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

Sponsor
Amsterdam UMC, location VUmc (Other)
Overall Status
Recruiting
CT.gov ID
NCT05649930
Collaborator
Reade Rheumatology Research Institute (Other), University Ghent (Other)
23
1
38.4
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Functional power training

Study Design

Study Type:
Observational
Anticipated Enrollment :
23 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Functional Power Training on Muscle Morphology and Strength of the Medial Gastrocnemius in Children With Spastic Paresis
Actual Study Start Date :
Jun 20, 2022
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Spastic paresis

Children with spastic paresis

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.

Outcome Measures

Primary Outcome Measures

  1. Muscle volume in dm^3 [12 weeks before start training (week -12)]

  2. Muscle volume in dm^3 [At the start of training (week 0)]

  3. Muscle volume in dm^3 [At the end of the training (week 12)]

  4. Muscle belly length in mm [12 weeks before start training (week -12)]

  5. Muscle belly length in mm [At the start of training (week 0)]

  6. Muscle belly length in mm [At the end of the training (week 12)]

  7. Tendon length in mm [12 weeks before start training (week -12)]

  8. Tendon length in mm [At the start of training (week 0)]

  9. Tendon length in mm [At the end of the training (week 12)]

  10. Fascicle length in mm [12 weeks before start training (week -12)]

  11. Fascicle length in mm [At the start of training (week 0)]

  12. Fascicle length in mm [At the end of the training (week 12)]

Secondary Outcome Measures

  1. Isometric muscle strength of the medial gastrocnemius [At the start of training (week 0)]

    Measured with a hand-held dynamometer in Nm.

  2. Isometric muscle strength of the medial gastrocnemius [At the end of the training (week 12)]

    Measured with a hand-held dynamometer in Nm.

  3. Dynamic muscle strength [At the start of training (week 0)]

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

  4. Dynamic muscle strength [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) [At the start of training (week 0)]

    Measurement for lower and upper limb functionality.

  6. Functional Strength Measure (FSM) [At the end of the training (week 12)]

    Measurement for lower and upper limb functionality.

  7. 1-minute-walk-test [At the start of training (week 0)]

    Distance (m) covered in 1 min walking.

  8. 1-minute-walk-test [At the end of the training (week 12)]

    Distance (m) covered in 1 min walking.

  9. 10m Shuttle run test [At the start of training (week 0)]

    Measured in amount of steps reached.

  10. 10m Shuttle run test [At the end of the training (week 12)]

    Measured in amount of steps reached.

  11. 6x15m sprint [At the start of training (week 0)]

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

  12. 6x15m sprint [At the end of the training (week 12)]

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

  13. Ankle range of motion [At the start of training (week 0)]

    Maximal dorsiflexion in degrees manually measured with a goniometer.

  14. Ankle range of motion [At the end of the training (week 12)]

    Maximal dorsiflexion in degrees manually measured with a goniometer.

  15. Body weight in kg [12 weeks before start training (week -12)]

  16. Body weight in kg [At the start of training (week 0)]

  17. Body weight in kg [At the end of the training (week 12)]

  18. Body length in m [12 weeks before start training (week -12)]

  19. Body length in m [At the start of training (week 0)]

  20. Body length in m [At the end of the training (week 12)]

  21. Lower leg length in mm [12 weeks before start training (week -12)]

    Measured from the lateral malleolus and tibial plateau.

  22. Lower leg length in mm [At the start of training (week 0)]

    Measured from the lateral malleolus and tibial plateau.

  23. Lower leg length in mm [At the end of the training (week 12)]

    Measured from the lateral malleolus and tibial plateau.

Other Outcome Measures

  1. Medical file information [12 weeks before start training (week -12)]

    Age, gender, GMFCS-level, medical history

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Reade Amsterdam Netherlands 1056 AB

Sponsors and Collaborators

  • Amsterdam UMC, location VUmc
  • Reade Rheumatology Research Institute
  • University Ghent

Investigators

  • Principal Investigator: Marjolein M van der Krogt, Dr., Amsterdam UMC, location VUmc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Babette Mooijekind, Principal Investigator, Amsterdam UMC, location VUmc
ClinicalTrials.gov Identifier:
NCT05649930
Other Study ID Numbers:
  • MegaMuscle
  • 2021015
  • 20210088
  • AMS-2021-Innovatiecall-P5
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Babette Mooijekind, Principal Investigator, Amsterdam UMC, location VUmc
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2022