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临床试验/NCT05649930
NCT05649930招募中不适用

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

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2022年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
23
试验地点
1
主要终点
Tendon length in mm

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Tendon length in mm

时间窗: At the end of the training (week 12)

Muscle belly length in mm

时间窗: At the end of the training (week 12)

Muscle volume in dm^3

时间窗: At the end of the training (week 12)

Fascicle length in mm

时间窗: At the end of the training (week 12)

次要结局

  • 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))

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Babette Mooijekind

Coordinating Investigator

Amsterdam UMC, location VUmc

研究点 (1)

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