NCT06330922 Muscle-tendon Pathology and Metabolic Dysregulation in CP
| NCT ID | NCT06330922 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Graz |
| Condition | Cerebral Palsy, Spastic |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-03-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-03-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 30 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.
Eligibility Criteria
Inclusion Criteria: * spastic cerebral palsy * mildly, moderately or severly affected (Gross Motor Function Classification System level I-IV) * age range 14 - 30 years * ability to accept and follow verbal instructions * strong communication skills * sufficient vision (visual function that enables safe movement with reference to people and obstacles) * less than 15 hours of experience with the Frame Runners; healthy peers in the same age range Exclusion Criteria: * other forms of cerebral palsy * orthopaedic surgery in the last 12 months * Botulinum toxin application in the last 6 months
Contact & Investigator
Annika Kruse, Dr.
PRINCIPAL INVESTIGATOR
Institute of Human Movement Science, Sport and Health, University of Graz
Frequently Asked Questions
Who can join the NCT06330922 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 30 Years, studying Cerebral Palsy, Spastic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06330922 currently recruiting?
Yes, NCT06330922 is actively recruiting participants. Contact the research team at annika.kruse@uni-graz.at for enrollment information.
Where is the NCT06330922 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT06330922 clinical trial?
NCT06330922 is sponsored by University of Graz. The principal investigator is Annika Kruse, Dr. at Institute of Human Movement Science, Sport and Health, University of Graz. The trial plans to enroll 50 participants.
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