Effects of Electromechanical Gait Trainer in Patients With Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT01564433|
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : June 14, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Procedure: Device: Electromechanical gait trainer Procedure: Convetional control treatment||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Effects of an Electromechanical Gait Trainer in Gait Impairments and Endurance in Patients With Cerebral Palsy: a Randomized Control Trial|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2012|
|Experimental: Gait trainer treatment||
Procedure: Device: Electromechanical gait trainer
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.
|Active Comparator: Conventional group||
Procedure: Convetional control treatment
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.
- Six Minute Walking Test [ Time Frame: 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.
- Ten Meter Walking Test [ Time Frame: 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 ]This is a validated test for the clinical evalua- tion of walking speed.21 The subject will be asked to walk at her/his self-selected walking speed along the central 10 m of a 14-m linoleum-covered walkway. A digital stopwatch will be used to time the walks.
- Wee FIM [ Time Frame: 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 ]This widely used scale for the evaluation of disability in children with CP investigates three main domains: self-care, mobility, and cognition (score, 18Y126; high, best performance).
- Spatio-temporal gait analysis [ Time Frame: 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 will be evaluated by using a computerized system called GAITRite system (Gold, version 3.2 b - CIR Systems, Inc, Havertown, PA). Patients will ask to ambulate along the 7.66m electronic walkway at their fastest speed. The following gait parameters will be considered: gait speed (cm/sec), cadence (step/min), stride length (cm), step length (cm), heel to heel base support (cm), swing of cycle (%), stance of cycle (%), single support of cycle (%) and double support of cycle (%)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564433
|S.S.O. di Riabilitazione dell'Ospedale Policlinico|
|Verona, Italy, 37124|
|Study Chair:||Antonio Fiaschi, Professor||Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy|