Cerebral Palsy
Conditions
Keywords
Botulinum Toxin-A
Brief summary
Clinical guidelines recommend the use of Botulinum Toxin-A (BoNT-A) for localized/segmental spasticity in children with cerebral palsy. At the Kocaeli University (KOU) Department of Physical Medicine and Rehabilitation (PMR) more than 800 patients have been injected with the two approved toxinA types; OnabotulinumtoxinA or AbobotulinumtoxinA. With this study investigators would like to evaluate retrospectively if switching from one toxin to another is safe as well as to evaluate if the efficacy when switching from one toxin to another was maintained.
Detailed description
A data base was designed to capture all data that were considered relevant to the treatment evaluation. The data were transcribed directly from participants medical records. For the purpose of the study, data from the two subsequent visits where a different type of toxin was given will be collected and evaluated . In order to collect the pre and post status in terms of safety and efficacy, for each participant, data corresponding to the 6 previous and posterior months after the switch of the toxin will also be collected or data corresponding to the previous and posterior visit after the switch of the toxin will also be collected.
Interventions
DRUGBotulinum toxin type A
Botulinum toxin type A
Sponsors
Nigar Dursun
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Inclusion criteria
* children diagnosis of cerebral palsy with respect to Rosenbaum criteria, * children having received repeated injections with two different types of toxinA treatment into their lower limb(s)
Exclusion criteria
* children without repeated Botulinum toxin type A injections * children having received repeated injections with same type of toxinA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of treatment related adverse events | Up to 30 months | Overall and per injection cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale | Up to 30 months | Spasticity Assessment Scale |
| Tardieu Scale | Up to 30 months | Spasticity Assessment Scale |
| Observational Gait Scale | Up to 30 months | Gait Assessment Scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Goal Attainment Scale | Up to 30 months | Outcome measure for goal selection and goal scaling |
Countries
Turkey (Türkiye)
Outcome results
None listed