Status:
RECRUITING
Evaluation of Macroscopic Muscle Growth in Infants and Young Children With Spastic Cerebral Palsy
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Pulderbos revalidatiecentrum
Revalidatieziekenhuis Inkendaal
Conditions:
Spastic Cerebral Palsy
Acquired Brain Injury
Eligibility:
All Genders
6-9 years
Brief Summary
A mixed longitudinal design study will be carried out to explore the onset and time course of morphological muscle changes on a macroscopic level in children with spastic cerebral palsy (SCP). Therefo...
Detailed Description
Background: Recent literature reviews have emphasized the need for longitudinal studies with multiple measurement time- points to properly identify the natural course of muscle growth in young childr...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of spastic cerebral palsy or patients at high-risk for spastic cerebral palsy
- Suspected GMFCS levels I-III (GMFCS = Gross Motor Function Classification Scale, expressing the overall functional level of impairment)
Exclusion
- Non-ambulatory
- Botulinum neurotoxin type-A injections six months prior to enrollment
- Lower limb surgery two years prior to enrollment
- Muscle surgery at the muscles in the lower limb
- Selective dorsal rhizotomy as treatment history
- Presence of ataxia or dystonia
- Severe co-morbidities (severe epilepsy, severe behavior problems that impede the cooperation)
Key Trial Info
Start Date :
February 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT05197764
Start Date
February 11 2019
End Date
December 1 2026
Last Update
April 30 2025
Active Locations (1)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000