Evaluation of Macroscopic Muscle Growth in Infants and Young Children With Spastic Cerebral Palsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-9
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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). Therefore, this project aims to (1) describe the macroscopic morphological muscle changes with increasing age and (2) evaluate the onset and development of muscle alterations in relation to the brain lesion (e.g., timing, extent and location), to the neuromuscular impairments and to treatment. Overall, this project will evaluate the macroscopic muscle properties by means of 3D freehand ultrasound (3DfUS).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
229 Participants
are grouped into 3 trial groupsSponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Pulderbos revalidatiecentrum
Collaborator
Revalidatieziekenhuis Inkendaal
Collaborator
Source ClinicalTrials.gov