Cerebral Palsy, SpasticMegaMuscleNCT05649930
Effect of Functional Power Training on Calf Muscle Length and Strength in Children With Spastic Paresis
An observational study of Cerebral Palsy, Spastic, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Spastic paresis (SP) is a common motor condition in children and is often caused by cerebral palsy. Skeletal muscles develop differently in children with SP due to brain damage in early development; muscle strength and muscle length are reduced compared to typically developing (TD) children. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Functional power training
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Jun 2022to 30 Sep 2025
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The children will be recruited from rehabilitations centres in the Netherlands.
Who may be able to join
- Gross Motor Function Classification System I-III
- Children should be able to lie on their stomach for min. one minute
- Children should be able to follow instructions.
Who cannot join
- Received (one of) the following interventions within six months:
- Casting
- Botulinum toxin type-A injections
- Orthopedic surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Functional Power Training on Muscle Morphology and Strength of the Medial Gastrocnemius in Children With Spastic Paresis
Spastic paresis (SP) is a common motor condition in children and is often caused by cerebral palsy. Skeletal muscles develop differently in children with SP due to brain damage in early development; muscle strength and muscle length are reduced compared to typically developing (TD) children. Especially, the calf muscles are affected, which particularly affects their ability to walk and to run, hindering participation in society. There are several treatments aimed to increase the range of motion of the joint by lengthening the muscle, for example botulinum toxin injections. However, these treatments can have a weakening effect on the muscle due to deconditioning from immobilization and due to paralysis.
In rehabilitation centers in the Netherlands functional power training (MegaPower) is offered to children with SP who want to walk and run better. It has been shown that this training improves calf muscle strength and performance during functional walking tests. However, the effect of MegaPower training on muscle morphology (i.a. muscle volume and length) is still unknown. Therefore, the aim of this study is to assess the effect of MegaPower training on the muscle morphology of the medial gastrocnemius in children with SP using 3D ultrasonography. It is expected that MegaPower training results in an increase of muscle volume as well as elongation of the muscle belly. Muscle volume could increase due to hypertrophy of the muscle fibers induced by the training, which could elongate the muscle belly length due to the pennate structure of the medial gastrocnemius. A double-baseline design will be applied for this study with three different measurement times (T0-T1-T2) to compare the training period (12 weeks) with a period (12 weeks) of usual care.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Functional power training
- Keywords
- Medial gastrocnemius morphology, 3D ultrasonography, Functional power training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional power trainingOther
The training consists of weighted running and walking exercises performed at high-velocity and is given three times a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Spastic paresis | Children with spastic paresis Receives: Other: Functional power training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle volume in dm^3
Measured: 12 weeks before start training (week -12)
Muscle volume in dm^3
Measured: At the start of training (week 0)
Muscle volume in dm^3
Measured: At the end of the training (week 12)
Muscle belly length in mm
Measured: 12 weeks before start training (week -12)
Muscle belly length in mm
Measured: At the start of training (week 0)
Muscle belly length in mm
Measured: At the end of the training (week 12)
Tendon length in mm
Measured: 12 weeks before start training (week -12)
Tendon length in mm
Measured: At the start of training (week 0)
Tendon length in mm
Measured: At the end of the training (week 12)
Fascicle length in mm
Measured: 12 weeks before start training (week -12)
Fascicle length in mm
Measured: At the start of training (week 0)
Fascicle length in mm
Measured: At the end of the training (week 12)
Secondary outcomes (23)
Isometric muscle strength of the medial gastrocnemius
Measured with a hand-held dynamometer in Nm.
Measured: At the start of training (week 0)
Isometric muscle strength of the medial gastrocnemius
Measured with a hand-held dynamometer in Nm.
Measured: At the end of the training (week 12)
Dynamic muscle strength
Standing heel-rise test on one leg. Measured in amount of repetitions.
Measured: At the start of training (week 0)
Dynamic muscle strength
Standing heel-rise test on one leg. Measured in amount of repetitions.
Measured: At the end of the training (week 12)
Functional Strength Measure (FSM)
Measurement for lower and upper limb functionality.
Measured: At the start of training (week 0)
Functional Strength Measure (FSM)
Measurement for lower and upper limb functionality.
Measured: At the end of the training (week 12)
1-minute-walk-test
Distance (m) covered in 1 min walking.
Measured: At the start of training (week 0)
1-minute-walk-test
Distance (m) covered in 1 min walking.
Measured: At the end of the training (week 12)
10m Shuttle run test
Measured in amount of steps reached.
Measured: At the start of training (week 0)
10m Shuttle run test
Measured in amount of steps reached.
Measured: At the end of the training (week 12)
6x15m sprint
Measured as average time (s) over 6x15 m sprint.
Measured: At the start of training (week 0)
6x15m sprint
Measured as average time (s) over 6x15 m sprint.
Measured: At the end of the training (week 12)
Ankle range of motion
Maximal dorsiflexion in degrees manually measured with a goniometer.
Measured: At the start of training (week 0)
Ankle range of motion
Maximal dorsiflexion in degrees manually measured with a goniometer.
Measured: At the end of the training (week 12)
Body weight in kg
Measured: 12 weeks before start training (week -12)
Body weight in kg
Measured: At the start of training (week 0)
Body weight in kg
Measured: At the end of the training (week 12)
Body length in m
Measured: 12 weeks before start training (week -12)
Body length in m
Measured: At the start of training (week 0)
Body length in m
Measured: At the end of the training (week 12)
Lower leg length in mm
Measured from the lateral malleolus and tibial plateau.
Measured: 12 weeks before start training (week -12)
Lower leg length in mm
Measured from the lateral malleolus and tibial plateau.
Measured: At the start of training (week 0)
Lower leg length in mm
Measured from the lateral malleolus and tibial plateau.
Measured: At the end of the training (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start20 Jun 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Sep 2025 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Reade Rheumatology Research Institute, University Ghent
- Responsible party
- Principal investigator, Babette Mooijekind, Amsterdam UMC, location VUmc
- Investigators
- Marjolein M van der Krogt, Dr., Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649930
- Sponsor's protocol ID
- MegaMuscle
- Other IDs
- 2021015, 20210088, AMS-2021-Innovatiecall-P5
- Acronym
- MegaMuscle
- Status last verified
- Jan 2025
- First submitted
- 7 Nov 2022
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Power Training on Muscle Morphology and Strength of the Medial Gastrocnemius in Children With Spastic Paresis
- ClinicalTrials.gov ID
- NCT05649930
- Acronym / sponsor ID
- MegaMuscle / MegaMuscle
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Medial gastrocnemius morphology, 3D ultrasonography, Functional power training
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Reade Rheumatology Research Institute, University Ghent
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 14 Dec 2022 (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.
Spastic paresis (SP) is a common motor condition in children and is often caused by cerebral palsy. Skeletal muscles develop differently in children with SP due to brain damage in early development; muscle strength and muscle length are reduced compared to typically developing (TD) children. Especially, the calf muscles are affected, which particularly affects their ability to walk and to run, hindering participation in society. There are several treatments aimed to increase the range of motion of the joint by lengthening the muscle, for example botulinum toxin injections. However, these treatments can have a weakening effect on the muscle due to deconditioning from immobilization and due to paralysis.
In rehabilitation centers in the Netherlands functional power training (MegaPower) is offered to children with SP who want to walk and run better. It has been shown that this training improves calf muscle strength and performance during functional walking tests. However, the effect of MegaPower training on muscle morphology (i.a. muscle volume and length) is still unknown. Therefore, the aim of this study is to assess the effect of MegaPower training on the muscle morphology of the medial gastrocnemius in children with SP using 3D ultrasonography. It is expected that MegaPower training results in an increase of muscle volume as well as elongation of the muscle belly. Muscle volume could increase due to hypertrophy of the muscle fibers induced by the training, which could elongate the muscle belly length due to the pennate structure of the medial gastrocnemius. A double-baseline design will be applied for this study with three different measurement times (T0-T1-T2) to compare the training period (12 weeks) with a period (12 weeks) of usual care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spastic paresis | – | Other: Functional power trainingChildren with spastic paresis |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The children will be recruited from rehabilitations centres in the Netherlands.
Key inclusion criteria (3 listed)
- Gross Motor Function Classification System I-III
- Children should be able to lie on their stomach for min. one minute
- Children should be able to follow instructions.
Key exclusion criteria (4 listed)
- Received (one of) the following interventions within six months:
- Casting
- Botulinum toxin type-A injections
- Orthopedic surgery.
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 |
|---|---|---|
| Functional power trainingThe training consists of weighted running and walking exercises performed at high-velocity and is given three times a week for 12 weeks. | Other | Spastic paresis |
Primary outcome
Muscle volume in dm^3
Time frame: 12 weeks before start training (week -12)
Muscle volume in dm^3
Time frame: At the start of training (week 0)
Muscle volume in dm^3
Time frame: At the end of the training (week 12)
Muscle belly length in mm
Time frame: 12 weeks before start training (week -12)
Muscle belly length in mm
Time frame: At the start of training (week 0)
Muscle belly length in mm
Time frame: At the end of the training (week 12)
Tendon length in mm
Time frame: 12 weeks before start training (week -12)
Tendon length in mm
Time frame: At the start of training (week 0)
Tendon length in mm
Time frame: At the end of the training (week 12)
Fascicle length in mm
Time frame: 12 weeks before start training (week -12)
Fascicle length in mm
Time frame: At the start of training (week 0)
Fascicle length in mm
Time frame: At the end of the training (week 12)
23 secondary outcomes
Isometric muscle strength of the medial gastrocnemius
Time frame: At the start of training (week 0)
Isometric muscle strength of the medial gastrocnemius
Time frame: At the end of the training (week 12)
Dynamic muscle strength
Time frame: At the start of training (week 0)
Dynamic muscle strength
Time frame: At the end of the training (week 12)
Functional Strength Measure (FSM)
Time frame: At the start of training (week 0)
Functional Strength Measure (FSM)
Time frame: At the end of the training (week 12)
1-minute-walk-test
Time frame: At the start of training (week 0)
1-minute-walk-test
Time frame: At the end of the training (week 12)
10m Shuttle run test
Time frame: At the start of training (week 0)
10m Shuttle run test
Time frame: At the end of the training (week 12)
6x15m sprint
Time frame: At the start of training (week 0)
6x15m sprint
Time frame: At the end of the training (week 12)
Ankle range of motion
Time frame: At the start of training (week 0)
Ankle range of motion
Time frame: At the end of the training (week 12)
Body weight in kg
Time frame: 12 weeks before start training (week -12)
Body weight in kg
Time frame: At the start of training (week 0)
Body weight in kg
Time frame: At the end of the training (week 12)
Body length in m
Time frame: 12 weeks before start training (week -12)
Body length in m
Time frame: At the start of training (week 0)
Body length in m
Time frame: At the end of the training (week 12)
Lower leg length in mm
Time frame: 12 weeks before start training (week -12)
Lower leg length in mm
Time frame: At the start of training (week 0)
Lower leg length in mm
Time frame: At the end of the training (week 12)
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 8 Jan 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.
Marjolein M van der Krogt, Dr. principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, Spastic, run by Amsterdam UMC, location VUmc at 1 site 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 4 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 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Marjolein M van der Krogt, Dr. ((20)4440789 ext. +31, m.vanderkrogt@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle volume in dm^3 (time frame: 12 weeks before start training (week -12)). The study lists 12 primary outcomes in all. 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 8 Jan 2025.