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

NCT ID: NCT06640894

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-19
• Study Completion Date: 2027-08-31

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.

Detailed Description

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 that may result in spasticity, dyskinesia, or ataxia. Due to these motor impairments, children with CP struggle to keep up with typically developing peers when participating in physical and/or social activities. Yet, participation is a key factor in child development, mainly because it is instrumental in enhancing mental well-being through building friendships, developing a personal identity, optimizing physical growth, and increasing motor control. Earlier studies concluded that children with CP are indeed at an elevated risk for reduced physical activity and participation. Consequently, the development of these children may be hampered. Therefore, targeted interventions that increase physical activity and participation are essential for supporting the general development of children with CP. A large number of treatments have been developed for children with CP, ranging from pharmacological agents that manage tone to invasive surgical interventions. Whilst many of these treatments effectively improve motor control, very few address the underlying fatigue that is typically seen in these children, which causes a vicious cycle of reduced physical fitness, early onset of fatigue, and decreased physical activity levels. This decline in physical fitness is ultimately detrimental to participation, and therefore a wide variety of exercise-related treatment options are being explored to improve motor control, physical fitness, and participation.

Recently, functional power training (FPT) emerged as a potentially successful supplementary treatment method to improve participation in children with CP. This type of strength training combines high velocity movements with progressive resistance to mimic and train the demands of playing activities like playground running and sprinting in games and sports. Indeed, a previous double-baseline study indicated that FPT improves physical fitness, muscle strength, activity, and participation in ambulatory children with CP. This is unlike progressive resistance training (PRT), which increases muscle strength but not walking ability, anaerobic capacity, and ultimately participation. This discrepancy is likely explained by the functional nature of FPT, which specifically trains activities of daily living and not only muscle strength. Moreover, power training may be more effective than strength training as power training incorporates high intensity, explosive-like contractions that are required in daily living situations. Consequently, FPT is more effective than PRT in improving walking ability, thereby better supporting participation in ambulatory children with CP. Nevertheless, high-level scientific evidence underpinning the efficacy of FPT on walking ability, aerobic endurance, anaerobic capacity, and participation in ambulant children with CP is still lacking. Furthermore, it remains unclear what predictive factors best identify which children with CP benefit most from FPT. Additionally, it remains unknown whether the potential benefits of FPT on walking ability, aerobic endurance, anaerobic capacity, and participation in children with CP are maintained when FPT is discontinued.

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention (MegaPower training)

MegaPower training is a twelve-week long functional power training program in which children will perform functional power training three times a week together with a personal trainer. During the intervention, training volume will be influenced by training weight, velocity of movement, and amount of repetitions. The training program has the following characteristics:

1. (Weighted) functional exercises like walking, running, and walking stairs.

2. High velocity movements.

3. Progressive overload.

Prior to and during the training, a physiotherapist makes a personalized participation plan for the child. This plan is used to tackle participation barriers related to their goal (not directly related to mobility; e.g. beliefs or behaviours) encountered by the child (e.g. involving parents, a sports consultant, a psychologist).

Both at twelve and twenty-four weeks during the follow-up, parent and child will visit again to measure whether the effects on participation are long-lasting.

Group Type: EXPERIMENTAL

MegaPower training

Intervention Type: OTHER

See arm/group descriptions

Control (Usual Care)

The control group will receive their usual care for twelve weeks (non-intervention group). This usual care consists of physiotherapy appointments, for example.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

See arm/group descriptions

Interventions

MegaPower training

See arm/group descriptions

Intervention Type: OTHER

Usual Care

See arm/group descriptions

Intervention Type: OTHER

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).

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Netherlands Brain Foundation

OTHER

Sponsor Role: collaborator

Koninklijk Nederlands Genootschap voor Fysiotherapie

UNKNOWN

Sponsor Role: collaborator

De Phelps Stichting voor Spastici

UNKNOWN

Sponsor Role: collaborator

Reade Rheumatology Research Institute

OTHER

Sponsor Role: collaborator

Adelante, Centre of Expertise in Rehabilitation and Audiology

OTHER

Sponsor Role: collaborator

Heliomare

UNKNOWN

Sponsor Role: collaborator

Merem

UNKNOWN

Sponsor Role: collaborator

Revant

UNKNOWN

Sponsor Role: collaborator

Revalidatie Friesland

UNKNOWN

Sponsor Role: collaborator

Roessingh

UNKNOWN

Sponsor Role: collaborator

Treant Zorggroep

UNKNOWN

Sponsor Role: collaborator

Johanna Kinderfonds

UNKNOWN

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Rijk Dersjant

Coordinating investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annemieke I. Buizer, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

Treant Zorggroep

Emmen, Drenthe, Netherlands

Site Status: RECRUITING

Merem

Almere Stad, Flevoland, Netherlands

Site Status: RECRUITING

Adelante zorggroep

Valkenburg, Limburg, Netherlands

Site Status: RECRUITING

Revant

Breda, North Brabant, Netherlands

Site Status: NOT_YET_RECRUITING

Reade

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Heliomare

Heemskerk, North Holland, Netherlands

Site Status: RECRUITING

Merem

Hilversum, North Holland, Netherlands

Site Status: RECRUITING

Roessingh

Enschede, Overijssel, Netherlands

Site Status: RECRUITING

Revalidatie Friesland

Beetsterzwaag, Provincie Friesland, Netherlands

Site Status: RECRUITING

Revant

Goes, Zeeland, Netherlands

Site Status: NOT_YET_RECRUITING

Countries

Netherlands

Central Contacts

Rijk Dersjant, drs.

Role: CONTACT

Phone: +31 20 4440761

Email: r.dersjant@amsterdamumc.nl

Marjolein M. Van der Krogt, dr.

Role: CONTACT

Phone: +31 20 4440789

Email: m.vanderkrogt@amsterdamumc.nl

Facility Contacts

Marije Koning

Role: primary

Elise Hooft, drs.

Role: primary

Eugene A. Rameckers, dr.

Role: primary

Jens van Helleman

Role: primary

Liesbeth F. Van Vulpen, dr.

Role: primary

Jette E. Van Egmond, drs.

Role: primary

Elise Hooft, drs.

Role: primary

Marc Nederhand, dr.

Role: primary

Heleen Reinders-Messelink, dr.

Role: primary

Jens van Helleman

Role: primary

Other Identifiers

2024.0022

Identifier Type: OTHER

Identifier Source: secondary_id

NL85905.018.23

Identifier Type: -

Identifier Source: org_study_id