Muscle-tendon Pathology and Metabolic Dysregulation in CP
ConditionCerebral Palsy, Spastic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-30
SponsorUniversity of Graz
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
other forms of cerebral palsy
orthopaedic surgery in the last 12 months
Botulinum toxin application in the last 6 months
Trial population
The patient selection is based on the inclusion and exclusion criteria from the patient pool of the local clinic for Orthopaedics and Traumatology. In addition, other interested persons/families will be informed about the study via other clinics, (pediatric orthopedic) elective medical practices, rehabilitation centers and physiotherapy facilities within the city and the surrounding area.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Cardiorespiratory fitness training
Other interventionCardiorespiratory 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.
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Group 1: healthy individuals (cross-sectional study)0 interventions
Group B: Group 2: mildly affected individuals with cerebral palsy (cross-sectional study)0 interventions
Group C: Group 3: moderately and severely affected individuals with cerebral palsy (cross-sectional study)1 intervention
Trial outcomes
Primary outcomes
1
Muscle fascicle length and muscle thickness
cm
Time frame
Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)2
Muscle fascicle pennation angle
degrees
Time frame
Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)3
Passive muscle stiffness
kilopascal (kPa)
Time frame
Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)4
Isometric muscle strength
kg
Time frame
Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)Secondary outcomes
1
Metabolic parameters
Glucose, C-peptide, free fatty acids, cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein in mmol/l
Time frame
Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)2
Pro-inflammatory cytokines
e.g., Interleukin 6, tumor necrosis factor alpha in pg/ml
Time frame
Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)3
Resting, mean, and peak heart rate
beats/min
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)4
Resting blood pressure
mmHg
Time frame
Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)Other outcomes
1
Body height
cm
Time frame
Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)2
Body weight
kg
Time frame
Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)3
Body mass index (BMI)
Body height and weight will be combined to calculate the BMI in kg/m\^2
Time frame
Group 1 & 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)4
Modified Ashworth Scale Score of the Plantar flexors
number
Time frame
Group 2: baseline (T0); Group 3: baseline (T0), pre-measurement (T1, 13 weeks), post-measurement (T2, 27 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Graz
Lead sponsor
Medical University of Graz
Collaborator
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov