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

Effect of Functional Power Training on Muscle Morphology and Strength of the Medial Gastrocnemius 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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Other: Functional power training

• Study Type: Observational
• Enrollment (Estimated): 23

Contacts and Locations

• Study Contact: Name: Marjolein M van der Krogt, Dr.; Phone Number: +31 (20)4440789; Email: m.vanderkrogt@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1056 AB
    • Recruiting
    • Reade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The children will be recruited from rehabilitations centres in the Netherlands.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Muscle volume in dm^3	12 weeks before start training (week -12)
Muscle volume in dm^3	At the start of training (week 0)
Muscle volume in dm^3	At the end of the training (week 12)
Muscle belly length in mm	12 weeks before start training (week -12)
Muscle belly length in mm	At the start of training (week 0)
Muscle belly length in mm	At the end of the training (week 12)
Tendon length in mm	12 weeks before start training (week -12)
Tendon length in mm	At the start of training (week 0)
Tendon length in mm	At the end of the training (week 12)
Fascicle length in mm	12 weeks before start training (week -12)
Fascicle length in mm	At the start of training (week 0)
Fascicle length in mm	At the end of the training (week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric muscle strength of the medial gastrocnemius	Measured with a hand-held dynamometer in Nm.	At the start of training (week 0)
Isometric muscle strength of the medial gastrocnemius	Measured with a hand-held dynamometer in Nm.	At the end of the training (week 12)
Dynamic muscle strength	Standing heel-rise test on one leg. Measured in amount of repetitions.	At the start of training (week 0)
Dynamic muscle strength	Standing heel-rise test on one leg. Measured in amount of repetitions.	At the end of the training (week 12)
Functional Strength Measure (FSM)	Measurement for lower and upper limb functionality.	At the start of training (week 0)
Functional Strength Measure (FSM)	Measurement for lower and upper limb functionality.	At the end of the training (week 12)
1-minute-walk-test	Distance (m) covered in 1 min walking.	At the start of training (week 0)
1-minute-walk-test	Distance (m) covered in 1 min walking.	At the end of the training (week 12)
10m Shuttle run test	Measured in amount of steps reached.	At the start of training (week 0)
10m Shuttle run test	Measured in amount of steps reached.	At the end of the training (week 12)
6x15m sprint	Measured as average time (s) over 6x15 m sprint.	At the start of training (week 0)
6x15m sprint	Measured as average time (s) over 6x15 m sprint.	At the end of the training (week 12)
Ankle range of motion	Maximal dorsiflexion in degrees manually measured with a goniometer.	At the start of training (week 0)
Ankle range of motion	Maximal dorsiflexion in degrees manually measured with a goniometer.	At the end of the training (week 12)
Body weight in kg		12 weeks before start training (week -12)
Body weight in kg		At the start of training (week 0)
Body weight in kg		At the end of the training (week 12)
Body length in m		12 weeks before start training (week -12)
Body length in m		At the start of training (week 0)
Body length in m		At the end of the training (week 12)
Lower leg length in mm	Measured from the lateral malleolus and tibial plateau.	12 weeks before start training (week -12)
Lower leg length in mm	Measured from the lateral malleolus and tibial plateau.	At the start of training (week 0)
Lower leg length in mm	Measured from the lateral malleolus and tibial plateau.	At the end of the training (week 12)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical file information	Age, gender, GMFCS-level, medical history	12 weeks before start training (week -12)

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: University Ghent; Reade Rheumatology Research Institute
• Investigators: Principal Investigator: Marjolein M van der Krogt, Dr., Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: 3D ultrasonography; Medial gastrocnemius morphology; Functional power training
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Damage, Chronic; Muscle Spasticity; Cerebral Palsy; Paresis
• Other Study ID Numbers: MegaMuscle; 20210088 (Other Grant/Funding Number: JKF/KFA); 2021015 (Other Grant/Funding Number: Phelps stichting voor spastici); AMS-2021-Innovatiecall-P5 (Other Grant/Funding Number: Amsterdam Movement Sciences)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No