Muscle-tendon Pathology and Metabolic Dysregulation in CP

NCT ID: NCT06330922

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-08
• Study Completion Date: 2025-12-31

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.

Detailed Description

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.

Conditions

Cerebral Palsy, Spastic

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Cardiorespiratory fitness training

Intervention Type: 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.

Group 1: healthy individuals (cross-sectional study)

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

No interventions assigned to this group

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Frame Running

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annika Kruse, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Graz, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Annika Kruse, Dr.

Role: CONTACT

annika.kruse@uni-graz.at

00433163802329

Martin Svehlik, Dr. med.

Role: CONTACT

martin.svehlik@medunigraz.at

004331638514129

Facility Contacts

Sebastian Ruin, Univ.-Prof.

Role: primary

sebastian.ruin@uni-graz.at

00433163802336

References

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.

Reference Type: BACKGROUND

PMID: 12198474 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27188686 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16978459 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24708559 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26853808 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33679586 (View on PubMed)

Other Identifiers

10.55776/V992

Identifier Type: -

Identifier Source: org_study_id