Conventional Multidisciplinary Gait Rehabilitation VR Robotic Self-balancing Based Gait Rehabilitation
Spain60 participantsStarted 2023-02-28
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 ost…