NCT06640894 Power2Walk: The Impact of Functional Power Training on Participation and Activity in Children With Cerebral Palsy.
| NCT ID | NCT06640894 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | Cerebral Palsy, Spastic |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2024-07-19 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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).
Contact & Investigator
Annemieke I. Buizer, prof. dr.
PRINCIPAL INVESTIGATOR
Amsterdam UMC
Frequently Asked Questions
Who can join the NCT06640894 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Cerebral Palsy, Spastic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06640894 currently recruiting?
Yes, NCT06640894 is actively recruiting participants. Contact the research team at r.dersjant@amsterdamumc.nl for enrollment information.
Where is the NCT06640894 trial being conducted?
This trial is being conducted at Emmen, Netherlands, Almere Stad, Netherlands, Valkenburg, Netherlands, Breda, Netherlands and 6 additional locations.
Who is sponsoring the NCT06640894 clinical trial?
NCT06640894 is sponsored by Amsterdam UMC, location VUmc. The principal investigator is Annemieke I. Buizer, prof. dr. at Amsterdam UMC. The trial plans to enroll 66 participants.
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