Skip to main content

Table 1 Inclusion and exclusion criteria.

From: Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury: a framework towards the standardisation of clinical evaluations

Inclusion Criteria

Exclusion Criteria

∙ 18–70 years of age

∙ Traumatic and non-traumatic SCI

∙ AIS grade A to–D with sufficient arm strength to support body weight on a walking frame

∙ Currently receiving treatment as an inpatient or outpatient at one of the investigational sites

∙ Ability to give informed consent

∙ WISCI II [19] without exoskeleton of > 16

∙ History of lower-limb fragility fractures in the last 2 years

∙ 5 or more risk factors present for fragility fractures as stated by Craven et al. [18]

∙ Deterioration > 3 points of the total ISNCSCI motor score within the last 4 weeks

∙ Spinal instability

∙ Modified Ashworth scale [20]  > 3 in lower limbs

∙ Unable to tolerate 30 min standing without clinical symptoms of orthostatic hypotension

∙ Unable to perform a sit-to-stand transfer or stand in the device with assistance

∙ Psychological or cognitive issues that do not allow the participant to follow the study procedures

∙ Known pregnancy or breastfeeding

∙ Any neurological condition other than SCI

∙ Medically unstable (Unstable CVS, hemodynamic instability, untreated hypertension (SBP > 140, DBP > 90 mmHg), unresolved DVT, uncontrolled AD)

∙ Severe comorbidities (any condition that a physician considers to not be appropriate to complete participation in the study)

∙ Ongoing skin issues (Grade I or higher on the European Pressure Ulcer Advisory Panel (EPUAP) scale [23] on areas that will be in contact with the exoskeleton)

∙ Height, width, weight or other anatomical constraints (such as leg length differences) incompatible with the device

∙ Insufficient ROM for device preventing a participant to achieve a normal gait pattern or to complete a sit-to-stand/stand-to-sit transition (hip joint: insufficient ROM for step length, knee joint: insufficient ROM for standing, ankle: insufficient ROM to reach neutral position)

  1. Abbreviations are defined in the Abbreviations section