Conventional Multidisciplinary Gait Rehabilitation VR Robotic Self-bal
Clinical Trial to Compare Conventional Multidisciplinary Gait Rehabilitation With the Atalante Self-balancing Walking System in Patients With Multiple Sclerosis
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 19 months ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Robotic gait training
Compared with
- tRHB
What it measured
Main measures
Timed 10-meters walk test (10-MWT),
2 months
Walking and mobility
Who could take part
MS (type not specified) · 18 to 75 · EDSS 6.0 to 7.0
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Feb 2023
Main results due
Mar 2025
Finished
Mar 2025