"Evaluation of Usability and Safety of the Self-balancing Walking System Atalante in Patients With Multiple Sclerosis"
Condition: Multiple Sclerosis; Ataxia; Paraplegia
MeSH terms: Multiple Sclerosis; Paraplegia; Sclerosis
Study type: Interventional

Summary: 
      Multiple sclerosis (MS) is the most prevalent chronic inflammatory disease of the central
      nervous system (CNS), affecting more than 2 million people worldwide,1 it is a degenerative
      disease that selectively affects the central nervous system and represents the main cause of
      non-traumatic disability in young adults.

      Gait and balance disturbances in MS are common even in the early stages of the disease. Half
      of the patients report some alteration in the quality of walking within the first month after
      diagnosis, reaching 90% after 10 years of evolution. 4 5 In addition, it is the symptom to
      which patients give the most importance 6 and the one that most conditions their activity and
      participation. 7 The causes of gait disturbance are multifactorial and are influenced by
      different aspects such as muscle strength, balance, coordination, proprioception, vision,
      spasticity, fatigue and even cognitive aspects4.

      There are multiple interventions, including aerobic, resistance training, yoga, and combined
      exercise, that have shown significant improvements in walking endurance, regardless of
      outcome measures (six-minute walking test (6MWT), two-minute walking test 2MWT). 8

      In recent years, evidence has been growing around rehabilitation with robotic equipment in
      people with multiple sclerosis (PwMS), in their study Ye et al. concluded that robotic
      locomotor training has limited impact on motor functions in multiple sclerosis, but improves
      fatigue and spasticity, is safe and well-tolerated for PwMS, and less demanding for physical
      therapists.10 Bowman et al. concluded that robot-assisted gait therapy (RAGT) improves
      balance and gait outcomes in a clinically significant way in PwMS, RAGT appears more
      effective compared to non-specific rehabilitation, while showing similar effects compared to
      non-specific rehabilitation. specific balance and gait training in studies with level 2
      evidence. RAGT has several advantages in terms of patient motor assistance, training
      intensity, safety and the possibility of combining other therapeutic approaches and should be
      promoted for PwMS with disability in a multimodal rehabilitation setting as an opportunity to
      maximize recovery.11 In this setting, more larger-scale and better-designed studies with
      longer training duration and more studies evaluating satisfaction, usability, and
      effectiveness are needed. of RAGT.
    

Detailed description: 
      Therefore, the investigators propose an open, non-randomized, pseudo-experimental study.

      This study protocol includes 12 one-hour RAGT training sessions for 4 weeks, three times a
      week, under the supervision of a qualified rehabilitation team.

      Informed consent will be obtained from patients before inclusion in the study, which will be
      carried out in accordance with the Declaration of Helsinki.

      With the aim of describing Usability as the main objective, and Safety as a secondary
      objective and functional changes at the level of balance, walking speed and quality of life.
    

Intervention name(s): Atalante
Intervention type(s): Device
Intervention description(s): Atalante Gait training: Using the Atalante System (self-reliant walking system), participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: exoskeletons; bioengineering; biomechanics;; biomechatronics;; rehabilitation robotics; Atalante