RecruitingNot ApplicableNCT06640894

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

Power2Walk: The Impact of Functional Power Training on Participation and Activity in Children With Cerebral Palsy - A Randomized Controlled Trial


Sponsor

Amsterdam UMC, location VUmc

Enrollment

66 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 4 YearsMax Age: 12 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria8

  • 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.
  • Children that underwent a selective dorsal rhizotomy twelve months prior to participation in the study.
  • Children that underwent orthopedic surgery on their lower extremities in the 12 months before participation in the study.
  • Children that have received MegaPower training in the last 4 months before participation in the study.
  • Children for whom walking is not their preferred method of locomotion (yet).

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERMegaPower training

See arm/group descriptions

OTHERUsual Care

See arm/group descriptions


Locations(10)

Treant Zorggroep

Emmen, Drenthe, Netherlands

Merem

Almere Stad, Flevoland, Netherlands

Adelante zorggroep

Valkenburg, Limburg, Netherlands

Revant

Breda, North Brabant, Netherlands

Reade

Amsterdam, North Holland, Netherlands

Heliomare

Heemskerk, North Holland, Netherlands

Merem

Hilversum, North Holland, Netherlands

Roessingh

Enschede, Overijssel, Netherlands

Revalidatie Friesland

Beetsterzwaag, Provincie Friesland, Netherlands

Revant

Goes, Zeeland, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06640894


Related Trials