NCT05649930 Effect of Functional Power Training on Calf Muscle Length and Strength in Children With Spastic Paresis
| NCT ID | NCT05649930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | Cerebral Palsy, Spastic |
| Study Type | OBSERVATIONAL |
| Enrollment | 23 participants |
| Start Date | 2022-06-20 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 23 participants in total. It began in 2022-06-20 with a primary completion date of 2025-04-30.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Received (one of) the following interventions within six months: * Casting * Botulinum toxin type-A injections * Orthopedic surgery.
Contact & Investigator
Marjolein M van der Krogt, Dr.
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location VUmc
Frequently Asked Questions
Who can join the NCT05649930 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 18 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 NCT05649930 currently recruiting?
Yes, NCT05649930 is actively recruiting participants. Contact the research team at m.vanderkrogt@amsterdamumc.nl for enrollment information.
Where is the NCT05649930 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05649930 clinical trial?
NCT05649930 is sponsored by Amsterdam UMC, location VUmc. The principal investigator is Marjolein M van der Krogt, Dr. at Amsterdam UMC, location VUmc. The trial plans to enroll 23 participants.
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