NCT06615947Completed
Conventional Multidisciplinary Gait Rehabilitation VR Robotic Self-balancing Based Gait Rehabilitation
Clinical Trial to Compare Conventional Multidisciplinary Gait Rehabilitation With the Atalante Self-balancing Walking System in Patients With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 5 Sept 2023
- Start date
- 28 Feb 2023
- Primary completion date
- 30 Mar 2025
- Lead sponsor
- Multiple Sclerosis Center of Catalonia
- Diseases
- Multiple sclerosis
- NCT number
- NCT06615947
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 28 Feb 2023 to the primary completion date, 30 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • 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 for Atalante training (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.
- Active implantable medical device.
Who the study is looking for
- • Male or female, between 18 and 75 years of age.
- Confirmed diagnosis of MS.
- EDSS from 6.0 to 7.0.
- Able to maintain the upright position 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 1.50 m. 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre d'Esclerosi Mútiple de Catalunya (Cemcat) - Barcelona, Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.