Cerebral Palsy, Spastic Clinical Trial
— MegaMuscleOfficial 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.
Status | Recruiting |
Enrollment | 23 |
Est. completion date | September 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Reade | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Amsterdam UMC, location VUmc | Reade Rheumatology Research Institute, University Ghent |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Medical file information | Age, gender, GMFCS-level, medical history | 12 weeks before start training (week -12) | |
Primary | Muscle volume in dm^3 | 12 weeks before start training (week -12) | ||
Primary | Muscle volume in dm^3 | At the start of training (week 0) | ||
Primary | Muscle volume in dm^3 | At the end of the training (week 12) | ||
Primary | Muscle belly length in mm | 12 weeks before start training (week -12) | ||
Primary | Muscle belly length in mm | At the start of training (week 0) | ||
Primary | Muscle belly length in mm | At the end of the training (week 12) | ||
Primary | Tendon length in mm | 12 weeks before start training (week -12) | ||
Primary | Tendon length in mm | At the start of training (week 0) | ||
Primary | Tendon length in mm | At the end of the training (week 12) | ||
Primary | Fascicle length in mm | 12 weeks before start training (week -12) | ||
Primary | Fascicle length in mm | At the start of training (week 0) | ||
Primary | Fascicle length in mm | At the end of the training (week 12) | ||
Secondary | Isometric muscle strength of the medial gastrocnemius | Measured with a hand-held dynamometer in Nm. | At the start of training (week 0) | |
Secondary | Isometric muscle strength of the medial gastrocnemius | Measured with a hand-held dynamometer in Nm. | At the end of the training (week 12) | |
Secondary | Dynamic muscle strength | Standing heel-rise test on one leg. Measured in amount of repetitions. | At the start of training (week 0) | |
Secondary | Dynamic muscle strength | Standing heel-rise test on one leg. Measured in amount of repetitions. | At the end of the training (week 12) | |
Secondary | Functional Strength Measure (FSM) | Measurement for lower and upper limb functionality. | At the start of training (week 0) | |
Secondary | Functional Strength Measure (FSM) | Measurement for lower and upper limb functionality. | At the end of the training (week 12) | |
Secondary | 1-minute-walk-test | Distance (m) covered in 1 min walking. | At the start of training (week 0) | |
Secondary | 1-minute-walk-test | Distance (m) covered in 1 min walking. | At the end of the training (week 12) | |
Secondary | 10m Shuttle run test | Measured in amount of steps reached. | At the start of training (week 0) | |
Secondary | 10m Shuttle run test | Measured in amount of steps reached. | At the end of the training (week 12) | |
Secondary | 6x15m sprint | Measured as average time (s) over 6x15 m sprint. | At the start of training (week 0) | |
Secondary | 6x15m sprint | Measured as average time (s) over 6x15 m sprint. | At the end of the training (week 12) | |
Secondary | Ankle range of motion | Maximal dorsiflexion in degrees manually measured with a goniometer. | At the start of training (week 0) | |
Secondary | Ankle range of motion | Maximal dorsiflexion in degrees manually measured with a goniometer. | At the end of the training (week 12) | |
Secondary | Body weight in kg | 12 weeks before start training (week -12) | ||
Secondary | Body weight in kg | At the start of training (week 0) | ||
Secondary | Body weight in kg | At the end of the training (week 12) | ||
Secondary | Body length in m | 12 weeks before start training (week -12) | ||
Secondary | Body length in m | At the start of training (week 0) | ||
Secondary | Body length in m | At the end of the training (week 12) | ||
Secondary | Lower leg length in mm | Measured from the lateral malleolus and tibial plateau. | 12 weeks before start training (week -12) | |
Secondary | Lower leg length in mm | Measured from the lateral malleolus and tibial plateau. | At the start of training (week 0) | |
Secondary | Lower leg length in mm | Measured from the lateral malleolus and tibial plateau. | At the end of the training (week 12) |
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