Ireland
--:--IST
Recruiting Observational

Muscle-tendon Pathology and Metabolic Dysregulation in CP

NCT06330922 · tracked via the Priya Life Science Austria tracker
Phase
Observational
Started
2024-03-08
Last updated
2026-04-29

Condition(s) studied

Cerebral Palsy, Spastic

Investigational drug(s) / intervention(s)

Cardiorespiratory fitness training

Cardiorespiratory fitness training: Cardiorespiratory fitness training will be performed two times a week for one hour in small groups (4-5 people). The training will be conducted outdoors at track and field facilities with at least two coaches.

Study 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

Sex
ALL
Min age
14 Years
Max age
30 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Muscle fascicle length and muscle thickness — Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)
    cm
  • Muscle fascicle pennation angle — Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)
    degrees
  • Passive muscle stiffness — Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)
    kilopascal (kPa)
  • Isometric muscle strength — Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)
    kg
  • Muscle tissue oxygenation — Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)
    Tissue saturation index (TSI)
  • Exosome size — Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)
    nanometers (nm)
  • Exosome content — Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)
    number/ml
  • Micro ribonucleic acid (RNA) cargo — Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)
    expression level

Trial sites (1)

FacilityCityRegionStatus
Institute of Human Movement Science, Sport and Health, University of Graz Graz Austria Recruiting
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 NCT06330922 on ClinicalTrials.gov ↗ ← All trials in Austria