Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis

NCT06921551•ABLE Human Motion S.L.

Summary

The goal of this study is to explore the potential clinical benefits of the ABLE Exoskeleton as part of a rehabilitation program in people with multiple sclerosis. The main question it aims to answer is: Can a rehabiliation program with the ABLE Exoskeleton help to mantain the physical and psychosocial health of people with multiple sclerosis? Participants will: * Have a gait training session of 60 min with the exoskeleton once a week for 12 months at the clinic * Have an evaluation (tests and questionnaires) every 3 months at the clinic

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 to 70 years old
•Diagnosed with multiple sclerosis
•Currently undergoing outpatient physical therapy treatment at the investigation site
•Ability to give informed consent

Exclusion Criteria

•Significant osteoporosis that may increase the risk of fracture
•Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years
•Spinal instability (or spinal orthoses, unless authorized by a physician)
•Severe spasticity: Level 4 on the Modified Ashworth Scale
•Orthostatic hypotension. Inability to tolerate a minimum of 30 minutes standing
•Uncontrolled autonomic dysreflexia
•Medical instability
•Unstable cardiovascular system (CVS), hemodynamic instability, untreated hypertension (SBP\>140, DBP\>90 mmHg), unresolved deep venous thrombosis (DVT)
•Serious comorbidities, including any condition that a physician deems inappropriate for use of the ABLE Exoskeleton or to complete participation in the study
•Skin integrity problems on the contact surfaces of the device or that would prevent sitting
+8 more criteria

Locations (1)

Fundación Esclerosis Múltiple Madrid (FEMM)

Madrid, Madrid, Spain

Key Dates

Start Date

April 7, 2025

Primary Completion Date

May 7, 2026

Completion Date

May 7, 2026

Last Updated

January 27, 2026

Enrollment

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

ABLE Exoskeleton

DEVICE

Intermittent Hypoxia in Persons With Multiple Sclerosis

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Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

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Secondary Progressive Multiple Sclerosis (SPMS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

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