Botulinum toxin A injections to improve movement in children with spastic hemiparesis
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
NA · Instituto Teletón Chile · NCT07034547
This project will try botulinum toxin type A injections in children aged 8–17 with spastic hemiparesis (GMFCS I–II) to see if their motor function and quality of life improve.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | Instituto Teletón Chile (other) |
| Locations | 1 site (Santiago, Santiago Metropolitan) |
| Trial ID | NCT07034547 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-group intervention at Instituto Teletón Santiago testing a standardized botulinum toxin type A infiltration protocol in children and adolescents with spastic hemiparesis. The multidisciplinary team of physiatrists, kinesiologists, occupational therapists, and nurses will deliver injections and follow patients with functional and quality-of-life measures. Eligible participants are 8–17 years old, GMFCS I–II, and at least six months since any prior botulinum toxin injection. Outcomes will focus on changes in motor performance and daily functioning over the follow-up period.
Who should consider this trial
Good fit: Children and adolescents aged 8–17 with spastic hemiparesis cerebral palsy, GMFCS level I–II, able to follow functional assessments, and at least six months since their last botulinum toxin injection are ideal candidates.
Not a fit: Patients with significant cognitive impairment preventing assessments, joint limitations not due to spasticity, other causes of spasticity, other neuromuscular diseases, or those outside the specified age/GMFCS range are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the protocol could reduce spasticity and improve movement and daily functioning, enhancing quality of life for participants.
How similar studies have performed: Previous clinical work has shown that botulinum toxin type A can reduce spasticity and often improves function and participation, though protocols and measured benefits vary across studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Santiago, Santiago Metropolitan
- Instituto Teleton Santiago — Santiago, Santiago Metropolitan, Chile (RECRUITING)
Study contacts
- Study coordinator: Israel A Patino
- Email: israel.patino@teleton.cl
- Phone: +56967045412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy, Spasticity Due to Cerebral Palsy, Hemiparesis, botulinum toxin, quality of life, Physical Functional Performances