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NCT Number: NCT06330922

Muscle-tendon Pathology and Metabolic Dysregulation in CP

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.

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Key information

Age range

14 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Human Movement Science, Sport and Health, University of Graz

Graz, 8010, Austria

Location status: Recruiting

Location contact

Sebastian Ruin, Univ.-Prof.

CONTACT

[email protected]

00433163802336

About this study

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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiorespiratory fitness training

Other

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.

Other names: Frame Running

Primary outcomes

  1. Muscle fascicle length and muscle thickness

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    cm

  2. Muscle fascicle pennation angle

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    degrees

  3. Passive muscle stiffness

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    kilopascal (kPa)

  4. Isometric muscle strength

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    kg

  5. Muscle tissue oxygenation

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    Tissue saturation index (TSI)

  6. Exosome size

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    nanometers (nm)

  7. Exosome content

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    number/ml

  8. Micro ribonucleic acid (RNA) cargo

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    expression level

Secondary outcomes

  1. Metabolic parameters

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    Glucose, C-peptide, free fatty acids, cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein in mmol/l

  2. Pro-inflammatory cytokines

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    e.g., Interleukin 6, tumor necrosis factor alpha in pg/ml

  3. Resting, mean, and peak heart rate

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), measurement after 6 weeks of training (T1_6weeks, 20 weeks), post-measurement (T2, 27 weeks)

    beats/min

  4. Resting blood pressure

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    mmHg

  5. Distance covered

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), measurement after 6 weeks of training (T1_6weeks, 20 weeks), post-measurement (T2, 27 weeks)

    m

  6. Peak oxygen uptake (VO2peak), Peak ventilation (VEpeak)

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), measurement after 6 weeks of training (T1_6weeks, 20 weeks), post-measurement (T2, 27 weeks)

    l/min

  7. Peak respiratory frequency

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), measurement after 6 weeks of training (T1_6weeks, 20 weeks), post-measurement (T2, 27 weeks)

    breaths/min

  8. Respiratory exchange ratio

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), measurement after 6 weeks of training (T1_6weeks, 20 weeks), post-measurement (T2, 27 weeks)

    peak carbon dioxide production (VCO2peak)/VO2peak

  9. VEpeak/VO2peak

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), measurement after 6 weeks of training (T1_6weeks, 20 weeks), post-measurement (T2, 27 weeks)

    ratio

  10. VEpeak/VCO2peak

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), measurement after 6 weeks of training (T1_6weeks, 20 weeks), post-measurement (T2, 27 weeks)

    ratio

  11. Perceived exertion

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), measurement after 6 weeks of training (T1_6weeks, 20 weeks), post-measurement (T2, 27 weeks)

    6-20 Borg Scale

  12. Well-being and quality of life

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™) questionnaire

  13. Total physical activity, time spent in different intensities

    Time frame: Group 1 & 2: within 1 week between familiarisation and baseline (T0); Group 3: within 1 week after baseline (T0), within 1 week after post-measurement (T2, 28 weeks)

    min

  14. Passive range of motion (sagittal plane) of hip, knees, ankles

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    degrees

  15. Step count

    Time frame: Group 1 & 2: within 1 week between familiarisation and baseline (T0); Group 3: within 1 week after baseline (T0), within 1 week after post-measurement (T2, 28 weeks)

    number

Other outcomes

  1. Body height

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    cm

  2. Body weight

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    kg

  3. Body mass index (BMI)

    Time frame: Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    Body height and weight will be combined to calculate the BMI in kg/m^2

  4. Modified Ashworth Scale Score of the Plantar flexors

    Time frame: Group 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)

    number

Study contacts

Contact information is provided by the study sponsor or research team.

Annika Kruse, Dr.

CONTACT

[email protected]

00433163802329

Martin Svehlik, Dr. med.

CONTACT

[email protected]

004331638514129

Sponsors and collaborators

Lead sponsor

University of Graz

Other

Collaborators

  • Karolinska Institutet
  • Medical University of Graz

Registry information

Official study title

Muscle-tendon Pathology, Metabolic Dysregulation and Chronic Inflammation in Adolescents and Young Adults With Moderate to Severe Spastic Cerebral Palsy

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 26, 2024
Registry last updated
Apr 29, 2026

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.

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