"Evaluation of Usability and Safety of the Self-balancing Walking System Atalante in Patients With Multiple Sclerosis"

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.

Conditions

• Ataxia
• Paraplegia
• Multiple Sclerosis

Interventions

DEVICE

Atalante

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).

Sponsors & Collaborators

• Multiple Sclerosis Center of Catalonia

  lead OTHER

Principal Investigators

• Xavier Montalban, PHD · Multiple Sclerosis Center of Catalonia

• Carmen Tur Gomez, PHD · Multiple Sclerosis Center of Catalonia

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

10 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-20

Primary Completion

2022-12-20

Completion

2023-03-30

Countries

• Spain

Study Locations