Multiple SclerosisEXONCT05563402
"Evaluation of Usability and Safety of the Self-balancing Walking System Atalante in Patients With Multiple Sclerosis"
A study testing Atalante in people with Multiple Sclerosis and Ataxia, run by Multiple Sclerosis Center of Catalonia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Ataxia, Paraplegia
- What is being tested?
- Atalante
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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):
- 457-607mm for patient with an ankle dorsiflexion ≥ 16°
- 457-577mm for patient with an ankle dorsiflexion between 13° et 16°
- 457-567mm for patient with an ankle dorsiflexion between 10° et 13°
- 457-557mm for patient with an ankle dorsiflexion between 0° and 10°
- Hip with less or equal to 460mm when seated
- Maximum weight:90 kg
Who cannot join
- 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
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- 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
- Active implantable medical device
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centre d'Esclerosi Mútiple de Catalunya (Cemcat) - Barcelona, Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Ataxia, Paraplegia
- Being tested
- Atalante
- Keywords
- exoskeletons, bioengineering, biomechanics;, biomechatronics;, rehabilitation robotics, Atalante
- Medical subject headings
- Multiple Sclerosis, Ataxia, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtalanteDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Atalante |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 using a specific questionnaire to the use of Atalante device (the modified Gagnon questionnaire).
Defining high Usability as: Obtaining a positive score greater than or equal to 70% of the total possible score on the Evaluation of Satisfaction.
Measured: 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).
- Defining a low occurrence as the appearance of an adverse effect related to the rehabilitation program in less than 10% of the reported patients. Defining an adverse event later in the chapter on instructions for reporting adverse events
Measured: 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
- The occurrence of pressure ulcers more than grade 1 in more than 10% of reported patients. Not taking into account the pressure zones that can be considered as an acceptable effect within the program as long as it is reversible in minutes after the program.
Measured: 4 months
To describe the effect at the functional level of RAGT using the Atalante self-balance exoskeleton for improving Balance outcome.
- Balance: Assess the effect of RAGT at the balance outcome measured by the Berg scale, considering a clinically relevant change for improvement in balance as measured by Berg scale was +3 points, meaning that PwMS are likely to perceive that as a reproducible and clinically important change in them balance performance.21
Measured: 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.
- Walking speed: Assess the effect of RAGT at the walking speed measured by the ten-meters walking test (10-MWT), considering a clinically relevant change as an improvement of 20% of the score with respect to the baseline assess.
Measured: 4 months
To describe the effect at the functional level of RAGT using the Atalante self-balance. Physiological Changes at Bowel Dysfunction
- Physiological Changes: Observe the effect of RAGT at the bowel function using the Neurogenic Bowel Dysfunction Spanish version,
Measured: 4 months
To describe the effect at the self-perception and psychological level of RAGT using the Atalante self-balancing exoskeleton to improve quality of life.
- Using the Multiple Sclerosis Quality of Life-54 Survey Spanish version
Measured: 4 months
To describe the effect at the self-perception and psychological level of RAGT using the Atalante self-balancing exoskeleton to improve quality of life and depression.
- Hospital Anxiety and Depression Scale considering a clinically relevant change of 1.7 points
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start20 Sep 2022
- Primary completion20 Dec 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Multiple Sclerosis Center of Catalonia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edwin Roger Meza Murillo, Multiple Sclerosis Center of Catalonia
- Investigators
- Xavier Montalban, PHD, Study director, Multiple Sclerosis Center of CataloniaCarmen Tur Gomez, PHD, Study director, Multiple Sclerosis Center of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563402
- Sponsor's protocol ID
- PR(AG)285/2022
- Acronym
- EXO
- Status last verified
- Jul 2026
- First submitted
- 19 Sep 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of Usability and Safety of the Self-balancing Walking System Atalante in Patients With Multiple Sclerosis"
- ClinicalTrials.gov ID
- NCT05563402
- Acronym / sponsor ID
- EXO / PR(AG)285/2022
- Conditions
- Multiple Sclerosis, Ataxia, Paraplegia
- Keywords
- exoskeletons, bioengineering, biomechanics;, biomechatronics;, rehabilitation robotics, Atalante
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Multiple Sclerosis Center of CataloniaUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: AtalanteTherefore, 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. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtalanteAtalante 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). | Device | Treatment arm |
Primary outcome
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.
Time frame: 4 months
Defining usability as a quality attribute that evaluates the ease of use of user interfaces, evaluating the perspective of patients using a specific questionnaire to the use of Atalante device (the modified Gagnon questionnaire). Defining high Usability as: Obtaining a positive score greater than or equal to 70% of the total possible score on the Evaluation of Satisfaction.
7 secondary outcomes
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).
Time frame: 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
Time frame: 4 months
To describe the effect at the functional level of RAGT using the Atalante self-balance exoskeleton for improving Balance outcome.
Time frame: 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.
Time frame: 4 months
To describe the effect at the functional level of RAGT using the Atalante self-balance. Physiological Changes at Bowel Dysfunction
Time frame: 4 months
To describe the effect at the self-perception and psychological level of RAGT using the Atalante self-balancing exoskeleton to improve quality of life.
Time frame: 4 months
To describe the effect at the self-perception and psychological level of RAGT using the Atalante self-balancing exoskeleton to improve quality of life and depression.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Montalban, PHD study director
Multiple Sclerosis Center of Catalonia
Carmen Tur Gomez, PHD study director
Multiple Sclerosis Center of Catalonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atalante in people with Multiple Sclerosis and Ataxia, run by Multiple Sclerosis Center of Catalonia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.