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

NCT ID: NCT05649930

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-20

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy, Spastic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spastic paresis

Children with spastic paresis

Functional power training

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reade Rheumatology Research Institute

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Babette Mooijekind

Coordinating Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marjolein M van der Krogt, Dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

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Reade

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Marjolein M van der Krogt, Dr.

Role: CONTACT

(20)4440789 ext. +31

Other Identifiers

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2021015

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20210088

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AMS-2021-Innovatiecall-P5

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MegaMuscle

Identifier Type: -

Identifier Source: org_study_id

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