Region Stockholm, Karolinska University Hospital
Stockholm, Sweden
NCT Number: NCT05447299
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.
Interested in participating?
Request Info5 year–18 year
All sexes
Observational
Stockholm, Sweden
How long-term standard treatments for children with spastic cerebral palsy (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.
Research questions:
Participants with spastic CP, aged between 5-17 years, are recruited from the Dept of Pediatric Orthopaedics, when clinically motivated plans for the first BoNT-A treatment session of the calf (plantar flexors) are set. Typically developing children at same ages are recruited through convenient sample and will take part of the assessments once. The children with CP will go through the following assessments at four different time-points; before, 3 months, 6 months, and one year after the first BoNT-A injection:
Before the first injection, the children with CP will be examined with magnetic resonance imaging (MRI) providing complex 3D structural information of individual muscles. One year after first injection, another examination with MRI will be conducted.
This explorative, observational, prospective, long time follow up study will be conducted at the Motion analysis laboratory at Astrid Lindgren's children's hospital and Huddinge Karolinska in collaboration with KTH Royal Institute of Technology.
Parametric and/or non-parametric statistical tests for within and between group comparisons, and correlations will be performed. Based on the pilot data from TD children the CP group and previous literature we need a sample size of 10-15 participants in each group.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Before and one year after the first treatment session
MRI based examinations including muscle volume
Time frame: Before, three months, six months and 12 months after the firstt treatment session
Resistance at slow and fast passive movements of the foot
Time frame: Before, three months, six months and 12 months after the first treatment session
Muscle strength measured as force with a dynamomter in the calf muscle
Time frame: Before, three months, six months and 12 months after the first treatment session
Time to complete a test of functional mobility during walking will be measured
Region Stockholm
Other Gov
Neurobiomekaniska Modeller av Spasticitet Med hjälp av Personspecifika Muskelparametrar
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06696040
Brain Damage, Chronic, Brain Diseases
Caxias do Sul, Rio Grande do Sul, Brazil
View Trial DetailsNCT07715006
Brain Damage, Chronic, Brain Diseases
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT02199015
Articulation Disorders, Brain Damage, Chronic
La Plata, Buenos Aires, Argentina
View Trial DetailsNCT06454656
Brain Damage, Chronic, Brain Diseases
Balrath, Meath, Ireland
View Trial Details