Neuromusculoskeletal Modeling of Muscle Spasticity

Launched by REGION STOCKHOLM · Jul 1, 2022

Keywords

ClinConnect Summary

This is an observational study in Sweden that will look at how standard care for children with spastic cerebral palsy (CP) affects muscles and walking over time. About 90 participants are planned, including children with CP (ages 5–18 who have not yet received botulinum toxin injections) and a group of typically developing children for comparison. Children with CP will have four study visits: right before their first botulinum toxin (BoNT-A) injection, and then at 3, 6, and 12 months after that first treatment. They will undergo MRI scans to look at muscle structure, tests to measure spasticity (muscle stiffness), strength tests with a dynamometer, range-of-motion checks, and a walking/mobility test to see how long it takes to complete a simple walking task. The goal is to understand how muscle structure, strength, spasticity, and walking ability are connected and how standard treatment—including BoNT-A when used—affects these factors over a year.

Eligibility includes 5–18 year olds with unilateral or bilateral spastic CP who have not had BoNT-A injections, can bend the ankle so the foot can reach a neutral position, and can safely have an MRI. Those with MRI safety issues or very limited ankle movement are not eligible. A typically developing comparison group will also be recruited. The study is led from Karolinska University Hospital in Stockholm, funded by Region Stockholm with partners Karolinska Institutet and KTH Royal Institute of Technology. It is currently enrolling by invitation, with no results yet, and is expected to run through 2030. This is not a test of a new drug or device; it aims to improve understanding of how current care affects the muscles and walking in CP to guide future treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Unilateral/Bilateral spastic CP without Botulinum toxin injection history
• • Understanding study protocol and expressing voluntary consent of the family
• • Dorsiflexion to at least a neutral position of the foot
• Exclusion Criteria:
• • Contraindication to MRI scanning: metal fragments in the body, surgically implanted devices containing metal, severe claustrophobia, or inability to lie down in the MRI scanner, presence of pacemaker or other stimulators, shunts etc.
• • Total range of ankle movement less than 35°