Cerebral Palsy Clinical Trial
Official title:
The Effects of an Electromechanical Gait Trainer in Gait Impairments and Endurance in Patients With Cerebral Palsy: a Randomized Control Trial
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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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