Robot-assisted Gait Training on Mobility in Severely Disabled Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Gait disabilities affect personal activities and quality of life of progressive multiple
      sclerosis (MS) patients. A robot-driven gait orthosis allowing a more effective support of
      walking movements and imitation of a nearly normal gait pattern during treadmill training at
      a higher speed has been developed and recently introduced in clinical settings. However,
      until now few studies evaluated the effects of Robot-Assisted Gait Training (RAGT) in a group
      of stroke, spinal cord injury and MS subjects.

      In addition, the training-induced neural and biological changes potentially related to the
      mechanisms of recovery remain undefined.

      The primary aims of this study are:

      to test the feasibility of RAGT in a group of progressive severely disabled MS patients and
      to test the hypothesis that this intensive intervention could have higher benefit, compared
      with conventional therapy alone, in mobility improvement as assessed by the Timed 25 Foot
      Walk (T25FW)

      The secondary aims of this study are:

      to determine whether fatigue, Quality of life, balance and locomotor function are improved by
      RAGT; to determine whether gait training influences markers of plasticity including clinical
      and circulating biomarkers to search for a possible correlation between clinical outcomes and
      clinical and circulating biomarkers
    

Detailed description: 
      This is a prospective, randomized, single-blinded, controlled study. Ninety-eight MS subjects
      will be recruited from the identification of subjects at U.O. Rehabilitative Medicine and
      Rare Diseases and Neuroimmune Center, IRCCS Neurosciences "Bellaria" (BO).

      After evaluation of their eligibility and when obtained the informed consent, patients will
      be enrolled and randomized to the two groups through a randomization stratification approach.
      Subjects will be grouped into strata defined by the degree of impairment (e.g. using outcomes
      from the Expanded Disability Status Scale or EDSS) and then randomized separately within each
      stratum according to a block randomization and will be assigned to one of the two treatment
      groups:

        1. robot-assisted gait training (experimental group)

        2. conventional therapy (control group)

      Robot-assisted gait training:

      Patients will receive 12 training sessions over 4 weeks (3 sessions/week) of RAGT. During
      these sessions subjects will wear a harness attached to a system to provide body weight
      support and they will walk on a treadmill with the help of a robotic-driven gait orthosis.
      The legs are guided according to a physiological gait pattern. The torque of the knee and hip
      drives can be adjusted from 100% to 0% for one or both legs. The speed of the treadmill can
      be adjusted from 0 km/h to approximately 3 km/h and body weight support from 0% to 100%.
      During the first session we will set these training parameters according to subject
      characteristics and demand level. As training will progress, adjustments in the assistance
      provided by the driven-gait orthosis, the amount of body weight support and treadmill speed
      will be performed. Training sessions will last for an hour with 30 minutes of real walking
      time, because subject set-up in the device take approximately 30 minutes.

      Conventional therapy:

      The control group will receive 12 conventional therapy sessions over 4 weeks (3
      sessions/week), that will focus on gait training. Subjects will receive 1 hour of individual
      conventional physiotherapy for session. During the first 5-10 minutes the subjects will
      perform lower-limb and core stretching exercises to increase muscles flexibility; then
      they'll deal with lower-limb muscles strengthening exercises tailored on their baseline
      characteristics (10 minutes). After that, assisted over-ground walking training will be
      performed.

      Outcome measures Outcome measures will be assessed a week before the treatment initiation
      (T0), after two weeks (T1), after 4 weeks (T2) and at 3 months follow-up (T3). Personnel
      blinded to the treatment will assess the effects of the intervention.
    

Intervention name(s): Robot-assisted gait training; Conventional therapy
Intervention type(s): Device; Other
Intervention description(s): Patients will receive 12 training sessions, lasting for an hour with 30 minutes of real walking time, over 4 weeks (3 sessions/week) of RAGT. Subjects will wear a harness attached to a system to provide body weight support and they will walk on a treadmill with the help of a robotic-driven gait orthosis. The legs are guided according to a physiological gait pattern. The torque of the knee and hip drives can be adjusted from 100% to 0% for one or both legs. The speed of the treadmill can be adjusted from 0 km/h to approximately 3 km/h and body weight support from 0% to 100%. During the first session we will set these parameters according to subject characteristics and demand level. As training will progress, adjustments in the three parameters previously described will be performed.; The control group will receive 12 conventional therapy sessions over 4 weeks (3 sessions/week), that will focus on gait training. Subjects will receive 1 hour of individual conventional physiotherapy for session. During the first 5-10 minutes the subjects will perform lower-limb and core stretching exercises to increase muscles flexibility; then they'll deal with lower-limb muscles strengthening exercises tailored on their baseline characteristics (10 minutes). After that, assisted over-ground walking training will be performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Gait