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临床试验/NCT01564433
NCT01564433已完成早期 1 期

The Effects of an Electromechanical Gait Trainer in Gait Impairments and Endurance in Patients With Cerebral Palsy: a Randomized Control Trial

Universita di Verona2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Six Minute Walking Test

研究概览

简要总结

Cerebral Palsy (CP) describes a group of chronic conditions affecting body movement and muscle coordination caused by damage to one or more areas of the brain, usually occurring during fetal development or infancy. One of the most disabling mobility impairments in CP is gait impairment, clinically characterized by reduced speed and endurance, as well as reduced step, stride length and toe clearance during gait.

Recently, gait rehabilitation methods in patients with neurological impairment have relied on technological devices, which drive the patient's gait in a body-weight support condition and emphasize the beneficial role of repetitive practice. Early studies in gait rehabilitation in patients with CP were carried out by using partial body-weight support treadmill training (PBWSTT) and robotic-assisted treadmill therapy. Despite their potential, these technologies have practical limitations in their routine application.

More recently, several studies have focused on the use of a new electromechanical gait trainer (Gait Trainer GT I; Reha-Stim, Berlin, Germany) in adult patients who have experienced a stroke. They have shown that training with this device may significantly improve gait performance. Despite the clinical impact of this new rehabilitative procedure, to date, no studies have been conducted on its use in children with CP.

详细描述

Cerebral Palsy (CP) describes a group of chronic conditions affecting body movement and muscle coordination caused by damage to one or more areas of the brain, usually occurring during fetal development or infancy. The motor disorders of CP are often accompanied by disturbances of sensation, cognition, communication, perception, behavior, and/or a seizure disorder. One of the most disabling mobility impairments in CP is gait impairment, clinically characterized by reduced speed and endurance, as well as reduced step, stride length and toe clearance during gait.

Recently, gait rehabilitation methods in patients with neurological impairment have relied on technological devices, which drive the patient's gait in a body-weight support condition and emphasize the beneficial role of repetitive practice. The rationale for these approaches originates from animal studies which have shown that repetition of gait movements may enhance spinal and supraspinal locomotor circuit.

Early studies in gait rehabilitation in patients with CP were carried out by using partial body-weight support treadmill training (PBWSTT) and robotic-assisted treadmill therapy. The majority of these studies consisted of single case, small or unselected patient samples and/or uncontrolled trials. In a recent randomized control trial study, Willoughby et al. showed that PBWSTT was no more effective than overground walking for improving walking speed and endurance in children with CP. They concluded that the progressive reduction of body weight support along with adding concurrent overground walking practice to a treadmill training protocol may increase the intensity of training and assist with carry over of improvements to overground walking. Despite their potential, these technologies have practical limitations in their routine application: PBWSTT requires the assistance of one or two physiotherapists to control the patient's weight shift and lower limb position during training and proper placement of the patient onto the machine (Lokomat, Hokoma Inc., Volketswill, Switzerland) for robotic-assisted treadmill training is time-consuming.

More recently, several studies have focused on the use of a new electromechanical gait trainer (Gait Trainer GT I; Reha-Stim, Berlin, Germany) in adult patients who have experienced a stroke. They have shown that training with this device may significantly improve gait performance. Despite the clinical impact of this new rehabilitative procedure, to date, no studies have been conducted on its use in children with CP.

The primary aim of the present randomized controlled trial is to evaluate whether repetitive locomotor training with the Gait Trainer GT I can improve endurance in tetra- or diplegic ambulatory children with CP. The secondary aim was to assess whether training can also have a positive impact on spatiotemporal gait parameters and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • bilateral lower limb (diplegic or tetraplegic) Cerebral Palsy
  • 10 to 16 years of age
  • GMFCS levels II to IV
  • walk by themselves or with the use of an assistance device for at least 10 meters
  • maintain a sitting position without assistance
  • follow instructions and participate in the rehabilitative program

排除标准

  • lower limb spasticity >2 on the Modified Ashworth Scale
  • severe lower limb contractures
  • cardiovascular diseases
  • orthopedic surgery or neurosurgery in the past 12 months or Botulinum toxin injections within 6 months before the beginning of the study

结局指标

主要结局

Six Minute Walking Test

时间窗: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

The patient will be asked to walk at her/his self-selected walking speed in the gym along during the instrumental test.

次要结局

  • Ten Meter Walking Test(All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU)
  • Wee FIM(All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU)
  • Spatio-temporal gait analysis(All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU)

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Smania, MD, Clinical Professor

Prof. Smania Nicola

Universita di Verona

研究点 (2)

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