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NCT Number: NCT05649930

Effect of Functional Power Training on Calf Muscle Length and Strength 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.

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Reade

Amsterdam, 1056 AB, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional Power Training

Other

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

Primary outcomes

  1. Muscle volume in dm^3

    Time frame: 12 weeks before start training (week -12)

  2. Muscle volume in dm^3

    Time frame: At the start of training (week 0)

  3. Muscle volume in dm^3

    Time frame: At the end of the training (week 12)

  4. Muscle belly length in mm

    Time frame: 12 weeks before start training (week -12)

  5. Muscle belly length in mm

    Time frame: At the start of training (week 0)

  6. Muscle belly length in mm

    Time frame: At the end of the training (week 12)

  7. Tendon length in mm

    Time frame: 12 weeks before start training (week -12)

  8. Tendon length in mm

    Time frame: At the start of training (week 0)

  9. Tendon length in mm

    Time frame: At the end of the training (week 12)

  10. Fascicle length in mm

    Time frame: 12 weeks before start training (week -12)

  11. Fascicle length in mm

    Time frame: At the start of training (week 0)

  12. Fascicle length in mm

    Time frame: At the end of the training (week 12)

Secondary outcomes

  1. Isometric muscle strength of the medial gastrocnemius

    Time frame: At the start of training (week 0)

    Measured with a hand-held dynamometer in Nm.

  2. Isometric muscle strength of the medial gastrocnemius

    Time frame: At the end of the training (week 12)

    Measured with a hand-held dynamometer in Nm.

  3. Dynamic muscle strength

    Time frame: At the start of training (week 0)

    Standing heel-rise test on one leg. Measured in amount of repetitions.

  4. Dynamic muscle strength

    Time frame: At the end of the training (week 12)

    Standing heel-rise test on one leg. Measured in amount of repetitions.

  5. Functional Strength Measure (FSM)

    Time frame: At the start of training (week 0)

    Measurement for lower and upper limb functionality.

  6. Functional Strength Measure (FSM)

    Time frame: At the end of the training (week 12)

    Measurement for lower and upper limb functionality.

  7. 1-minute-walk-test

    Time frame: At the start of training (week 0)

    Distance (m) covered in 1 min walking.

  8. 1-minute-walk-test

    Time frame: At the end of the training (week 12)

    Distance (m) covered in 1 min walking.

  9. 10m Shuttle run test

    Time frame: At the start of training (week 0)

    Measured in amount of steps reached.

  10. 10m Shuttle run test

    Time frame: At the end of the training (week 12)

    Measured in amount of steps reached.

  11. 6x15m sprint

    Time frame: At the start of training (week 0)

    Measured as average time (s) over 6x15 m sprint.

  12. 6x15m sprint

    Time frame: At the end of the training (week 12)

    Measured as average time (s) over 6x15 m sprint.

  13. Ankle range of motion

    Time frame: At the start of training (week 0)

    Maximal dorsiflexion in degrees manually measured with a goniometer.

  14. Ankle range of motion

    Time frame: At the end of the training (week 12)

    Maximal dorsiflexion in degrees manually measured with a goniometer.

  15. Body weight in kg

    Time frame: 12 weeks before start training (week -12)

  16. Body weight in kg

    Time frame: At the start of training (week 0)

  17. Body weight in kg

    Time frame: At the end of the training (week 12)

  18. Body length in m

    Time frame: 12 weeks before start training (week -12)

  19. Body length in m

    Time frame: At the start of training (week 0)

  20. Body length in m

    Time frame: At the end of the training (week 12)

  21. Lower leg length in mm

    Time frame: 12 weeks before start training (week -12)

    Measured from the lateral malleolus and tibial plateau.

  22. Lower leg length in mm

    Time frame: At the start of training (week 0)

    Measured from the lateral malleolus and tibial plateau.

  23. Lower leg length in mm

    Time frame: At the end of the training (week 12)

    Measured from the lateral malleolus and tibial plateau.

Other outcomes

  1. Medical file information

    Time frame: 12 weeks before start training (week -12)

    Age, gender, GMFCS-level, medical history

Study contacts

Contact information is provided by the study sponsor or research team.

Marjolein M van der Krogt, Dr.

CONTACT

[email protected]

(20)4440789 ext. +31

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Reade Rheumatology Research Institute
  • University Ghent

Registry information

Official study title

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

Acronym: MegaMuscle

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 14, 2022
Registry last updated
Jan 8, 2025

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.

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