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Recruiting NCT05649930

Effect of Functional Power Training on Calf Muscle Length and Strength in Children With Spastic Paresis

— Observational Cerebral Palsy, Spastic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Functional power training.
Who it may be relevant to
Registry conditions: Cerebral Palsy, Spastic. Basic parameters: 4 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Functional Power Training on Muscle Morphology and Strength of the Medial Gastrocnemius in Children With Spastic Paresis

Overview

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.

Interventions

  • Other Functional power training
    The training consists of weighted running and walking exercises performed at high-velocity and is given three times a week for 12 weeks.

Primary outcome measures

  • 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)]
Secondary outcome measures (12)
  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Reade — Amsterdam

Identifiers

NCT: NCT05649930 · MegaMuscle · 2021015 · 20210088 · AMS-2021-Innovatiecall-P5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗