Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking

Analyze data regarding the safety of the UNILEXA exoskeleton by determining the incidence of adverse events (AEs) and adverse device effects (ADEs), such as falls, skin injuries, and other injuries, over the study period.

To assess improvements in health-related quality of life (QoL) using the WHOQOL-BREF questionnaire, a standardized questionnaire measuring QoL across four domains: physical, psychological, social relationships, and environment.

Scale range: 0-100. Interpretation: Higher scores indicate better quality of life.

To assess user satisfaction with the UNILEXA exoskeleton using the QUEST 2.0 questionnaire. This evaluates satisfaction with the device and associated services.

QUEST 2.0: A validated user satisfaction questionnaire consisting of 12 items across two subscales: device satisfaction and service satisfaction. Each item is rated on a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied).

To evaluate the time required to walk 10 meters at a comfortable speed.

Unit of Measure: Seconds. Interpretation: Lower times indicate better functional mobility.

To assess mobility performance by measuring the time required to stand up from a chair, walk 3 meters, turn, and return to sit in the chair.

Unit of Measure: Seconds. Interpretation: Lower times indicate better functional mobility.

To evaluate the level of physical assistance required during mobility tasks using a 6-point ordinal scale.

Scale range: 0-5, where 0 = no assistance and 5 = full physical assistance required.

Interpretation: Lower scores indicate better functional independence.

To evaluate the perceived exertion of participants during mobility tasks using the Borg RPE scale.

Borg RPE Scale: Measures exertion on a scale from 0-10, where 0 = no exertion and 10 = maximal exertion.

To assess the pain intensity experienced by participants during mobility tasks using the Visual Analog Scale (VAS).

VAS Scale: Measures pain on a scale from 0-10, where 0 = no pain and 10 = the worst imaginable pain.

To evaluate the cognitive and physical workload experienced by participants during mobility tasks using the NASA Task Load Index (NASA-TLX) questionnaire.

NASA-TLX: A multidimensional workload assessment tool with six subscales: mental demand, physical demand, temporal demand, performance, effort, and frustration.

Scale range: 0-20 for each subscale. Interpretation: Higher scores indicate greater workload in each category.

To assess compensatory movements by analyzing the amplitude of reflective markers placed on the acromion.

Parameters measured: Amplitude of vertical and lateral movements. Units of Measure: Millimeters (mm). Data summarization: Mean and standard deviation of marker amplitude across all trials.

To evaluate biomechanical adaptations by measuring the amplitude of pelvic angular movements in three major planes:

Pelvic Rotation: Angular displacement in the transverse plane. Pelvic Hiking: Angular displacement in the coronal plane. Pelvic Tilting: Angular displacement in the sagittal plane. Units of Measure: Degrees (°). Data summarization: Mean and standard deviation of angular displacement for each type of movement (rotation, hiking, tilting) across all trials.

To evaluate participant progress during the training phase by recording the number of steps taken in each training session.

Unit of Measure: Number of steps. Data summarization: Total number of steps per session and average across all sessions.

To assess participant mobility during the training phase by measuring the total distance walked in each training session.

Unit of Measure: Meters (m). Data summarization: Total distance walked per session and average across all sessions.

To assess participant endurance during the training phase by recording the duration of each training session.

Unit of Measure: Minutes. Data summarization: Total duration per session and average across all sessions.

To assess physiological responses during training sessions by measuring participants' heart rates.

Unit of Measure: Beats per minute (BPM). Data summarization: Average heart rate during each session and across all sessions.