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
This trial accepts healthy volunteersQualifiers
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 population
Children with spastic cerebral palsy, who have routine follow-up care at the CP reference center of the University Hospitals Leuven, the rehabilitation centers of Pulderbos and/or Inkendaal
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
229 Participants
are grouped into 3 trial groupsGroup A: Children with spastic cerebral palsy
Group B: Typically developing children
Group C: Children with an acquired brain injury
Trial outcomes
Primary outcomes
1
Overall change in muscle volume of the medial gastrocnemius muscle and the semitendinosus muscle
Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth.
Time frame
Through a study participation of 2 years, with an evaluation moment every 6 months.2
Overall change in muscle length of the medial gastrocnemius muscle and the semitendinosus muscle.
Estimation of the muscle belly length, tendon length and muscle tendon unit complex length by 3DfUS. Muscle lengths will be normalized to anthropometric growth.
Time frame
Through a study participation of 2 years, with an evaluation moment every 6 months.3
Overall change in muscle echo-intensity of the medial gastrocnemius muscle and the semitendinosus muscle.
Estimation of the echo-intensity by 3DfUS.
Time frame
Through a study participation of 2 years, with an evaluation moment every 6 months.4
Evaluation of the brain lesion based on MRI imaging
Estimation of the type, extend and location of the brain lesion by MRI imaging assessment tool (Fiori scale)
Time frame
Once during the study participation of 2 years.Secondary outcomes
1
Overall change of range of motion of the ankle and knee joint
Evaluation by goniometry
Time frame
Through a study participation of 2 years, with an evaluation moment every 6 months.2
Overall change of spasticity of the medial gastrocnemius muscle and the semitendinosus muscle.
Evaluation by Modified Ashworth Scale. This scale has a score from 0 to 4. If the score is higher, the muscle has more spasticity.
Time frame
Through a study participation of 2 years, with an evaluation moment every 6 months.3
Overall change of muscle strength of the medial gastrocnemius muscle and the semitendinosus muscle.
Evaluation by manual muscle testing with a score from 0 to 5. If the score is higher, the muscle is stronger.
Time frame
Through a study participation of 2 years, with an evaluation moment every 6 months.4
Overall change of muscle selectivity of the medial gastrocnemius muscle and the semitendinosus muscle.
Evaluation by Selective Control Assessment of the Lower Extremity (SCALE) clinical tool. This scale has a score from 0 to 2. If the score is higher, the muscle selectivity is better.
Time frame
Through a study participation of 2 years, with an evaluation moment every 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Pulderbos revalidatiecentrum
Collaborator
Revalidatieziekenhuis Inkendaal
Collaborator
Source ClinicalTrials.gov