Effects of Electromechanical Gait Trainer in Patients With Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      Multiple Sclerosis is a very disabling disorder in young adult patients leading to an
      important limitation in daily life activities and social participation. Among of the
      different causes of disability in MS patients gait impairments, fatigue and balance disorders
      can be considered as the main concerns. Thus, gait restoration in patients with MS is the one
      of the primary objective of rehabilitation and often influences whether a patient can return
      home or to work. Even if potentially innovative treatments like treadmill training have been
      proposed, nowadays the role of robotic assisted locomotion rehabilitation has not been
      extensively studied in patients with MS.
    

Detailed description: 
      Background Multiple sclerosis (MS) is the most common chronic disabling disease of the
      central nervous system in young adults. Gait disorders represent one of the greatest causes
      of disability in patients with MS. Thus, gait restoration in patients with MS is the one of
      the primary objective of rehabilitation and often influences whether a patient can return
      home or to work.

      Despite significant progress in the development of disease-modifying drugs, pharmacologic
      therapy alone does not warrant optimal care in MS. Exercise has been recognized as a feasible
      form of self-management for persons with the disease. Regular exercise can improve daily
      activity, cardiovascular fitness, muscle strength, health perception, and reduce fatigue in
      patients with MS.

      To restore gait, modern concepts of rehabilitation support a repetitive task-specific
      approach. In recent years it has also been shown that higher intensities of walking practice
      (resulting in more repetitions trained) result in better outcomes for patients after stroke.
      Recently, the introduction of robotic devices for gait rehabilitation have showed to be a
      feasible approach in order to improve gait ability in patients with stroke and spinal cord
      lesions. These devices allow to train patients under a graduated body weight support
      condition and to guide the patient's steps reproducing a physiologic gait pattern for as long
      as the clinical conditions allow. This activity can be executed requiring only supervision by
      a physiotherapist and in absolutely safety condition for the patient.

      Repetitive locomotor training is an innovative approach in gait disturbances in patients with
      multiple sclerosis. Only scant data on this issue is available and all these studies have
      been performed by means of conventional physiotherapy or treadmill training approaches.
      Nowadays the effectiveness of robotic devices for gait rehabilitation has not yet been
      evaluated in patients with multiple sclerosis.

      Aim of the study The aim of the study is to evaluate the effect of a repetitive locomotor
      training by electromechanical gait trainer on gait endurance, fatigue and activities daily
      life in patients with MS.

      Study Design Randomised controlled, blinded clinical trial. Materials and methods Fifty
      patients with definite diagnosis of MS according to McDonald criteria, and with EDSS score
      equal to or below 7 will be enrolled in the study. Patients with disease recurrence that
      worsens significantly during the 8 weeks before recruitment will be excluded. At the moment
      of recruitment (before treatment), at the end of treatment (6 weeks) and one month 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, 10-meter
      Walking Test, Fatigue Severity Scale, Multiple Sclerosis Quality Of Life-54, Hamilton Rating
      Scale for Depression, Falls Efficacy Scale. Instrumental assessment procedures: GAITRite®
      System, Stabilometric Assessment 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 the 10-meter Walking Test, Fatigue Severity
      Scale and the Multiple Sclerosis Quality Of Life-54, Hamilton Rating Scale for Depression,
      Falls Efficacy Scale, Spatio-temporal parameter with GAITRite® System, Stabilometric
      Assessment 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 (2 sessions/week) on Gait Trainer machine. 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). Expected results: we could
      hypothesize that the training performed by the experimental group could improve gait
      endurance and daily life disability in patients with MS.
    

Intervention name(s): Gait trainer treatment; Conventional treatment
Intervention type(s): Device; Other
Intervention description(s): Patients will be subjected to 40 minutes of repetitive locomotor therapy on the Gait Trainer (GTI) (Reha-Stim, Berlin, Germany), followed by 10 minutes of passive joint mobilization and stretching exercises. The first 40 min session will be divided as follow: 15 min gait training; 5 minutes at rest; 15 minutes gait training; 5 minutes at rest. 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.; 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: Single (Participant)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Robotic Rahabilitation; Fatigue; Gait disorder