NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Multiple Sclerosis Center of Catalonia
Conditions: Multiple Sclerosis, Gait Disorders, Neurologic
Interventions: Robotic gait training, tRHB
Countries: Spain
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.
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.- Barcelona, Barcelona, Spain