Clinical trial NCT05649930: Effect of Functional Power Training on Calf Muscle Length and Strength in Children With Spastic Paresis
Official title: Effect of Functional Power Training on Muscle Morphology and Strength of the Medial Gastrocnemius in Children With Spastic Paresis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy, Spastic
Keywords: Medial gastrocnemius morphology
3D ultrasonography
Functional power training
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Reade Rheumatology Research Institute
name: University Ghent
First posted: 2022-12-14
Enrollment: 23
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The children will be recruited from rehabilitations centres in the Netherlands.

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.

Primary outcomes:
measure: Muscle volume in dm^3
timeFrame: 12 weeks before start training (week -12)
measure: Muscle volume in dm^3
timeFrame: At the start of training (week 0)
measure: Muscle volume in dm^3
timeFrame: At the end of the training (week 12)
measure: Muscle belly length in mm
timeFrame: 12 weeks before start training (week -12)
measure: Muscle belly length in mm
timeFrame: At the start of training (week 0)
measure: Muscle belly length in mm
timeFrame: At the end of the training (week 12)
measure: Tendon length in mm
timeFrame: 12 weeks before start training (week -12)
measure: Tendon length in mm
timeFrame: At the start of training (week 0)
measure: Tendon length in mm
timeFrame: At the end of the training (week 12)
measure: Fascicle length in mm
timeFrame: 12 weeks before start training (week -12)
measure: Fascicle length in mm
timeFrame: At the start of training (week 0)
measure: Fascicle length in mm
timeFrame: At the end of the training (week 12)
Secondary outcomes:
measure: Isometric muscle strength of the medial gastrocnemius
timeFrame: At the start of training (week 0)
measure: Isometric muscle strength of the medial gastrocnemius
timeFrame: At the end of the training (week 12)
measure: Dynamic muscle strength
timeFrame: At the start of training (week 0)
measure: Dynamic muscle strength
timeFrame: At the end of the training (week 12)
measure: Functional Strength Measure (FSM)
timeFrame: At the start of training (week 0)
measure: Functional Strength Measure (FSM)
timeFrame: At the end of the training (week 12)
measure: 1-minute-walk-test
timeFrame: At the start of training (week 0)
measure: 1-minute-walk-test
timeFrame: At the end of the training (week 12)
measure: 10m Shuttle run test
timeFrame: At the start of training (week 0)
measure: 10m Shuttle run test
timeFrame: At the end of the training (week 12)
measure: 6x15m sprint
timeFrame: At the start of training (week 0)
measure: 6x15m sprint
timeFrame: At the end of the training (week 12)
measure: Ankle range of motion
timeFrame: At the start of training (week 0)
measure: Ankle range of motion
timeFrame: At the end of the training (week 12)
measure: Body weight in kg
timeFrame: 12 weeks before start training (week -12)
measure: Body weight in kg
timeFrame: At the start of training (week 0)
measure: Body weight in kg
timeFrame: At the end of the training (week 12)
measure: Body length in m
timeFrame: 12 weeks before start training (week -12)
measure: Body length in m
timeFrame: At the start of training (week 0)
measure: Body length in m
timeFrame: At the end of the training (week 12)
measure: Lower leg length in mm
timeFrame: 12 weeks before start training (week -12)
measure: Lower leg length in mm
timeFrame: At the start of training (week 0)
measure: Lower leg length in mm
timeFrame: At the end of the training (week 12)
Other outcomes:
measure: Medical file information
timeFrame: 12 weeks before start training (week -12)
Locations:
city: Amsterdam
country: Netherlands
facility: Reade
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Marjolein M van der Krogt, Dr.
role: PRINCIPAL_INVESTIGATOR
References: