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

ABLE Human Motion

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Device: ABLE Exoskeleton

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06921551

ABLEexoMSpost

CIV-24-10-049336 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Intervention with exoskeleton

Experimental group

Description:

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

Treatment:

Device: ABLE Exoskeleton