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Search / Trial NCT06615947

Conventional Multidisciplinary Gait Rehabilitation VR Robotic Self-balancing Based Gait Rehabilitation

Launched by MULTIPLE SCLEROSIS CENTER OF CATALONIA · Sep 25, 2024

Trial Information

Current as of July 24, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

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-percept...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • 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.
  • 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 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.

About Multiple Sclerosis Center Of Catalonia

The Multiple Sclerosis Center of Catalonia is a leading research institution dedicated to advancing the understanding and treatment of multiple sclerosis (MS). Committed to innovative clinical trials, the center collaborates with a multidisciplinary team of experts in neurology, immunology, and rehabilitation to develop novel therapeutic strategies. With a focus on patient-centered care and cutting-edge research, the center aims to improve outcomes for individuals affected by MS while contributing to the global body of knowledge regarding this complex neurological condition. Its state-of-the-art facilities and commitment to ethical research practices position it as a key player in the field of MS research and clinical trials.

Locations

Barcelona, , Spain

Patients applied

0 patients applied

Trial Officials

Xavier Montalban, PHD

Study Director

Multiple Sclerosis Center of Catalonia

Carmen Tur Gomez, PHD

Study Director

Multiple Sclerosis Center of Catalonia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported