Patient-centered Assessment of the Effects of Powered Exoskeleton Use in People With Spinal Cord Injury

Incremental cost utility ratio (ICUR) associated to the treatment: it provides healthcare decision- makers and providers with a straightforward information, that is, how much a "unit of utility improvement" would cost them and/or the society. Assuming a timeframe of analysis and two alternative technologies or treatments A and B, ICUR is the ratio between the difference in costs and the difference in utility of A and B

Incidence of major adverse events related to the exoskeleton use: falls, bone fractures, skin lesions, pressure lesions, cardiovascular events

Strides and steps performed with the exoskeleton are counted automatically by the exoskeleton system. This parameters can be monitored by connecting to the exoskeleton system via a proprietary software.

The SUS evaluates the usability of the assistive technology. It consists in 10 items with five response options for respondents, from Strongly agree to Strongly disagree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. The higher the score, the higher the usability.

The QUEST evaluates a person's satisfaction with the assistive technology. It yields three scores: (i) Device, (ii) Services, and (iii) a total QUEST score. (i) consists of 10 items with five response options for respondents, from Strongly agree to Strongly disagree; the score is calculated by averaging the valid item responses; score range: 1-5. (ii) consists of 4 items with five response options for respondents, from Strongly agree to Strongly disagreeare; the score is calculated by averaging the valid item responses; score range: 1-5. (iii) is calculated by averaging the score of (i) and (ii). The QUEST presents a final section where the participants must indicate the three most important features of the technology.

The PHQ-9 aims at identifying probable major depressive disorder among adult primary care patients. It consists in 9 items with four response options for respondents, from Never to Almost always. The final score is calculated by summing the valid item responses. Score range: 0 -27. The higher the score, the higher the level of depression.

The GAD-7 assesses participant's anxiety. It consists of 7 items with four response options for respondents, from Never to Almost always. The final score is calculated by summing the valid item responses. Score range: 0 -21. The higher the score, the higher the level of anxiety.

The VO2 consumption is measured with a metabolic system throughout an exercise protocol with an arm-ergometer. According to previous study protocols, the VO2 consumption in the last 30 seconds of the arm-ergometer test are used to estimate the peak of VO2 consumption. After, this value is converted in METs.

The MAS assesses the resistance to passive range of motion about a single joint with a 6-point rating scale. It's performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension ( the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. The higher the score, the higher the muscular spasticity. The scores can assume the following values: 0 - No increase in tone;1 - slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension; 1+ - slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout the range of motion; 2 -more marked increase in tone but more marked increased in muscle tone through most limb easily flexed; 3 - considerable increase in tone, passive movement difficult; 4 - limb rigid in flexion or extension.

The Jobe's test aids in diagnosing rotator cuff tears or subacromial impingement. The examiner passively elevates the patient's shoulder to 90 degrees of abduction with internal rotation. The examiner then applies a downward pressure against the arm. A positive test is the provocation of pain or abnormal weakness.

The Speed's test is used to test for superior labral tears or bicipital tendonitis. To perform the Speed's Test, the examiner places the patient's arm in shoulder flexion, external rotation, full elbow extension, and forearm supination; manual resistance is then applied by the examiner in a downward direction. The test is considered to be positive if pain in the bicipital tendon or bicipital groove is reproduced In both test, the exerted force will be also measured using a dynamometer.

The SCIM assesses of the ability of SCI patients to perform basic activities of daily living. It assesses three subscales: (i) self-care, (ii) respiration and sphincter management, and (iii) mobility. (i) consists in 6 items with four or five response options for respondents. Score range: 0-20. (ii) consists in 4 items with three to six response options for respondents. Score range: 0-40. (iii) consists in 8 items with three to nine response options for respondents. Score range: 0-40. Each subscale score is evaluated separately by summing the valid item responses. The higher the score, the higher the level of independence.

The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression. It consists in a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain in this case) orientated from the left (worst) to the right (best).

The 5-Likert scale consists of a single item which investigates the patients self-perceived sphincter's functionality, ranging from 1 (worst case) to 5 (best case)

The 6 MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

The 10 MWT is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.