while values above the expected range may suggest hypermobility or joint instability.
Measured: Baseline, 4 weeks, and 12 weeks after intervention
Ashworth Scale
The Ashworth Scale is a diagnostic tool used to measure muscle tone in patients with spasticity. It assigns a score from 0 to 4 based on the resistance to passive movement of a joint. The scores are: 0: No increase in muscle tone, 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion, 2: More marked increase in muscle tone through most of the range of motion, but the affected part is easily moved, 3: Considerable increase in muscle tone, passive movement difficult, 4: Affected part rigid in flexion or extension.
Measured: Baseline, 4 weeks, and 12 weeks after intervention
Tardieu Scale
The Tardieu Scale is used to assess spasticity in patients with neurological conditions by evaluating muscle response at different stretch speeds and measuring the spasticity angle. It includes two components: the quality of muscle reaction and the angle of reaction. The quality is scored from 0 to 5, where 0 means no resistance, 1 slight resistance, 2 a clear stop with release, 3 a sustained or clonic contraction under 10 seconds, 4 sustained over 10 seconds, and 5 a fixed joint. The angle of reaction (R1) is the point of first resistance during a fast stretch and is compared to the maximum passive range (R2). A greater difference between R2 and R1 indicates more dynamic spasticity, while similar values suggest a fixed contracture.
Measured: Baseline, 4 weeks, and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start11 Jun 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Teletón Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034547
- Sponsor's protocol ID
- TeletonChile
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared, as the participants belong to a vulnerable population and the information is considered sensitive and not appropriate for public dissemination
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07034547
- Acronym / sponsor ID
- TeletonChile
- Keywords
- botulinum toxin, quality of life, Physical Functional Performances
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto Teletón ChileUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Botulinum toxin infiltrationChildren Aged 8-17 With Spastic Hemiparetic Cerebral Palsy Treated With Botulinum Toxin Type A |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin infiltrationBotulinum 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. | Procedure or surgery | Study group |
Primary outcome
Bilan 400 Points Functional Hand Scale
Time frame: Baseline, 4 weeks, and 12 weeks after intervention
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.
Gross Motor Function Measure (GMFM-88). D and E dimensions
Time frame: Baseline, 4 weeks, and 12 weeks after intervention
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.
KIDSCREEN-27
Time frame: Baseline and 12 weeks after intervention
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.
Goal Attainment Scale
Time frame: Baseline and 12 weeks after intervention
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.
3 secondary outcomes
Goniometry
Time frame: Baseline, 4 weeks, and 12 weeks after intervention
Ashworth Scale
Time frame: Baseline, 4 weeks, and 12 weeks after intervention
Tardieu Scale
Time frame: Baseline, 4 weeks, and 12 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared, as the participants belong to a vulnerable population and the information is considered sensitive and not appropriate for public dissemination
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin infiltration in people with Cerebral Palsy (CP) and Spasticity Due to Cerebral Palsy, run by Instituto Teletón Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Israel A Patino (+56967045412, israel.patino@teleton.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilan 400 Points Functional Hand Scale (time frame: Baseline, 4 weeks, and 12 weeks after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.