An interventional study of Robotic gait training and tRHB in Multiple Sclerosis and Gait Disorders, Neurologic, sponsored by Multiple Sclerosis Center of Catalonia. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Multiple Sclerosis Center of Catalonia · Not applicable, Interventional, and Prevention
This trial is a prospective, randomized, rater-blinded study (cRHB (N=30) vs RAGT (N=30)). For the control group, this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week, under the supervision of a qualified rehab team.
For the intervention group (RAGT) this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week, under the supervision of a qualified rehab team.
Informed consent will be obtained from patients prior to inclusion in the study, which will be carried out in accordance with the Declaration of Helsinki.
Aims
Primary Aim:
To compare the effect of Robot-Assisted Gait Training (RAGT) using the Atalante self-balance exoskeleton with conventional rehabilitation training (cRHB) for improving Walking speed measured by the Timed 10-meters walk test (10-MWT), considering a clinically relevant change an improvement of 20% of the velocity (m/s) with respect to the baseline assessment.
Secondary Aims:
To compare the effect of RAGT using the Atalante self-balance exoskeleton with conventional Rehabilitation training (cRHB), for improving static balance, dynamic balance, mobility, and self-perception of gait impairment measured with:
To compare the effect of RAGT using the Atalante self-balance exoskeleton with conventional Rehabilitation training (cRHB) on quality of life, emotional status and fatigue measured at pre and post-intervention with:
Materials And methods
Design:
This trial is a prospective, randomized, rater-blinded study (cRHB (N=30) vs RAGT (N=30)).
For the control group, this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week, under the supervision of a qualified rehab team.
For the intervention group (RAGT) this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week, under the supervision of a qualified rehab team.
Additionally, peripheral blood (6ml) will be taken from all subjects at three timepoints: at baseline (T1), after the 8 weeks of rehabilitation treatment (T2) and, if possible, one year after T4. Biological samples will then be given a unique identifier and transferred to researchers for analysis.
Informed consent will be obtained from patients prior to inclusion in the study, which will be carried out in accordance with the Declaration of Helsinki.
Enrollment and Screening Subjects will be evaluated for their eligibility from neurorehabilitation and neurology outpatient clinics at the Multiple Sclerosis Center of Catalonia (Cemcat).
Potential subjects will be referred to the study via Cemcat Physicians. A member of the research team will screen the referral and confirm they meet the necessary inclusion and exclusion criteria. Following confirmation of criteria, potential subjects will be contacted by phone to schedule an initial visit for consent and baseline assessment.
Additionally, peripheral blood (6ml) will also be taken from all subjects at baseline (T1).
Prior to all testing
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Multiple Sclerosis Center of Catalonia is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male or female, between 18 and 75 years of age.
Atalante is able to accommodate the following limb lengths:
Distance between the ground and the joint space of the knee (to be measured while wearing the shoes they intend to wear with Atalante):
Exclusion Criteria:
Pregnancy.
Ranges of motion below:
Participants randomize to receive a tRHB, will be trained 3 times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. A standardized protocol based on the usual clinical practice of physiotherapy in people with multiple sclerosis will be follow, according to patient characteristics, to design the sessions based on the patient objectives to be achieved, choosing the type of specific exercises to be performed based on the patient's condition and with the possibility of adapting them to their evolution during the twenty-four sessions.
Other: tRHB
RAGT group, will be trained 3-times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. Training intensity will be monitored and standardized using the Borg Rating of Perceived Exertion scale, and will progress from 'fairly light' to 'somewhat hard'. Progression will occur by increasing the number of steps in each session and decrease the level of assistance. Participants will be secured with the appropriately 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). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
Device: Robotic gait training
RAGT group, will be trained 3-times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. Training intensity will be monitored and standardized using the Borg Rating of Perceived Exertion scale, and will progress from 'fairly light' to 'somewhat hard'. Progression will occur by increasing the number of steps in each session and decrease the level of assistance. Participants will be secured with the appropriately 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). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
Also known as: Robotic, Atalante Gait Training
Participants randomize to receive a tRHB, will be trained 3 times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. A standardized protocol based on the usual clinical practice of physiotherapy in people with multiple sclerosis will be follow, according to patient characteristics, to design the sessions based on the patient objectives to be achieved, choosing the type of specific exercises to be performed based on the patient's condition and with the possibility of adapting them to their evolution during the twenty-four sessions.
Also known as: Physical therapy, gait training
Timed 10-meters walk test (10-MWT),
\- To compare the effect of RAGT by use of Atalante self-balance exoskeleton with conventional rehabilitation training (cRHB) for improving Walking speed measured by the Timed 10-meters walk test (10-MWT), considering a clinically relevant change an improvement of 20% of the velocity (m/s) with respect to the baseline assessment.
Time frame: 2 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis Center of Catalonia