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

Study acronym: Power2Walk
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study sites: 9 to 10
    • Collaborators: 11 to 12
    v3
  2. Minor Study sites: 5 to 9
    • Collaborators: 7 to 11
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06640894
Lead Sponsor Amsterdam UMC, location VUmc
Collaborators: Netherlands Brain Foundation, Koninklijk Nederlands Genootschap voor Fysiotherapie, De Phelps Stichting voor Spastici, Reade Rheumatology Research Institute, Adelante, Centre of Expertise in Rehabilitation and Audiology, Heliomare, Merem, Revant, Revalidatie Friesland, Roessingh, Treant Zorggroep, Johanna Kinderfonds
Conditions
(from sponsor)
Cerebral Palsy, Spastic
Related terms Cerebral Palsy
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov