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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05649930
Other study ID # MegaMuscle
Secondary ID 202101520210088A
Status Recruiting
Phase
First received
Last updated
Start date June 20, 2022
Est. completion date September 2025

Study information

Verified date November 2022
Source Amsterdam UMC, location VUmc
Contact Marjolein M van der Krogt, Dr.
Phone (20)4440789
Email m.vanderkrogt@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 23
Est. completion date September 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Netherlands Reade Amsterdam

Sponsors (3)

Lead Sponsor Collaborator
Amsterdam UMC, location VUmc Reade Rheumatology Research Institute, University Ghent

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Medical file information Age, gender, GMFCS-level, medical history 12 weeks before start training (week -12)
Primary Muscle volume in dm^3 12 weeks before start training (week -12)
Primary Muscle volume in dm^3 At the start of training (week 0)
Primary Muscle volume in dm^3 At the end of the training (week 12)
Primary Muscle belly length in mm 12 weeks before start training (week -12)
Primary Muscle belly length in mm At the start of training (week 0)
Primary Muscle belly length in mm At the end of the training (week 12)
Primary Tendon length in mm 12 weeks before start training (week -12)
Primary Tendon length in mm At the start of training (week 0)
Primary Tendon length in mm At the end of the training (week 12)
Primary Fascicle length in mm 12 weeks before start training (week -12)
Primary Fascicle length in mm At the start of training (week 0)
Primary Fascicle length in mm At the end of the training (week 12)
Secondary Isometric muscle strength of the medial gastrocnemius Measured with a hand-held dynamometer in Nm. At the start of training (week 0)
Secondary Isometric muscle strength of the medial gastrocnemius Measured with a hand-held dynamometer in Nm. At the end of the training (week 12)
Secondary Dynamic muscle strength Standing heel-rise test on one leg. Measured in amount of repetitions. At the start of training (week 0)
Secondary Dynamic muscle strength Standing heel-rise test on one leg. Measured in amount of repetitions. At the end of the training (week 12)
Secondary Functional Strength Measure (FSM) Measurement for lower and upper limb functionality. At the start of training (week 0)
Secondary Functional Strength Measure (FSM) Measurement for lower and upper limb functionality. At the end of the training (week 12)
Secondary 1-minute-walk-test Distance (m) covered in 1 min walking. At the start of training (week 0)
Secondary 1-minute-walk-test Distance (m) covered in 1 min walking. At the end of the training (week 12)
Secondary 10m Shuttle run test Measured in amount of steps reached. At the start of training (week 0)
Secondary 10m Shuttle run test Measured in amount of steps reached. At the end of the training (week 12)
Secondary 6x15m sprint Measured as average time (s) over 6x15 m sprint. At the start of training (week 0)
Secondary 6x15m sprint Measured as average time (s) over 6x15 m sprint. At the end of the training (week 12)
Secondary Ankle range of motion Maximal dorsiflexion in degrees manually measured with a goniometer. At the start of training (week 0)
Secondary Ankle range of motion Maximal dorsiflexion in degrees manually measured with a goniometer. At the end of the training (week 12)
Secondary Body weight in kg 12 weeks before start training (week -12)
Secondary Body weight in kg At the start of training (week 0)
Secondary Body weight in kg At the end of the training (week 12)
Secondary Body length in m 12 weeks before start training (week -12)
Secondary Body length in m At the start of training (week 0)
Secondary Body length in m At the end of the training (week 12)
Secondary Lower leg length in mm Measured from the lateral malleolus and tibial plateau. 12 weeks before start training (week -12)
Secondary Lower leg length in mm Measured from the lateral malleolus and tibial plateau. At the start of training (week 0)
Secondary Lower leg length in mm Measured from the lateral malleolus and tibial plateau. At the end of the training (week 12)
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