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

NCT06615947 | Completed

• 1 other identifier: PR(AG)05/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic

Outcome Measures

Primary Outcomes (1)

• Timed 10-meters walk test (10-MWT),

  \- To compare the effect of RAGT by use of 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.

  2 months

Study Arms (2)

Traditional Gait Rehabilitation training (tRHB

ACTIVE COMPARATOR

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.

Other: tRHB

Robot Gait training (RAGT):

EXPERIMENTAL

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.

Device: Robotic gait training

Interventions

Robotic gait training DEVICE

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.

Also known as: Robotic, Atalante Gait Training

Robot Gait training (RAGT):

tRHB OTHER

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.

Also known as: Physical therapy, gait training

Traditional Gait Rehabilitation training (tRHB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• mm for patient with an ankle dorsiflexion ≥ 16°
• mm for patient with an ankle dorsiflexion between 13° et 16°

You may not qualify if:

• 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.

Sponsors & Collaborators

• Multiple Sclerosis Center of Catalonia: lead

Study Sites (1)

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

Barcelona, Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Xavier Montalban, PHD

  Multiple Sclerosis Center of Catalonia

  STUDY DIRECTOR

• Carmen Tur Gomez, PHD

  Multiple Sclerosis Center of Catalonia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The eligibility of the subjects from the neurorehabilitation and neurology outpatient clinics of the Multiple Sclerosis Center of Catalonia (Cemcat) will be evaluated. And the blinded outcome assessor comes in for just one day to assess each individual, without any information about the therapy that was given to each patient.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 27, 2024
• Study Start: February 28, 2023
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)