Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
Cerebral Palsy
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 8 years and 15 years
Gender
Both males and females

Description

Cerebral palsy (CP) is a condition that describes a group of disorders (altered muscle tone, movements disorder, muscle weakness, ataxia and rigidity) covering the development of movement and posture causing activity limitations and reduced quality of life (1). In Denmark 2000-2500 children and adol...

Cerebral palsy (CP) is a condition that describes a group of disorders (altered muscle tone, movements disorder, muscle weakness, ataxia and rigidity) covering the development of movement and posture causing activity limitations and reduced quality of life (1). In Denmark 2000-2500 children and adolescents under the age of 18 are living with the diagnosis of cerebral palsy. This is equivalent to two children being diagnosed with cerebral palsy per 1000 living births (2). Though, CP is a non-progressive diagnosis, it is a lifelong condition that requires attention through most of the patient's life, as impairments that inhibit performance of activities and participation in daily living develops (1, 3). Children and adolescents with cerebral palsy are a vulnerable group who find it challenging to meet the physical activity guidelines, therefore predisposing them to the negative health implications associated with low levels of physical activity and high levels of sedentary time (4). Although there are no specific evidence-based physical activity guidelines for children and adolescents with cerebral palsy, it is clear that they have lower levels of physical activity than their peers, that they do not meet the World Health Organization's physical activity guidelines, and that their level of mobility limitation is negatively associated with their level of physical activity (5, 6). Therefore, the objective of this study is to investigate predictors of physical activity and inactivity in children and adolescents with cerebral palsy with the perspective of providing evidence-based motivators for optimized physical activity, with the potential benefit of improved overall health and quality of life. This is a prospective clinical cohort study. Eligible children and adolescents and their families will be identified through the Danish Health Data Authority after which the parents/guardians will receive written information about the study through digital post, e-Boks. Parents/guardians will be asked to fill out questionnaires on quality of life, overall health, pain and participation in normal daily activities, and the children/adolescents will be asked to wear accelerometers for seven consecutive days. Data from the Cerebral Palsy FollowUp Program (CPUP) register will be collected. Gait analysis will be performed on a sub-group of children, i.e. those who are referred to three-dimensional gait analyses as a part of their individualized clinical treatment plan. A subgroup of families will be invited to participate in interviews. All collected data will be compared with data from former studies of Danish children based on the same methodological framework. The comparison enables analyses of how, and to what extent, cerebral palsy affects the included children's and adolescents' physical activity behavior and quality of life. The project will be implemented in accordance with the Helsinki Declaration II. It has been approved by the Danish Data protection Agency and has been declared not notifiable by the Regional Committee on Health Research Ethics, cf. Committee Act Art. 14, paragraph 1 (S-20192000-23). All subject data will be treated confidentially and in confidence under the Danish laws on personal data and health. This study will provide novel evidence that will improve the knowledge on how to optimize physical activity, and thus improve overall health and quality of life, for the current group of children and adolescents. Due to wide inclusion criteria, this knowledge will constitute a high level of generalizability and most probably high acceptance by the treating health professionals as the majority of variables of interest already are implemented in a current cerebral palsy registry. Finally, the findings may be implemented in evidence-based physical activity guidelines, which currently are lacking for the present group of children and adolescents with cerebral palsy. Koman LA, Smith BP, Shilt JS. Cerebral palsy. Lancet (London, England). 2004;363(9421):1619-31. Frøslev-Friis C, Dunkhase-Heinl U, Andersen JD, Stausbøl-Grøn B, Hansen AV, Garne E. Epidemiology of cerebral palsy in Southern Denmark. Danish medical journal. 2015;62(1):A4990. Bell KJ, Ounpuu S, DeLuca PA, Romness MJ. Natural progression of gait in children with cerebral palsy. J Pediatr Orthop. 2002;22(5):677-82. Organization WHO. Global recommendations for physical activity for health. Switzerland2010. Carlon SL, Taylor NF, Dodd KJ, Shields N. Differences in habitual physical activity levels of young people with cerebral palsy and their typically developing peers: a systematic review. Disability and rehabilitation. 2013;35(8):647-55. Bjornson KF, Belza B, Kartin D, Logsdon R, McLaughlin JF. Ambulatory physical activity performance in youth with cerebral palsy and youth who are developing typically. Phys Ther. 2007;87(3):248-57.

Tracking Information

NCT #
NCT04614207
Collaborators
  • Elsass Foundation
  • Region of Southern Denmark
  • AJ Andersen og Hustrus Fond
  • Familien Hede Nielsens Fond
  • Dagmar Marshalls Fond
  • Fonden til Lægevidenskabens Fremme
Investigators
Study Director: Anders Holsgaard-Larsen, Assoc. Prof Department of Clinical Research, University of Southern Denmark. Principal Investigator: Christina E Fonvig, MSc Department of Clinical Research, University of Southern Denmark.