Effects of Electromechanical Gait Trainer in Patients With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      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.
    

Detailed description: 
      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.

      Study Design Randomised controlled, blinded clinical trial.

      Materials and methods Twenty CP patients will be enrolled in the study. The inclusion
      criteria will be: bilateral lower limb (diplegic or tetraplegic) CP, 10 to 18 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 and follow instructions and
      participate in the rehabilitative program. The exclusion criteria will be: 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 and
      injections within 6 months before the beginning of the study.

      At the moment of recruitment (before treatment), at the end of treatment (6 weeks) and one
      month and two months after the end of the treatment (FU) each patient will be tested with the
      following clinical and instrumental procedures. Clinical assessment procedures: 6-minute
      Walking Test, Ten Meter Walking Test, Gross Motor Classification System, Child Health
      Questionnaire (CHQ-PF50) Italian version, Wee FIM and Energy Expenditure Index. Instrumental
      assessment procedures: Gait analysis by means of GAITRite® System and measure of energy cost
      by COSMED K4b2.

      As primary outcome measure will be considered the 6-minute Walking Distance Test. As
      secondary outcomes measures will be considered Ten Meter Walking Test, Gross Motor
      Classification System, Child Health Questionnaire (CHQ-PF50) Italian version, Wee FIM and
      Energy Expenditure Index, Spatio-temporal parameter with GAITRite® System and measure of
      energy cost by COSMED K4b2. The allocation in the two groups will be done with simple
      randomisation.

      Patients will be randomized into two groups. The first group (experimental group) will be
      subjected to 12 treatment session (3 sessions/week) on Gait Trainer machine for one month.
      The second group (control group) will undergo to a conventional treatment with the same
      duration and frequency of the experimental group. Data will be analysed by means parametric
      and non-parametric tests. Both, within and between groups comparison will be performed. Data
      will be analyzed using SPSS software (ver 11.0; SPSS Inc., Chicago, IL, USA).
    

Intervention name(s): Device: Electromechanical gait trainer; Convetional control treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): The experimental group will be subjected to 12-30 minute session (3 per week: Monday, Wednesday, Friday) of repetitive locomotor therapy on the Gait Trainer (Reha-Stim, Berlin, Germany), followed by 20 minutes of passive joint mobilization and stretching exercises. The GT-I consists of a double crank and rocker gear system, composed of two footplates positioned on two bars (coupler), two rockers, and two cranks that provide the propulsion. While using the gait trainer, individuals are secured in a harness and positioned on two footplates, whose movements simulate stance and swing phase, with a ratio of 60% to 40% between the two phases. The body weight was initially reduced by 30% and then progressively increased.; The control group will be subjected to a conventional treatment that will consist of three different sets of exercises: 1) passive joint mobilization and stretching of lower limb muscles; 2) muscle strengthening exercises; 3) gait exercises. Each set of exercises lasted 10, 15 and 15 min, respectively with 2,5 min at rest between each set for a total of 40 minutes.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: robotics; rehabilitation; gait; cerebral palsy