Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting
The primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. Furthermore, the potential effects of the training on walking, and balance function, general health status, user satisfaction, and quality of life will be assessed.
- EligibilityCriteria: Inclusion Criteria:  18 to 70 years of age. Diagnosed with MS. Currently receiving treatment as an inpatient or outpatient at one of the investigational 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 of standing. Uncontrolled autonomic dysreflexia. Medically unstable 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. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult