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临床试验/NCT03124628
NCT03124628撤回不适用

Effects of Flywheel Resistance Exercise Training on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy

Karolinska Institutet2 个研究点 分布在 1 个国家开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Electromyography of lower limb muscles

研究概览

简要总结

The main purpose of this project is to improve physical function and muscle health in teenagers and young adults with cerebral palsy (CP) by using an eccentric-overload resistance exercise model

Specific aims

  1. To compare the efficacy of eccentric-overload vs. weight stack resistance exercise in inducing muscle, functional and gait performance adaptations in teenagers with CP.
  2. To increase force, power and muscle mass in the lower limbs of patients with cerebral palsy.
  3. To improve gross motor function, balance and gait through eccentric-overload resistance exercise in teenagers suffering from cerebral palsy.

We hypothesize that the time-effective flywheel resistance exercise paradigm will result in greater gains in muscle mass and function in teenagers with CP, when compared with conventional weight-stack technology. Importantly, we believe these adaptations will be translated into enhanced gross motor function, balance and gait performance.

Forty teenagers and young adults (age range 16-23 yr) with spastic CP will be recruited. They will be randomly assigned to flywheel (FL; n=20) or weight-stack (WS; n=20) resistance exercise. During 8 weeks, all the teenagers will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients will perform either flywheel (FL group) or conventional (WS group) leg press resistance exercise twice per week. Muscle force, power and activity (electromyography; EMG), leg extension lag, co-contraction, balance, functional mobility, gait quality, and muscle and fat thickness of lower extremities are assessed in all patients before and after the 8-week intervention (Fig. 1).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Teenagers and young adults between 16-25 years of age
  • Unilateral or bilateral spastic cerebral palsy
  • Gross Motor Function Classification System (GMFCS) of level I, II or III.
  • Exclusion Criteria
  • Surgical treatments of the knee extensor apparatus within the last 12 months
  • Botulinum toxin treatment within the last six months
  • Ongoing intrathecal baclofen treatment

排除标准

  • 未提供

结局指标

主要结局

Electromyography of lower limb muscles

时间窗: Change from pre- to post-intervention (8 wks)

Muscle activation (mV) will be assessed in lower limb muscles (i.e. vastus lateralis, biceps femoris, gluteus medius, medial gastrocnemius) using surface electromyography techniques

Assessment of activities of daily living

时间窗: Change from pre- to post-intervention (8 wks)

Assessment of activities of daily living is measured using the Timed Up-and-Go test, the Chair-stand and the 6-min walking test.

Gait performance adaptations to training including muscle activation and co-contraction during walking

时间窗: Change from pre- to post-intervention (8 wks)

Gait performance will be analyzed using an 8-camera 3-D kinematic VICON system and force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital. Overall gait pathology will also be assessed using the multivariate Gait Deviation Index. Muscle activation and co-contraction during gait will be assessed using wireless surface electromyography

Gross motor function

时间窗: Change from pre- to post-intervention (8 wks)

Gross motor function will be assessed using Gross Motor Function Measure (GMFM)

Balance

时间窗: Change from pre- to post-intervention (8 wks)

Static and dynamic balance is assessed using force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital

Muscle performance

时间窗: Change from pre- to post-intervention (8 wks)

Unilateral maximal voluntary isometric force is measured in both legs with force sensors. Similarly, unilateral (both legs) concentric and eccentric peak power is assessed through an encoder system. Furthermore, dynamic force during concentric and eccentric actions is measured via force sensors.

Muscle architecture

时间窗: Change from pre- to post-intervention (8 wks)

Vastus lateralis muscle thickness, together with fascicle pennation angle and muscle echogenicity, will be assessed using ultrasound technique in both legs. Thigh circumference will be assessed using measurement tape.

Muscle spasticity

时间窗: Change from pre- to post-intervention (8 wks)

Spasticity will be assessed using the Ashworth scale

次要结局

  • Subcutaneous fat thickness(Change from pre- to post-intervention (8 wks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo Fernandez Gonzalo

PhD

Karolinska Institutet

研究点 (2)

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