Clinical trial Recruiting at 1 site Interventional Ages 8 to 17

Botulinum toxin A injections to improve movement in children with spastic hemiparesis

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

Run by Instituto Teletón Chile · NCT07034547 · Data updated 2026-11-12

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.

More Cerebral Palsy (CP) trials

Quick facts

Study typeInterventional
Ages8 Years to 17 Years
SexAll
Enrollment30 (estimated)
SponsorInstituto Teletón Chile
Academic / other
Locations1 site (Santiago, Santiago Metropolitan)
StatusRecruiting
StartedJune 11, 2025
Main results expectedJanuary 31, 2026
Study endsMay 30, 2026
Registry record updatedDecember 17, 2025
Trial IDNCT07034547 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Instituto Teleton Santiago
    Santiago, Santiago Metropolitan, Chile
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.