Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT05563402
Eligibility Criteria:
Inclusion Criteria:
* 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):
* 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
Exclusion Criteria:
* 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
* Active implantable medical device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
70 Years
Study:
NCT05563402
Study Brief:
Protocol Section:
NCT05563402