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ENROLLING BY INVITATION

NCT06615947

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

Sponsor: Multiple Sclerosis Center of Catalonia

View on ClinicalTrials.gov

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.

Official title: Clinical Trial to Compare Conventional Multidisciplinary Gait Rehabilitation With the Atalante Self-balancing Walking System in Patients With Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-02-28

Completion Date

2025-03-30

Last Updated

2024-09-27

Healthy Volunteers

Conditions

Multiple Sclerosis Gait Disorders, Neurologic

Interventions

DEVICE

Robotic gait training

RAGT group, will be trained 3-times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. Training intensity will be monitored and standardized using the Borg Rating of Perceived Exertion scale, and will progress from 'fairly light' to 'somewhat hard'. Progression will occur by increasing the number of steps in each session and decrease the level of assistance. Participants will be secured with the appropriately sized harness and attached to an overhead body-weight support system. Each session will begin with a 3-5-minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.

OTHER

tRHB

Participants randomize to receive a tRHB, will be trained 3 times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. A standardized protocol based on the usual clinical practice of physiotherapy in people with multiple sclerosis will be follow, according to patient characteristics, to design the sessions based on the patient objectives to be achieved, choosing the type of specific exercises to be performed based on the patient's condition and with the possibility of adapting them to their evolution during the twenty-four sessions.

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.

Locations (1)

Centre d'Esclerosi Mútiple de Catalunya (Cemcat) - Barcelona, Hospital Universitari Vall d'Hebron

Barcelona, Spain