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

Multiple Sclerosis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Ataxia
• Multiple Sclerosis
• Paraplegia
• Sclerosis

• NCT number: NCT05563402
• Study type: Interventional
• Source: Multiple Sclerosis Center of Catalonia
• Status: Completed
• Phase: N/A
• Start date: September 20, 2022
• Completion date: March 30, 2023