N/A
N=49
Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy
Cerebral Palsy, Spastic
Bottom Line
View on ClinicalTrials.gov: NCT03863197 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Muscle Size Parameter — 3.7; 1.6; 1.4; 0.1 milliliters — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Progressive strength training (Behavioral)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Muscle Size Parameter |
3.7; 1.6; 1.4; 0.1; 2.0; 0.5 | <0.01 sig |
| PRIMARY Change in Muscle Length |
3.9; 5.5; 3.2; 3.0; 3.5; 2.4 | <0.01 sig |
| PRIMARY Change in Echogenicity Intensity |
-0.3; -0.1; 3.8; 3.2; 0.2; 1.8 | <0.01 sig |
| PRIMARY Change in Isometric Muscle Strength |
2.5; -0.4; 6.0; 0.8; 3.6; 1.1 | <0.01 sig |
| PRIMARY Change in Functional Muscle Strength - Muscle Endurance |
2.7; 0.3; 2.7; 1.1; 4.5; 3.6 | <0.01 sig |
| PRIMARY Change in Functional Muscle Strength - Maximum Jumping Distance |
5.8; 2.7 | <0.01 sig |
| SECONDARY Change in Gross Motor Function |
0.7; 0.3 | <0.01 sig |
| SECONDARY Change in Walking Capacity |
5.6; 3.6 | <0.01 sig |
Summary
A randomized controlled trail will be carried out to investigate the effect of a 12-week supervised home-based progressive strength intervention in children with spastic cerebral palsy aged 5-11 years. The results of this strength intervention aiming for increased strength and muscle hypertrophy will serve as input for a clinical decision making framework based on muscle and tendon architecture.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of SCP
- Aged 5-12 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
Exclusion Criteria
- Non-ambulatory
- Botulinum toxin A injections six months prior to enrollment
- Lower limb surgery two years prior to enrollment
- 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)
Data sourced from ClinicalTrials.gov (NCT03863197). 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.