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

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

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.