Clinical Trials Logo

Clinical Trial Summary

The main aim of this project is to gain knowledge about the muscle-tendon pathology of moderately to severely affected young people with cerebral palsy and their risk for cardiometabolic diseases and chronic inflammation. Furthermore, it will be investigated whether there are associations between the existing pathophysiology as well as inactivity and muscle function, cardiometabolic risk factors and inflammation. Moreover, the potential of the target group for adaptation of its muscular, cardiorespiratory, and endocrine system will be investigated. The study parameters will be determined in adolescents and young adults aged 14 to 25 years with moderate to severe spastic cerebral palsy and compared with those of their less severely affected and healthy peers (cross-sectional study). In addition, the more affected individuals will participate in a 12-week training intervention (longitudinal study) performed with special tricycles (i.e., Frame Runners). To measure the study parameters, ultrasound, strength tests, near-infrared spectroscopy, blood analyses, and spiroergometry will be used. The fitness training will be performed two times a week for 12 weeks with the Frame Runners.


Clinical Trial Description

Background: Spastic cerebral palsy (CP) is a neuro-developmental disorder in children. Although the initial brain injury is not progressive, muscle pathology, a leading sign in affected individuals, is an on-going process. Individuals with CP are less physically active compared to their typically developing (TD) peers and severely affected individuals are most sedentary. Therefore, increased muscle wasting, decreased muscle function and cardiorespiratory fitness, metabolic dysregulation, and chronic low-grade inflammation might exist in the latter group. However, information is scarce and the role of muscle-tendon pathology and physical inactivity remains to be elucidated. Finally, it is unknown whether their tissues and organs may still adapt to health-inducing stimuli. Objectives: The main project aims are 1) to enhance our understanding of spastic muscle-tendon pathology, risk of cardiometabolic disease, and chronic inflammation likely present in young people with more severe spastic CP, and 2) to uncover the relationship of muscle-tendon alterations and physical inactivity on muscle function and metabolism as well as cardiometabolic risk factors and systemic inflammation. Moreover, the potential for adaptation of their muscular, cardiorespiratory, and endocrine system will be investigated. Methods: A cross-sectional study will be performed to compare severely impaired adolescents and young adults with spastic CP, their mildly affected CP and TD peers. The former group will further participate in a 12-week cardiorespiratory fitness training with Frame Runners. Muscle-tendon properties will be examined using ultrasound and shear wave elastography, and muscle function and metabolism with dynamometry and near infrared spectroscopy. Blood samples will be analyzed assessing metabolic parameters, and pro-inflammatory cytokines. Cardiorespiratory fitness will be investigated using the 6-Minute Frame Running Test and gas exchange analysis. Physical activity will be evaluated with accelerometers and activity diaries. Mental well-being and quality of life will be assessed by use of the CPCHILD™ questionnaire. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06330922
Study type Observational
Source University of Graz
Contact Annika Kruse, Dr.
Phone 00433163802329
Email annika.kruse@uni-graz.at
Status Recruiting
Phase
Start date March 8, 2024
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04530955 - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) N/A
Not yet recruiting NCT05131724 - Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy N/A
Completed NCT03005938 - Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy. N/A
Completed NCT04087330 - Whole-body Vibration in Spastic Hemiplegic Cerebral Palsy N/A
Completed NCT04570358 - Stretching in Children and Adolescents With Spastic Cerebral Palsy N/A
Completed NCT05945953 - Incentive Spirometer as a Visual Feedback in Children With Spastic Cerebral Palsy N/A
Completed NCT03209310 - The Effect of Trunk Control on Respiratory Muscle Strength N/A
Recruiting NCT03361930 - Changes in Muscle Activity of Children With Spastic Unilat Cerebral Palsy Using 2 Types of Ankle-foot Orthoses to Walk N/A
Recruiting NCT05593887 - Late-presenting Hip Dislocation in Non-ambulatory Children With Cerebral Palsy: A Comparison of Three Procedures N/A
Recruiting NCT03677843 - Multidimensional Approach in Patients With Severe Cerebral Palsy, Prospective Cohort(MAPCP Cohort)-Offline
Recruiting NCT03179241 - Outcome After Selective Dorsal Rhizothomy Concerning Life Quality, Cerebral Imaging and Cognition
Not yet recruiting NCT06434246 - Effect of Pully System on Hemiplegic Children N/A
Recruiting NCT05627921 - The Effect of Botulinum Toxin and ESWT Applications on Spasticity and Functionality in Cerebral Palsy Patients N/A
Completed NCT05102955 - Turkish Validity and Reliability of the Visual Function Classification System (VFCS)
Completed NCT05251532 - The Efficacy of Distortion Banding on Outcome Measures in Children With Cerebral Palsy N/A
Completed NCT05251519 - The Efficacy of Derotation Banding on Outcome Measures in Children With Cerebral Palsy N/A
Completed NCT05115695 - The Effect of Upper Extremity Strengthening on Functionality, Muscle Strength and Trunk in Children With Cerebral Palsy N/A
Completed NCT04240275 - Reliability of a Body-worn Sensor System for Gait Analysis in Children With CP
Not yet recruiting NCT05198921 - The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Spastic Diplegia Cerebral Palsy N/A
Completed NCT03212846 - Muscle Spasticity Reduction in Children With Cerebral Palsy by Means of Hippotherapy N/A