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

NCT ID: NCT06921551

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2026-05-07

Brief 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

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention with exoskeleton

Participants will undergo 60-min gait training sessions with the exoskeleton as part of their rehabilitation program once a week for up to 12 months

Group Type: EXPERIMENTAL

ABLE Exoskeleton

Intervention Type: DEVICE

Participants will undergo 60-min gait training sessions with the exoskeleton once a week for up to12 months

Interventions

ABLE Exoskeleton

Participants will undergo 60-min gait training sessions with the exoskeleton once a week for up to12 months

Intervention Type: DEVICE

Eligibility Criteria

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
• Grade I or higher on EPUAP (European Pressure Ulcer Advisory Panel, 2019) on areas that will be in contact with the exoskeleton
• Colostomy
• Anthropometric measurements outside the values compatible with ABLE Exoskeleton. In particular, height not between 1.5-1.9 m, or weight over 100 kg
• Anatomical constraints (such as eg length differences, users unable to position themselves inside the device) that are incompatible with the device
• Restrictions in range of motion that prevent normal gait from being achieved or preventing the completion of a normal transition from sitting to standing or standing to sitting
• Heterotopic ossification
• Known pregnancy or breastfeeding
• Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Esclerosis Múltiple Madrid (FEMM)

UNKNOWN

Sponsor Role: collaborator

ABLE Human Motion S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fundación Esclerosis Múltiple Madrid (FEMM)

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

CIV-24-10-049336

Identifier Type: OTHER

Identifier Source: secondary_id

ABLEexoMSpost

Identifier Type: -

Identifier Source: org_study_id