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

NCT06640894 | Recruiting DMC

• 2 other identifiers: NL85905.018.232024.0022
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 10

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.

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral palsy

Outcome Measures

Primary Outcomes (1)

• Goal Attainment (Goal Attainment Scaling)

  Goal Attainment Scaling (GAS) is a method used to measure the achievement of individual goals in a structured and quantitative manner. It is commonly used in clinical and educational settings to evaluate progress and outcomes. Each goal is scaled on a six-point scale, ranging from -3 to +2: Goal Attainment Scaling endpoints will be formulated according to SMART-principles to standardize results.

  Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

Secondary Outcomes (21)

• Mobility Questionnaire 28 (MobQues28)

  Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

• Gait Outcomes Assessment List (GOAL)

  Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

• Harter's Self-Perception Profile for Children

  Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.

• Physical activity (accelerometer)

  Baseline (t = 0 weeks); t = 12 weeks

• Sleep (accelerometer)

  Baseline (t = 0 weeks); t = 12 weeks

Study Arms (2)

Intervention (MegaPower training)

EXPERIMENTAL

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.

Other: MegaPower training

Control (Usual Care)

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

MegaPower training OTHER

See arm/group descriptions

Intervention (MegaPower training)

Usual Care OTHER

See arm/group descriptions

Control (Usual Care)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Koninklijk Nederlands Genootschap voor Fysiotherapie: collaborator
• De Phelps Stichting voor Spastici: collaborator
• Reade Rheumatology Research Institute: collaborator
• Adelante, Centre of Expertise in Rehabilitation and Audiology: collaborator
• Heliomare: collaborator
• Merem: collaborator
• Revant: collaborator
• Revalidatie Friesland: collaborator
• Roessingh: collaborator
• Treant Zorggroep: collaborator
• Johanna Kinderfonds: collaborator
• Amsterdam UMC, location VUmc: lead
• Netherlands Brain Foundation: collaborator

Study Sites (10)

Treant Zorggroep

Emmen, Drenthe, Netherlands

RECRUITING

Merem

Almere Stad, Flevoland, Netherlands

RECRUITING

Adelante zorggroep

Valkenburg, Limburg, Netherlands

RECRUITING

Revant

Breda, North Brabant, Netherlands

NOT YET RECRUITING

Reade

Amsterdam, North Holland, Netherlands

RECRUITING

Heliomare

Heemskerk, North Holland, Netherlands

RECRUITING

Merem

Hilversum, North Holland, Netherlands

RECRUITING

Roessingh

Enschede, Overijssel, Netherlands

RECRUITING

Revalidatie Friesland

Beetsterzwaag, Provincie Friesland, 9244CL, Netherlands

RECRUITING

Revant

Goes, Zeeland, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Annemieke I. Buizer, prof. dr.

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rijk Dersjant, drs.

CONTACT

+31 20 4440761; r.dersjant@amsterdamumc.nl

Marjolein M. Van der Krogt, dr.

CONTACT

+31 20 4440789; m.vanderkrogt@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator

Model Details: A single-blind randomized controlled parallel trial with a 24 week follow-up.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: October 15, 2024
• Study Start: July 19, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (10)