Cerebral Palsy, SpasticPower2WalkNCT06640894
Power2Walk: The Impact of Functional Power Training on Participation and Activity in Children With Cerebral Palsy.
A study testing MegaPower training in people with Cerebral Palsy, Spastic, run by Amsterdam UMC, location VUmc at 10 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- MegaPower training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 10 sitesNetherlands
- Study dates
- 19 Jul 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Netherlands10 sites, 10 recruiting
- Recruiting
Merem
Almere Stad, Flevoland
Elise Hooft, drs., ehooft@merem.nl
Elise Hooft, drs.
- Recruiting
Reade
Amsterdam, North Holland
Liesbeth F. Van Vulpen, dr., l.v.vulpen@reade.nl
Liesbeth F. Van Vulpen, dr.
- Recruiting
Revalidatie Friesland
Beetsterzwaag, Provincie Friesland, 9244CL
Heleen Reinders-Messelink, dr., +31 88 5801580, h.reinders-messelink@revalidatie-friesland.nl
Fokke Fennema
- Not yet recruiting
Revant
Breda, North Brabant
Jens van Helleman, +31 88 735 8000, j.vanhelleman@revant.nl
Jens van Helleman
- Recruiting
Treant Zorggroep
Emmen, Drenthe
Marije Koning, +31 88 129 29 29, m.a.koning@treant.nl
- Recruiting
Roessingh
Enschede, Overijssel
Marc Nederhand, dr., +31 53 487 5875, m.nederhand@rrd.nl
Jolienke Colenbrander
- Not yet recruiting
Revant
Goes, Zeeland
Jens van Helleman, +31 88 735 8000, j.vanhelleman@revant.nl
Jens van Helleman
- Recruiting
Heliomare
Heemskerk, North Holland
Jette E. Van Egmond, drs., je.van.egmond@heliomare.nl
Jette E. Van Egmond, drs.
- Recruiting
Merem
Hilversum, North Holland
Elise Hooft, drs., ehooft@merem.nl
Jeffrey van Limpt
- Recruiting
Adelante zorggroep
Valkenburg, Limburg
Eugene A. Rameckers, dr., eaa.rameckers@hetnet.nl
Eugene A. Rameckers, dr.
About this study
Official title: Power2Walk: The Impact of Functional Power Training on Participation and Activity in Children With Cerebral Palsy - A Randomized Controlled Trial
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.
Read more
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.
Read the 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
- Being tested
- MegaPower training, Usual Care
- Keywords
- Cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MegaPower trainingOther
See arm/group descriptions
Usual CareOther
See arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Secondary outcomes (21)
Mobility Questionnaire 28 (MobQues28)
The MobQues28 is a parent-reported mobility questionnaire used in cerebral palsy research that assesses gait-related function across different domains of the International Classification of Functioning, Disability and Health (ICF) developed for ambulant children with CP.
Measured: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Gait Outcomes Assessment List (GOAL)
The GOAL is a parent-reported mobility questionnaire that assesses gait-related function across different domains of the ICF and is developed for ambulant children with CP. The GOAL is a more comprehensive and better standardized version of the MobQues28. However, since our study population is based off expected differences in the MobQues28 (since data for the GOAL on this subject does not exist yet), both questionnaires are included.
Measured: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Harter's Self-Perception Profile for Children
Harter's Self-Perception Profile for Children (HSPPC) is a psychological assessment tool designed to measure self-concept in children. Children will be assessed on the domains of social competence, athletic competence, and global self-worth.
Measured: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Physical activity (accelerometer)
Physical activity will be measured over a 7-day period using a wearable accelerometer that participants will have to carry for seven days. The accelerometer picks up accelerations of the body and can accurately estimate physical (in)activity accordingly. The accelerometer does not have an interface and does not save any personal data.
Measured: Baseline (t = 0 weeks); t = 12 weeks
Sleep (accelerometer)
Sleep will be measured over a 7-day period using a wearable accelerometer that participants will have to carry for seven days. The accelerometer picks up accelerations of the body and can estimate sleep duration and quality. The accelerometer does not have an interface and does not save any personal data.
Measured: Baseline (t = 0 weeks); t = 12 weeks
Body composition (bioelectrical impedance analysis)
Body composition; measured using bioelectrical impedance analysis (BIA). BIA is a method to assess body composition based on the resistance of different tissue types against an unnoticeable electric pulse through the body, since fat mass and fat free mass have a different conductivity.
Measured: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Walking speed (1-minute walk test)
The 1-minute walk test is a physical test that measures walking speed. The child is asked to walk as quickly as possible around a measured track for a period of one minute. The distance walked within 1 minute is measured and recorded.
Measured: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Aerobic endurance (shuttle run test)
The shuttle run test is a physical test that measures aerobic endurance. Children walk or run at a set incremental speed between two markers that are placed ten meters apart. These walks/runs are coordinated by a recorded CD that plays a sound at pre-determined intervals. Children have to keep up with the speed of these intervals and are measured by the level they reached. Different validated tests will be used for children of different GMFCS levels.
Measured: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Anaerobic capacity (muscle power sprint test).
The Muscle Power Sprint Test is a physical test that measures anaerobic capacity. Children have to perform a fifteen meter sprint as fast as possible, repeated six times with ten seconds of rest in between. Their score will be presented in mean and peak power (force * speed).
Measured: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Dietary intake (3-day food record)
Dietary intake at baseline; measured using a 3-day food record in which parents have to track the nutritional intake of their child during two week days and one weekend day.
Measured: Baseline (t = 0 weeks).
Process evaluation
A process evaluation will be employed to monitor and document program implementation. With this information, the goal is to evaluate to what extend the MegaPower training was implemented as intended in the participating study centers. This allows us to understand the relationship between specific program elements and program outcomes. The framework by Saunders et al., describing five components of process evaluation will be used. The methods proposed contains questionnaires, report and registration forms, interviews, and focus groups. As a part of this process evaluation, parents will also be asked to fill out a questionnaire about whether their child is happy with the care they received.
Measured: Through study completion. An average of 2 years.
Age
Age (years and months) at start of study.
Measured: Baseline (t = 0 weeks)
Height (cm)
Measured: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Weight (kg)
Measured: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Gender (male/female/other)
Measured: Baseline (t = 0 weeks)
GMFCS level (I, II, or III)
The mobility and gross motor skills of people with cerebral palsy are categorized into five different levels using a tool called the Gross Motor Function Classification System (GMFCS).
Measured: Baseline (t = 0 weeks)
Type of cerebral palsy
Spastic/dyskinetic/ataxic/unilateral/bilateral/hemiplegia/diplegia/quadriplegia/other.
Measured: Baseline (t = 0 weeks)
Type of education (regular/special)
Measured: Baseline (t = 0 weeks)
Education level of parent(s)
Measured: Baseline (t = 0 weeks)
Use of ankle-foot orthoses (yes/no)
Measured: Baseline (t = 0 weeks)
Participation in sports
Do the child and the family of the child participate in any sports? And if so, how many times a week?
Measured: Baseline (t = 0 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start19 Jul 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind randomized controlled parallel trial with a 24 week follow-up.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Brain Foundation, Koninklijk Nederlands Genootschap voor Fysiotherapie, De Phelps Stichting voor Spastici, Reade Rheumatology Research Institute, Adelante, Centre of Expertise in Rehabilitation and Audiology, Heliomare, Merem, Revant, Revalidatie Friesland, Roessingh, Treant Zorggroep, Johanna Kinderfonds
- Responsible party
- Principal investigator, Rijk Dersjant, VU University of Amsterdam
- Investigators
- Annemieke I. Buizer, prof. dr., Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640894
- Sponsor's protocol ID
- NL85905.018.23
- Other IDs
- 2024.0022
- Acronym
- Power2Walk
- Status last verified
- Dec 2025
- First submitted
- 19 Aug 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power2Walk: The Impact of Functional Power Training on Participation and Activity in Children With Cerebral Palsy - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06640894
- Acronym / sponsor ID
- Power2Walk / NL85905.018.23
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Cerebral palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Netherlands Brain Foundation, Koninklijk Nederlands Genootschap voor Fysiotherapie, De Phelps Stichting voor Spastici, Reade Rheumatology Research Institute, Adelante, Centre of Expertise in Rehabilitation and Audiology, Heliomare, Merem, Revant, Revalidatie Friesland, Roessingh, Treant Zorggroep, Johanna Kinderfonds
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A single-blind randomized controlled parallel trial with a 24 week follow-up.
| Arm | Type | Receives |
|---|---|---|
| Intervention (MegaPower training) | Experimental | Other: MegaPower trainingMegaPower 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. |
| Control (Usual Care) | Active comparator | Other: Usual CareThe control group will receive their usual care for twelve weeks (non-intervention group). This usual care consists of physiotherapy appointments, for example. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MegaPower trainingSee arm/group descriptions | Other | Intervention (MegaPower training) |
| Usual CareSee arm/group descriptions | Other | Control (Usual Care) |
Primary outcome
Goal Attainment (Goal Attainment Scaling)
Time frame: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
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.
21 secondary outcomes
Mobility Questionnaire 28 (MobQues28)
Time frame: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Gait Outcomes Assessment List (GOAL)
Time frame: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Harter's Self-Perception Profile for Children
Time frame: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Physical activity (accelerometer)
Time frame: Baseline (t = 0 weeks); t = 12 weeks
Sleep (accelerometer)
Time frame: Baseline (t = 0 weeks); t = 12 weeks
Body composition (bioelectrical impedance analysis)
Time frame: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Walking speed (1-minute walk test)
Time frame: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Aerobic endurance (shuttle run test)
Time frame: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Anaerobic capacity (muscle power sprint test).
Time frame: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Dietary intake (3-day food record)
Time frame: Baseline (t = 0 weeks).
Process evaluation
Time frame: Through study completion. An average of 2 years.
Age
Time frame: Baseline (t = 0 weeks)
Height (cm)
Time frame: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Weight (kg)
Time frame: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.
Gender (male/female/other)
Time frame: Baseline (t = 0 weeks)
GMFCS level (I, II, or III)
Time frame: Baseline (t = 0 weeks)
Type of cerebral palsy
Time frame: Baseline (t = 0 weeks)
Type of education (regular/special)
Time frame: Baseline (t = 0 weeks)
Education level of parent(s)
Time frame: Baseline (t = 0 weeks)
Use of ankle-foot orthoses (yes/no)
Time frame: Baseline (t = 0 weeks)
Participation in sports
Time frame: Baseline (t = 0 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annemieke I. Buizer, prof. dr. principal investigator
Amsterdam UMC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MegaPower training in people with Cerebral Palsy, Spastic, run by Amsterdam UMC, location VUmc at 10 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rijk Dersjant, drs. (+31 20 4440761, r.dersjant@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment (Goal Attainment Scaling) (time frame: Baseline (t = 0 weeks); t = 12 weeks, t = 24 weeks, t = 36 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.