Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ABLE Human Motion S.L.
With
Fundación Esclerosis Múltiple Madrid (FEMM)
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 to 70 years old
Diagnosed with multiple sclerosis
Currently undergoing outpatient physical therapy treatment at the investigation site
Ability to give informed consent
You may not be if
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
