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Clinical Trials in Sweden / NCT05447299
Enrolling by invitation Observational

Neuromusculoskeletal Modeling of Muscle Spasticity

NCT05447299 · tracked via the Priya Life Science Sweden tracker
Phase
Observational
Started
2019-01-15
Last updated
2022-07-07

Condition(s) studied

Cerebral PalsyMusculoskeletal DeformitySpasticityMuscle StrengthWalking, Difficulty

Study summary

Cerebral palsy (CP) is a movement and posture disorder caused by an injury to the developing brain, with a prevalence in Sweden of about 2/1000 live births. Children with CP have walking difficulties, and decreased muscle mass and muscle function as compared to typically developing (TD) children. The extent of disability in CP depends on the severity and timing of the primary cerebral lesion and can be classified with the gross motor function classification system (GMFCS E\&R) that ranges from walking without limitations (I) to being transported in a wheelchair (V).

Muscle function commonly deteriorates with age and contracture development is often clinically evident as early as at 4 years of age. In addition to being thinner and weaker, skeletal muscle in children with CP develop poor quality, i.e., increasingly higher amounts of fat and connective tissue at the expense of functional, contractile proteins.

How long-term standard treatments for children with spastic CP including, training and orthotics use, with botulinum toxin (BoNT-A) treatment as an adjunct, affects muscle on functional, structural, and microscopic level in CP has not yet been published. Therefore, we will investigate the muscle function as well as functional mobility, structure, and spasticity. We will conduct functional mobility tests. Muscle strength will be measured with a rig-fixed dynamometer, and muscle structure will be measured with magnetic resonance imaging. The spasticity will be instrumentally assessed by the NeuroflexorTM, a machine measuring resistance in a muscle when a pedal is passively moving the participants foot at two different speeds. We will follow participants, for 1 year, with 4 measurements during this period.

In order to better treat these children, we need to better understand the complex, interrelated interactions of musculoskeletal properties and function in children with CP. Our hypothesis is that muscle structure and function is affected by standard clinical treatments sessions including routine botulinum toxin treatment. Analyzing the effect of standard care may help planning of more effective clinical treatments in the future.

Eligibility

Sex
ALL
Min age
5 Years
Max age
18 Years
Healthy volunteers
No
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°

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Region Stockholm, Karolinska University Hospital Stockholm Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05447299 on ClinicalTrials.gov ↗ ← All trials in Sweden