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

NCT05563402 | Completed

• 1 other identifier: PR(AG)285/2022
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis; Ataxia; Paraplegia

Keywords

exoskeletons; bioengineering; biomechanics;; biomechatronics;; rehabilitation robotics; Atalante

Outcome Measures

Primary Outcomes (1)

• To describe usability of Robotic-Assisted Gait therapy (RAGT) using the Atalante self-balance exoskeleton for persons with multiple sclerosis (PwMS) and explore patient characteristics related to this feature.

  Defining usability as a quality attribute that evaluates the ease of use of user interfaces, evaluating the perspective of patients by the Satisfaction Quebec user Evaluation of Satisfaction with assistive technology (QUEST) score and a questionnaire specific to the use of Atalante device. Defining high Usability as: Obtaining a positive score greater than or equal to 70% of the total possible score on the Satisfaction Quebec user Evaluation of Satisfaction with assistive technology (QUEST) score.

  4 months

Secondary Outcomes (7)

• To describe safety and occurrence of adverse effect of Robotic-Assisted Gait therapy (RAGT) using the Atalante self-balance exoskeleton for persons with multiple sclerosis (PwMS).

  4 months

• To describe safety of Robotic-Assisted Gait therapy (RAGT) using the Atalante self-balance exoskeleton for persons with multiple sclerosis (PwMS), measured by the occurrence of pressure ulcers

  4 months

• To describe the effect at the functional level of RAGT using the Atalante self-balance exoskeleton for improving Balance outcome.

  4 months

• To describe the effect at the functional level of RAGT using the Atalante self-balance exoskeleton for improving Walking speed, quality of life, depression.

  4 months

• To describe the effect at the functional level of RAGT using the Atalante self-balance. Physiological Changes at Bowel Dysfunction

  4 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Therefore, the investigators propose an, open, non-randomized 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.

Device: Atalante

Interventions

Atalante DEVICE

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).

Treatment arm

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, between 18 and 65 years of age
• Confirmed diagnosis of MS
• Expanded Disability Status Scale (EDSS) de Kurtzke from 6.0 to 7.0
• Able to verticalize on a daily basis
• Stable course of disease-modifying therapy over the past 6 months
• Clinical comorbidity asymptomatic (i.e., no underlying cardiovascular disease)
• Height: between approximately 1.60 and 1.90 m.
• Willingness to visit the Multiple Sclerosis Center of Catalonia (CEMCAT) for testing and training.
• Gait disorder conditioned by paresis or hemiparesis associated with ataxia or sensory problems
• Patient having given written consent
• Atalante is able to accommodate the following limb lengths:
• Thigh: 380-460mm
• Distance between the ground and the joint space of the knee (to be measured while wearing the shoes they intend to wear with Atalante):
• mm for patient with an ankle dorsiflexion ≥ 16°
• mm for patient with an ankle dorsiflexion between 13° et 16°

You may not qualify if:

• Pregnancy
• Starting or switching from fampridine (Fampyra®) in the last 4 weeks
• Height and weight outside the secure standard of safe use, described in the safety guides
• Contraindications to training with Atalante (eg, bone instability, history of osteoporosis or osteoporotic fractures)
• Subjects under Corticosteroids treatment or relapse
• Changes in disease-modifying and symptomatic therapy for MS during the study period
• Subjects with psychiatric or cognitive comorbidities that may interfere with the trial
• Whose joint centers cannot be aligned Atalante's
• Ranges of motion below:
• Knee: 5° extension, 110° flexion
• Ankle: 0° dorsiflexion, 9° plantar flexion, 18° inversion and eversion
• Hip: 115° flexion, 15° extension, 17° abduction, 10° adduction, 10°
• medial rotation, 20° lateral rotation
• Severe spasticity (greater than Ashworth 3) or uncontrolled clonus
• Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores

Sponsors & Collaborators

• Multiple Sclerosis Center of Catalonia: lead

Study Sites (1)

Centre d'Esclerosi Mútiple de Catalunya (Cemcat) - Barcelona, Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis; Ataxia; Paraplegia

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Officials

• Xavier Montalban, PHD

  Multiple Sclerosis Center of Catalonia

  STUDY DIRECTOR

• Carmen Tur Gomez, PHD

  Multiple Sclerosis Center of Catalonia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: October 3, 2022
• Study Start: September 20, 2022
• Primary Completion: December 20, 2022
• Study Completion: March 30, 2023
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)