Reade
Amsterdam, 1056 AB, Netherlands
Location status: Recruiting
NCT Number: NCT05649930
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.
Interested in participating?
Request Info4 year–18 year
All sexes
Observational
Amsterdam, 1056 AB, Netherlands
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The training consists of weighted running and walking exercises performed at high-velocity and is given three times a week for 12 weeks.
Time frame: 12 weeks before start training (week -12)
Time frame: At the start of training (week 0)
Time frame: At the end of the training (week 12)
Time frame: 12 weeks before start training (week -12)
Time frame: At the start of training (week 0)
Time frame: At the end of the training (week 12)
Time frame: 12 weeks before start training (week -12)
Time frame: At the start of training (week 0)
Time frame: At the end of the training (week 12)
Time frame: 12 weeks before start training (week -12)
Time frame: At the start of training (week 0)
Time frame: At the end of the training (week 12)
Time frame: At the start of training (week 0)
Measured with a hand-held dynamometer in Nm.
Time frame: At the end of the training (week 12)
Measured with a hand-held dynamometer in Nm.
Time frame: At the start of training (week 0)
Standing heel-rise test on one leg. Measured in amount of repetitions.
Time frame: At the end of the training (week 12)
Standing heel-rise test on one leg. Measured in amount of repetitions.
Time frame: At the start of training (week 0)
Measurement for lower and upper limb functionality.
Time frame: At the end of the training (week 12)
Measurement for lower and upper limb functionality.
Time frame: At the start of training (week 0)
Distance (m) covered in 1 min walking.
Time frame: At the end of the training (week 12)
Distance (m) covered in 1 min walking.
Time frame: At the start of training (week 0)
Measured in amount of steps reached.
Time frame: At the end of the training (week 12)
Measured in amount of steps reached.
Time frame: At the start of training (week 0)
Measured as average time (s) over 6x15 m sprint.
Time frame: At the end of the training (week 12)
Measured as average time (s) over 6x15 m sprint.
Time frame: At the start of training (week 0)
Maximal dorsiflexion in degrees manually measured with a goniometer.
Time frame: At the end of the training (week 12)
Maximal dorsiflexion in degrees manually measured with a goniometer.
Time frame: 12 weeks before start training (week -12)
Time frame: At the start of training (week 0)
Time frame: At the end of the training (week 12)
Time frame: 12 weeks before start training (week -12)
Time frame: At the start of training (week 0)
Time frame: At the end of the training (week 12)
Time frame: 12 weeks before start training (week -12)
Measured from the lateral malleolus and tibial plateau.
Time frame: At the start of training (week 0)
Measured from the lateral malleolus and tibial plateau.
Time frame: At the end of the training (week 12)
Measured from the lateral malleolus and tibial plateau.
Time frame: 12 weeks before start training (week -12)
Age, gender, GMFCS-level, medical history
Contact information is provided by the study sponsor or research team.
Amsterdam UMC, location VUmc
Other
Effect of Functional Power Training on Muscle Morphology and Strength of the Medial Gastrocnemius in Children With Spastic Paresis
Acronym: MegaMuscle
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07253857
Brain Damage, Chronic, Brain Diseases
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT06330922
Brain Damage, Chronic, Brain Diseases
Graz, Austria
View Trial DetailsNCT07118228
Brain Damage, Chronic, Brain Diseases
Kocaeli, Turkey (Türkiye)
View Trial DetailsNCT06640894
Brain Damage, Chronic, Brain Diseases
Emmen, Drenthe, Netherlands
View Trial Details