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Search / Trial NCT04904094

Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · May 21, 2021

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Cerebral Palsy Spastic Cerebral Palsy Stretching Intervention Muscle Morphology Range Of Motion Stiffness Spasticity

ClinConnect Summary

This clinical trial is looking at a new approach to help children with spastic cerebral palsy improve their movement and muscle function. The study involves a 6-week stretching program that starts with a 2-week period of casting (using a soft cast to help stretch the muscles) followed by a home-based stretching routine. Researchers want to see how this program affects muscle and tendon length, flexibility, stiffness, and overall strength in children between the ages of 4 and 11 who have a certain level of mobility.

To participate in this study, children must have a confirmed diagnosis of spastic cerebral palsy and score between I and III on the Gross Motor Function Classification Score (which measures their ability to move). They should be able to understand instructions and cooperate during the tests. However, children who are non-ambulatory (unable to walk), have had specific treatments or surgeries recently, or have certain other medical conditions will not be eligible. If selected, participants can expect to engage in a structured program designed to enhance their muscle function, with the goal of improving their overall mobility and quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Confirmed diagnosis of spastic cerebral palsy
  • Aged 4-12 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
  • Indication for casting of the lower limb
  • Exclusion Criteria:
  • Non-ambulatory
  • Botulinum toxin A injections six months prior to enrollment
  • Lower limb surgery two years prior to enrollment
  • Selective dorsal rhizotomy as treatment history
  • 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)

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, , Belgium

Patients applied

0 patients applied

Trial Officials

Kaat Desloovere, prof. dr.

Study Director

KU Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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