Rationale: Children with cerebral palsy (CP) experience limitations in walking ability due to functional motor impairments caused by neurodevelopmental damage during fetal or early child development. Due to these motor impairments, children with CP struggle to keep up with typically developing peers when participating in physical and/or social activities. Consequently, the development of these children may be hampered. Recently, functional power training (FPT) emerged as a potentially successful supplementary treatment method to improve participation in children with CP. It is understood that FPT is more effective than progressive resistance training in improving walking ability and endurance, and thereby better supports participation in ambulatory children with CP. Nevertheless, high-level scientific evidence underpinning the efficacy of FPT on these parameters in ambulant children with CP is still lacking. The investigators hypothesize that FPT effectively helps accomplish patient-tailored participation and activity goals in ambulant children with CP.
Objective: This study aims to investigate whether twelve weeks of FPT (MegaPower training) effectively accomplish patient-tailored participation and activity goals in ambulant children with CP, when compared to their usual care. Additionally, the goal is to investigate i) whether MegaPower training improves walking ability, aerobic endurance, and anaerobic capacity; ii) what factors best identify which ambulant children with CP benefit most from twelve weeks of MegaPower training; iii) to what extend the MegaPower training was implemented as intended in the participating study centers?, and iv) whether the effects of the MegaPower training are maintained after 12 and 24 weeks of follow-up.
Study design: A single-blind randomized controlled parallel trial with a 24 week follow-up. During the follow-up, the control group will also receive MegaPower training.
Study population: Ambulant children with cerebral palsy or a related non-progressive disorder between the ages of 4 - 12.
Intervention: One group will receive twelve weeks of FPT (MegaPower training), whilst the other group will receive twelve weeks of usual care (control group).
Main study parameters/endpoints: Accomplishment of patient-tailored participation and activity goals, measured through Goal Attainment Scaling.
Children with cerebral palsy or a related non-progressive disorder between the ages of 4 to 12.
Gross Motor Function Classification System (GMFCS) level I - III.
Parents and/or children have a treatment question related to participation of the child.
Participants that suffer from a progressive neurological disorder.
Treatment with botulinum toxin and/or serial casting in lower extremities planned during the study period.
Treatment with botulinum toxin in the twelve weeks prior to participation in the study.
Treatment with serial casting in the three weeks prior to participation in the study.
Parallel
MegaPower training
Other interventionSee arm/group descriptions
Usual Care
Other interventionSee arm/group descriptions
Goal Attainment (Goal Attainment Scaling)
Goal Attainment Scaling (GAS) is a method used to measure the achievement of individual goals in a structured and quantitative manner. It is commonly used in clinical and educational settings to evaluate progress and outcomes. Each goal is scaled on a six-point scale, ranging from -3 to +2: Goal Attainment Scaling endpoints will be formulated according to SMART-principles to standardize results.
Mobility Questionnaire 28 (MobQues28)
The MobQues28 is a parent-reported mobility questionnaire used in cerebral palsy research that assesses gait-related function across different domains of the International Classification of Functioning, Disability and Health (ICF) developed for ambulant children with CP.
Gait Outcomes Assessment List (GOAL)
The GOAL is a parent-reported mobility questionnaire that assesses gait-related function across different domains of the ICF and is developed for ambulant children with CP. The GOAL is a more comprehensive and better standardized version of the MobQues28. However, since our study population is based off expected differences in the MobQues28 (since data for the GOAL on this subject does not exist yet), both questionnaires are included.
Harter's Self-Perception Profile for Children
Harter's Self-Perception Profile for Children (HSPPC) is a psychological assessment tool designed to measure self-concept in children. Children will be assessed on the domains of social competence, athletic competence, and global self-worth.
Physical activity (accelerometer)
Physical activity will be measured over a 7-day period using a wearable accelerometer that participants will have to carry for seven days. The accelerometer picks up accelerations of the body and can accurately estimate physical (in)activity accordingly. The accelerometer does not have an interface and does not save any personal data.
Click on the lead sponsor to view all of their trials.
Amsterdam UMC, location VUmc
Lead sponsor
VU University of Amsterdam
Sponsor institution
Netherlands Brain Foundation
Collaborator
Koninklijk Nederlands Genootschap voor Fysiotherapie
Collaborator
De Phelps Stichting voor Spastici
Collaborator
Reade Rheumatology Research Institute
Collaborator
Adelante, Centre of Expertise in Rehabilitation and Audiology
Collaborator
Heliomare
Collaborator
Merem
Collaborator
Revant
Collaborator
Revalidatie Friesland
Collaborator
Roessingh
Collaborator
Treant Zorggroep
Collaborator
Johanna Kinderfonds
Collaborator
