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

NCT05649930 | Recruiting

• 4 other identifiers: MegaMuscle202101520210088AMS-2021-Innovatiecall-P5
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Keywords

Medial gastrocnemius morphology; 3D ultrasonography; Functional power training

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (23)

• Isometric muscle strength of the medial gastrocnemius

  At the start of training (week 0)

• Isometric muscle strength of the medial gastrocnemius

  At the end of the training (week 12)

• Dynamic muscle strength

  At the start of training (week 0)

• Dynamic muscle strength

  At the end of the training (week 12)

• Functional Strength Measure (FSM)

  At the start of training (week 0)

Other Outcomes (1)

• Medical file information

  12 weeks before start training (week -12)

Study Arms (1)

Spastic paresis

Children with spastic paresis

Other: Functional power training

Interventions

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.

Spastic paresis

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Received (one of) the following interventions within six months:
• Casting
• Botulinum toxin type-A injections
• Orthopedic surgery.

Sponsors & Collaborators

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

Study Sites (1)

Reade

Amsterdam, 1056 AB, Netherlands

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Marjolein M van der Krogt, Dr.

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjolein M van der Krogt, Dr.

CONTACT

(20)4440789; m.vanderkrogt@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: December 14, 2022
• Study Start: June 20, 2022
• Primary Completion: April 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)