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

ABLE Human Motion S.L.19 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Interventions

ABLE ExoskeletonDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Fundación Esclerosis Múltiple Madrid (FEMM)

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

Number of therapeutic objectives achieved

Two therapeutic objectives per participant will be defined at baseline. At the end of the training program, it will be assessed if the objectives were accomplished or not.

Time frame: From baseline to the end of the training program at 12 months

Lower extremity muscle strenght

The Daniels Muscle Testing scale will be used to measure the strength of muscles in the lower extremities at baseline, every 3 months and at the end of the gait training program to assess motor function after the training. Scores range from 0 (absence of muscle activity) to 5 (normal muscle activity)