Short Term Follow-up of a Botulinum Toxin Intervention in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
About this trial
This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Cerebral Palsy, Spastic Cerebral Palsy, Botulinum Toxin, muscle morphology, Range of motion, Stiffness, Spasticity, Intensive physical therapy
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of spastic cerebral palsy
- Aged 4-11 years
- GMFCS levels I-III (GMFCS = Gross Motor Function Classification Score, expressing the overall functional level of impairment)
- Sufficient cooperation to comprehend and complete the test procedure
- Additional exclusion criterion for the intervention group specifically: Indication for BoNT injections
Exclusion Criteria:
- Non-ambulatory
- Botulinum toxin A injections six months prior to enrollment
- Lower limb surgery two years prior to enrollment
- Previous selective dorsal rhizotomy
- Presence of ataxia or dystonia
- Cognitive problems that impede measurements
- Severe co-morbidities (severe epilepsy, non-correctable visual impairment, autism spectrum disorders, mental problems that prevent comprehensiveness of the tasks)
- Hospitalization after the BoNT treatment for intensive physical therapy
- Intrathecal baclofen pump
- For the control group: new intervention planned within 3 months
- Additional exclusion criterion for the control group specifically: new intervention planned within 3 months
Sites / Locations
- UZ LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention group
Control group
The children in the intervention group will receive BoNT injections in the medial gastrocnemius and/or the semitendinosus muscle(s). As part of the standard treatment approach of the CP Reference Centre of the University Hospitals Leuven, the injections are followed by a period of bilateral stretching casts if indicated (below the knee walking casts and removable knee extension casts when necessary) and all children will receive intensive physical therapy and application of ankle foot orthoses following BoNT injections. The follow-up period for the current study is 8-10 weeks. During this intensive physical therapy period post-BoNT, the children in the intervention group will work on individualized treatment goals, which will be defined based on the baseline measurements during a multidisciplinary discussion with the treating physician (that is scheduled prior to the BoNT injections).
This group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic management during a period of 8-10 weeks.