N/A
N=61
Short Term Follow-up of a Botulinum Toxin Intervention in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT05126693 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus — -0.08; 0.00; -0.09; -0.01 ml/kg*m
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Botulinum Toxin treatment combined with a post-BoNT intensive physical therapy period guided by individualized treatment goals. (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus |
-0.08; 0.00; -0.09; -0.01 | — |
| PRIMARY Change in Echogenicity Intensity of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus |
2.74; -0.08; 6.58; 5.20 | — |
| PRIMARY Absolute Muscle Volume Growth Rate of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus |
0.00; 0.17; -0.49; 0.02 | — |
| PRIMARY Change in Kinematic Parameters |
-1.74; 3.56; 3.99; 5.34; 1.94; -1.69 | — |
| PRIMARY Change in Gait Profile Score (Degrees) |
-1.76 | — |
| PRIMARY Change in the Spatial-temporal Parameter "Cadence". |
-0.05 | — |
| PRIMARY Change in the Spatial-temporal Parameter "Walking Velocity". |
0.01 | — |
| PRIMARY Change in the Spatial-temporal Parameter "Stride Length". |
0.02 | — |
| PRIMARY Change in Spasticity of the Medial Gastrocnemius and the Medial Hamstrings |
-4.73; -2.82 | — |
| SECONDARY Change in Normalized Muscle Tendon Unit Length of the Medial Gastrocnemius |
0.88; -0.35 | — |
| SECONDARY Change in Normalized Muscle Belly Length of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus |
0.44; -0.13; -0.32; -0.22 | — |
| SECONDARY Change in Normalized Tendon Length of the Medial Gastrocnemius |
-0.03; -0.26 | — |
| SECONDARY Normalized Muscle Volume Growth Rates of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus |
-0.02; 0.01; -0.02; -0.00 | — |
| SECONDARY Change in the Kinematic Parameter "Ankle Range of Motion in Sagittal Plane During Stance Phase" |
0.31 | — |
| SECONDARY Change in the Kinematic Parameter "Knee Range of Motion in Sagittal Plane During Stance Phase" |
3.68 | — |
| SECONDARY Change in Muscle Activation of the Medial Gastrocnemius and the Medial Hamstrings (i.e. the Change During the High-velocity Stretch). |
-2.64; -3.13 | — |
| SECONDARY Change of Range of Motion in the Ankle and Knee Joint |
0.0; 0.0 | — |
Summary
This study investigates the effect of integrated Botulinum Neurotoxin A (BoNT) treatment on morphologic muscle and tendon properties, spasticity, joint stiffness, joint range of motion, muscle strength, gait and gross motor function. The integrated BoNT treatment combines BoNT-injections with serial casting and intensive physical therapy, as previously described by Molenaers et al. The current study will include 30 children who are clinically scheduled for BoNT treatment in the medial gastrocnemius and/or the semitendinosus muscle in the intervention group and 30 children in a control group who will receive usual care within a time span of 3 months.
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
Data sourced from ClinicalTrials.gov (NCT05126693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.