Muscle-tendon Pathology and Metabolic Dysregulation in CP

NCT06330922 | Recruiting

• 1 other identifier: 10.55776/V992
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral Palsy; Spasticity; Cardiorespiratory Fitness; Frame Running; Muscle

Outcome Measures

Primary Outcomes (8)

• Muscle fascicle length and muscle thickness

  cm

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

• Muscle fascicle pennation angle

  degrees

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

• Passive muscle stiffness

  kilopascal (kPa)

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

• Isometric muscle strength

  kg

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

• Muscle tissue oxygenation

  Tissue saturation index (TSI)

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

• Exosome size

  nanometers (nm)

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

• Exosome content

  number/ml

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

• Micro ribonucleic acid (RNA) cargo

  expression level

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

Secondary Outcomes (15)

• Metabolic parameters

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

• Pro-inflammatory cytokines

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

• Resting, mean, and peak heart rate

  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)

• Resting blood pressure

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

• Distance covered

  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)

Other Outcomes (4)

• Body height

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

• Body weight

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

• Body mass index (BMI)

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

Study Arms (3)

Group 1: healthy individuals (cross-sectional study)

Typically developed adolescents and young adults will be recruited and measured once within the cross-sectional study.

Group 2: mildly affected individuals with cerebral palsy (cross-sectional study)

Mildly affected adolescents and young adults will be recruited and measured once within the cross-sectional study.

Group 3: moderately and severely affected individuals with cerebral palsy (cross-sectional study)

The results of the baseline assessment (T0) of the adolescents and young adults with moderate to severe cerebral palsy will be compared with group 1 and group 2. After the baseline assessment (T0) also used for the group comparison (see description above), group 3 enters a 12-week control period following daily routines. After the 12 weeks, the individuals will be assessed (T1) and will then start with the 12-week cardiorespiratory fitness training. The final assessment (T2) will terminate study participation of group 3.

Other: Cardiorespiratory fitness training

Interventions

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.

Also known as: Frame Running

Group 3: moderately and severely affected individuals with cerebral palsy (cross-sectional study)

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• other forms of cerebral palsy
• orthopaedic surgery in the last 12 months
• Botulinum toxin application in the last 6 months

Sponsors & Collaborators

• University of Graz: lead
• Medical University of Graz: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

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

Graz, 8010, Austria

RECRUITING

Related Publications (6)

• Bell KJ, Ounpuu S, DeLuca PA, Romness MJ. Natural progression of gait in children with cerebral palsy. J Pediatr Orthop. 2002 Sep-Oct;22(5):677-82.

  PMID: 12198474 BACKGROUND

• Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.

  PMID: 27188686 BACKGROUND

• Narayanan UG, Fehlings D, Weir S, Knights S, Kiran S, Campbell K. Initial development and validation of the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD). Dev Med Child Neurol. 2006 Oct;48(10):804-12. doi: 10.1017/S0012162206001745.

  PMID: 16978459 BACKGROUND

• Nooijen CF, Slaman J, Stam HJ, Roebroeck ME, Berg-Emons RJ; Learn2Move Research Group. Inactive and sedentary lifestyles amongst ambulatory adolescents and young adults with cerebral palsy. J Neuroeng Rehabil. 2014 Apr 3;11:49. doi: 10.1186/1743-0003-11-49.

  PMID: 24708559 BACKGROUND

• Verschuren O, Peterson MD, Balemans AC, Hurvitz EA. Exercise and physical activity recommendations for people with cerebral palsy. Dev Med Child Neurol. 2016 Aug;58(8):798-808. doi: 10.1111/dmcn.13053. Epub 2016 Feb 7.

  PMID: 26853808 BACKGROUND

• Howard JJ, Herzog W. Skeletal Muscle in Cerebral Palsy: From Belly to Myofibril. Front Neurol. 2021 Feb 18;12:620852. doi: 10.3389/fneur.2021.620852. eCollection 2021.

  PMID: 33679586 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Where applicable, serum and plasma

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Annika Kruse, Dr.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annika Kruse, Dr.

CONTACT

00433163802329; annika.kruse@uni-graz.at

Martin Svehlik, Dr. med.

CONTACT

004331638514129; martin.svehlik@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 26, 2024
• Study Start: March 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Research data on which future papers are based will be made available shortly after publication.
• Access Criteria: Individual participant data (IPD) will be provided under the CC BY licence.

Locations

AU (1)