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Clinical Trials/NCT05649930
NCT05649930
Recruiting
Not Applicable

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

Amsterdam UMC, location VUmc1 site in 1 country23 target enrollmentJune 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy, Spastic
Sponsor
Amsterdam UMC, location VUmc
Enrollment
23
Locations
1
Primary Endpoint
Tendon length in mm
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 20, 2022
End Date
September 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Amsterdam UMC, location VUmc
Responsible Party
Principal Investigator
Principal Investigator

Babette Mooijekind

Coordinating Investigator

Amsterdam UMC, location VUmc

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:
  • Botulinum toxin type-A injections
  • Orthopedic surgery.

Outcomes

Primary Outcomes

Tendon length in mm

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

Muscle belly length in mm

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

Muscle volume in dm^3

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

Fascicle length in mm

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

Secondary Outcomes

  • Isometric muscle strength of the medial gastrocnemius(At the end of the training (week 12))
  • 10m Shuttle run test(At the end of the training (week 12))
  • Lower leg length in mm(At the end of the training (week 12))
  • Dynamic muscle strength(At the end of the training (week 12))
  • Ankle range of motion(At the end of the training (week 12))
  • Body length in m(At the end of the training (week 12))
  • 1-minute-walk-test(At the end of the training (week 12))
  • 6x15m sprint(At the end of the training (week 12))
  • Body weight in kg(At the end of the training (week 12))
  • Functional Strength Measure (FSM)(At the end of the training (week 12))

Study Sites (1)

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