Evaluation of Macroscopic Muscle Growth in Infants and Young Children With Spastic Cerebral Palsy

NCT05197764 | Recruiting

• 1 other identifier: S62187
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

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). 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).

Conditions

Spastic Cerebral Palsy; Acquired Brain Injury

Keywords

Spastic Cerebral Palsy; Acquired Brain Injury; Brain imaging; 3D freehand ultrasound; Muscle morphology; Range of motion; Stiffness; Spasticity

Outcome Measures

Primary Outcomes (4)

• 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.

  Through a study participation of 2 years, with an evaluation moment every 6 months.

• 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.

  Through a study participation of 2 years, with an evaluation moment every 6 months.

• Overall change in muscle echo-intensity of the medial gastrocnemius muscle and the semitendinosus muscle.

  Estimation of the echo-intensity by 3DfUS.

  Through a study participation of 2 years, with an evaluation moment every 6 months.

• 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)

  Once during the study participation of 2 years.

Secondary Outcomes (8)

• Overall change of range of motion of the ankle and knee joint

  Through a study participation of 2 years, with an evaluation moment every 6 months.

• Overall change of spasticity of the medial gastrocnemius muscle and the semitendinosus muscle.

  Through a study participation of 2 years, with an evaluation moment every 6 months.

• Overall change of muscle strength of the medial gastrocnemius muscle and the semitendinosus muscle.

  Through a study participation of 2 years, with an evaluation moment every 6 months.

• Overall change of muscle selectivity of the medial gastrocnemius muscle and the semitendinosus muscle.

  Through a study participation of 2 years, with an evaluation moment every 6 months.

• Physiotherapy

  Through a study participation of 2 years, with an evaluation moment every 6 months.

Study Arms (3)

Children with spastic cerebral palsy

Children between 6 months and 9 years old.

Typically developing children

Children between 6 months and 9 years old.

Children with an acquired brain injury

Children between 1,5 years and 9 years.

Eligibility Criteria

• Age: 6 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Revalidatieziekenhuis Inkendaal: collaborator
• Universitaire Ziekenhuizen KU Leuven: lead
• Pulderbos revalidatiecentrum: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (11)

• Mockford M, Caulton JM. The pathophysiological basis of weakness in children with cerebral palsy. Pediatr Phys Ther. 2010 Summer;22(2):222-33. doi: 10.1097/PEP.0b013e3181dbaf96.

  PMID: 20473109 BACKGROUND

• Theis N, Mohagheghi AA, Korff T. Mechanical and material properties of the plantarflexor muscles and Achilles tendon in children with spastic cerebral palsy and typically developing children. J Biomech. 2016 Sep 6;49(13):3004-3008. doi: 10.1016/j.jbiomech.2016.07.020. Epub 2016 Jul 26.

  PMID: 27515440 BACKGROUND

• Gough M, Shortland AP. Could muscle deformity in children with spastic cerebral palsy be related to an impairment of muscle growth and altered adaptation? Dev Med Child Neurol. 2012 Jun;54(6):495-9. doi: 10.1111/j.1469-8749.2012.04229.x. Epub 2012 Feb 27.

  PMID: 22364585 BACKGROUND

• Mathewson MA, Lieber RL. Pathophysiology of muscle contractures in cerebral palsy. Phys Med Rehabil Clin N Am. 2015 Feb;26(1):57-67. doi: 10.1016/j.pmr.2014.09.005.

  PMID: 25479779 BACKGROUND

• Sarnat HB. Cerebral dysgeneses and their influence on fetal muscle development. Brain Dev. 1986;8(5):495-9. doi: 10.1016/s0387-7604(86)80093-6.

  PMID: 3541664 BACKGROUND

• Baldwin KM, Haddad F. Effects of different activity and inactivity paradigms on myosin heavy chain gene expression in striated muscle. J Appl Physiol (1985). 2001 Jan;90(1):345-57. doi: 10.1152/jappl.2001.90.1.345.

  PMID: 11133928 BACKGROUND

• Cenni F, Schless SH, Bar-On L, Aertbelien E, Bruyninckx H, Hanssen B, Desloovere K. Reliability of a clinical 3D freehand ultrasound technique: Analyses on healthy and pathological muscles. Comput Methods Programs Biomed. 2018 Mar;156:97-103. doi: 10.1016/j.cmpb.2017.12.023. Epub 2017 Dec 22.

  PMID: 29428080 BACKGROUND

• Haberfehlner H, Maas H, Harlaar J, Becher JG, Buizer AI, Jaspers RT. Freehand three-dimensional ultrasound to assess semitendinosus muscle morphology. J Anat. 2016 Oct;229(4):591-9. doi: 10.1111/joa.12501. Epub 2016 Jun 6.

  PMID: 27271461 BACKGROUND

• De Beukelaer N, Vandekerckhove I, Molenberghs G, Naulaers G, Thewissen L, Costamagna D, Van Campenhout A, Desloovere K, Ortibus E. Longitudinal trajectory of medial gastrocnemius muscle growth in the first years of life. Dev Med Child Neurol. 2024 Apr;66(4):531-540. doi: 10.1111/dmcn.15763. Epub 2023 Oct 3.

  PMID: 37786988 RESULT

• De Beukelaer N, Vandekerckhove I, Huyghe E, Molenberghs G, Peeters N, Hanssen B, Ortibus E, Van Campenhout A, Desloovere K. Morphological Medial Gastrocnemius Muscle Growth in Ambulant Children with Spastic Cerebral Palsy: A Prospective Longitudinal Study. J Clin Med. 2023 Feb 16;12(4):1564. doi: 10.3390/jcm12041564.

  PMID: 36836099 RESULT

• De Beukelaer N, Weide G, Huyghe E, Vandekerckhove I, Hanssen B, Peeters N, Uytterhoeven J, Deschrevel J, Maes K, Corvelyn M, Costamagna D, Gayan-Ramirez G, Van Campenhout A, Desloovere K. Reduced Cross-Sectional Muscle Growth Six Months after Botulinum Toxin Type-A Injection in Children with Spastic Cerebral Palsy. Toxins (Basel). 2022 Feb 14;14(2):139. doi: 10.3390/toxins14020139.

  PMID: 35202166 RESULT

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaat Desloovere, Prof. dr.

  Department of Rehabilitation Sciences, KU Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie De Beukelaer

CONTACT

+3216341016; Nathalie.debeukelaer@kuleuven.be

Lauraine Staut

CONTACT

lauraine.staut@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: January 19, 2022
• Study Start: February 11, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-10

Locations

BE (1)