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

Summary

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.

Conditions

• Cerebral Palsy, Spastic

Interventions

OTHER

MegaPower training

See arm/group descriptions

OTHER

Usual Care

See arm/group descriptions

Sponsors & Collaborators

• Netherlands Brain Foundation

  collaborator OTHER

• Koninklijk Nederlands Genootschap voor Fysiotherapie

  collaborator UNKNOWN

• De Phelps Stichting voor Spastici

  collaborator UNKNOWN

• Reade Rheumatology Research Institute

  collaborator OTHER

• Adelante, Centre of Expertise in Rehabilitation and Audiology

  collaborator OTHER

• Heliomare

  collaborator UNKNOWN

• Merem

  collaborator UNKNOWN

• Revant

  collaborator UNKNOWN

• Revalidatie Friesland

  collaborator UNKNOWN

• Roessingh

  collaborator UNKNOWN

• Treant Zorggroep

  collaborator UNKNOWN

• Johanna Kinderfonds

  collaborator UNKNOWN

• Amsterdam UMC, location VUmc

  lead OTHER

Principal Investigators

• Annemieke I. Buizer, prof. dr. · Amsterdam UMC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-19

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• Netherlands

Study Locations