跳至主要内容
临床试验/NCT04570358
NCT04570358已完成不适用

Stretching in Children With Spastic Cerebral Palsy

University of Graz2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Change in spasticity/stretch hyperreflexia

研究概览

简要总结

The primary aim of this study is to gain knowledge about both the effects of a single bout of static and proprioceptive neuromuscular facilitation (PNF) stretching and the effects of 8-week static and PNF stretching training on the calf muscle-tendon properties in children with spastic cerebral palsy (SCP). Furthermore, the effects on joint and muscle function, stretch reflexes, gait, and self-reported gait function and functional performance are examined to receive a comprehensive picture of potential changes.

Further aims of this study are to identify which stretching technique might be more efficient by comparing the effects of both stretching interventions, and to gain information about the influence of foot flexibility on the stretch achieved by the spastic gastrocnemius muscle.

详细描述

Background: Spastic cerebral palsy (SCP) is a non-progressive neuro-muscular disorder in children resulting from an injury in the central nervous system. Individuals with SCP present with impairments such as hyperreflexia, demonstrate impaired motor control and muscle growth. Manual stretching is an important approach in the physical therapy of individuals with SCP used to increase muscle extensibility and length, decrease muscle stiffness, and to improve functional abilities. However, there are only a few studies that have examined its acute and long-term effects in children with SCP and it is still not clear, if it may lead to the expected changes, and which method might be the most-effective one. Besides static stretching, proprioceptive neuromuscular facilitation (PNF) stretching has been used to aid the rehabilitation of, for example, stroke patients by either facilitating muscle elongation and/or improving muscle strength. Positive effects were found (e.g., increased dorsiflexion, improved gait function, altered tendon properties), which are also clinically relevant for individuals with SCP. However, there is no information about the impact of PNF in this population.

Aims: The primary aim of this study is to gain knowledge about both the effects of a single bout of static and PNF stretching and the effects of 8-week static and PNF stretching training on the calf muscle-tendon properties in children with SCP. Furthermore, the effects on joint and muscle function, stretch reflexes, gait, and self-reported gait function and functional performance are examined to receive a comprehensive picture of potential changes. Further aims of this study are to identify which stretching technique might be more efficient by comparing the effects of both stretching interventions, and to gain information about the influence of foot flexibility on the stretch achieved by the spastic gastrocnemius muscle-tendon unit.

Methods: A randomized controlled trial with a cross-over design will be performed. Prior to the measurements, a familiarization session takes place and both groups will further be examined in three separate measurement sessions. Based on a power calculation and in order to account for possible dropouts, 30 individuals with SCP (age range: 6 to 15 years) will be recruited. The participants will be randomly allocated to either the static stretching or PNF stretching intervention after the familiarization session. Passive muscle-tendon morphological properties will be examined. A manually controlled instrumented spasticity assessment will be performed to test for differences in the reflex responses. Information about the lengthening behavior of the tissues throughout the dorsiflexion rotations will also be collected by use of ultrasound. Isometric muscle strength and the active torque-angle relationship will be investigated using an isokinetic dynamometer. To assess the gait pattern of the children, a gait analysis will be performed by use of an 8-camera motion capture system. In addition, we will examine the participants' gait function and functional performance by use of the Gait Outcomes Assessment List questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • spastic cerebral palsy
  • ambulatory children and adolescents
  • ability to accept and follow verbal instructions
  • no severe contracture of the calf muscles (max. ankle dorsiflexion >= 0°, with knees extended)
  • classified as GMFCS level I, II, or III
  • aged between 6 and 5 years
  • willingness to participate

排除标准

  • others than spastic forms of cerebral palsy
  • severe mental retardation
  • fixed muscle contractures (ankle equinus deformity = max. ankle dorsiflexion <= 0°, with knees extended)
  • oral anti-spastic and/or muscle relaxation medication in the last 6 months
  • orthopaedic surgery and/or Botulinum toxin type A application in the last 12 months

结局指标

主要结局

Change in spasticity/stretch hyperreflexia

时间窗: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

Stretch reflex responses assessed by a manually controlled instrumented spasticity assessment

Change in active moment-angle relationship

时间窗: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

Maximum isometric voluntary contractions at specific ankle joint angles (isokinetic dynamometry)

Change in joint range of motion

时间窗: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)

Change in mechano-morphological muscle-tendon properties

时间窗: baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks)

Gastrocnemius medialis muscle morphology, muscle stiffness, tendon-aponeurosis length and stiffness, muscle-tendon unit length and stiffness, elongations of the tissues

次要结局

  • Change in gait characteristics(familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks))
  • Change in maximal isometric muscle strength(baseline (T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks))
  • Change in self-reported gait, mobility, and functional performance(familiarisation session (T0, 1-week before T1), post-measurement (T2, 8 weeks), follow-up measurement (T3, 16 weeks))

研究者

发起方
University of Graz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Annika Kruse

Principal investigator

University of Graz

研究点 (2)

Loading locations...

相似试验