Power2Walk: The Impact of Functional Power Training on Participation and Activity in Children With Cerebral Palsy.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorAmsterdam UMC, location VUmc

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • MegaPower training
  • Usual Care

Treatment groups

66 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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