Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.

The total number of adverse events and serious adverse events related to the investigational device at the end of the study will be measured.

The number and type of device errors or use errors during the training period.

The amount of use of the device during the home/community use period, as measured by the number of sessions and the walking time, number of steps, and distance walked per session.

The usability of the device as measured by the purpose and location of use of the device during the home/community use period which will be registered in a logbook by the participant.

The number and type of device errors at the end of the home/community use period will be registered.

The change from baseline to final assessment of the overall perceived health status of the participants, as measured by the scores of the 36-Item Short Form Survey Instrument (SF-36).

Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high Quality of Life. Lower scores indicate more disability, while higher scores indicate less disability.

The change from the Community Skills Test to the final exoskeleton assessment of the 6-Minute Walk Test (6MWT). The outcome will be the distance walked during the 6 minutes after the training period and once again after the home period.

The general user satisfaction of participants, companions, and therapists at the end of the study, as measured by the scores of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0).

12 item instrument used to assess satisfaction with a specific assistive device; eight of these items assess characteristics of that assistive device and the remaining four items assess service and include:

• Service delivery
• Repairs and service of the device
• Professionalism of service
• Follow-up service Participants are asked to rate their satisfaction for the device on a five point scale that ranges from "not satisfied" at all to "very satisfied." Finally, participants are asked to choose the three most important items related to the assistive device in question System Usability Scale (SUS) to measure the perceived usability of the device. The scales value from 0 to 4 (with four being the most positive response).

The 10 meter walk test will be used to compare performance after the training period and once again after the home period to monitor any changes in speed.

Blood draw test to check levels of high-density lipoprotein cholesterol (HDL-c), Low-Density Lipoprotein Cholesterol (LDL-c), Triglyceride (TG), and Total Cholesterol (TC).

Improvement is indicated with lower values of LDL-c and lower Triglycerides

Spirometry to assess the force vital capacity (FVC). FVC is crucial for evaluating lung function and respiratory and global health. Improvement indicates higher values of FVC.

Visual analog scale (VAS) is a self-report tool that allows individuals to rate their perceived level of spasticity on a continuous scale, typically ranging from 0 to 10, where higher scores indicate greater severity. Spasticity is a complex phenomenon that can vary greatly in intensity and impact from person to person. The VAS provides a means for individuals to subjectively quantify and communicate their experience of spasticity, capturing nuances that may not be fully captured by objective measures alone. 0 indicated no spasticity and 10 indicates the most spasticity experienced.

Bladder Management Difficulties and Bowel Management Difficulties items from the Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire. The SCI-QOL questionnaire is a validated measure specifically designed to assess the quality of life in individuals with SCI across various domains, including bladder and bowel function

Body weight provides valuable information about body composition.

Body Mass Index (BMI) is a simple and straightforward measure calculated using an individual's weight and height. BMI provides a numerical value that categorizes individuals into different weight status categories, such as underweight, normal weight, overweight, or obese.

Blood draw test to obtain the homeostatic model assessment (HOMA-IR), an indirect method to quantify insulin resistance and pancreatic β-cell function. HOMA-IR is a mathematical model used to estimate insulin resistance based on fasting glucose and insulin levels. Higher values indicate higher insulin resistance therefore an improvement would be a lower value.

The 8-item PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment questionnaire to measure alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours.

It assesses sleep disturbance over the past seven days. PROMIS instruments are scored using item-level calibrations on a 5 point likert scale from not at all to very much.

Higher T-scores indicate greater sleep disturbance.

Waist circumference measures the circumference of the waist at a specific point, typically at the level of the natural waist or the midpoint between the lower rib and the iliac crest. Lower values indicate better health.

Spirometry to assess the forced expiratory volume in 1 second (FEV1). FEV1 is crucial for evaluating lung function and respiratory and global health. A higher value indicates better respiratory function

Spirometry to assess the forced expiratory flow (FEF). FEF is crucial for evaluating lung function and respiratory and global health. A higher value indicates better respiratory function.

Spirometry to assess the peak expiratory flow (PEF). PEF is crucial for evaluating lung function and respiratory and global health. A higher value

Spirometry to assess the maximal voluntary ventilation (MVV). MVV is crucial for evaluating lung function and respiratory and global health. A higher value would indicate better lung function.

The Bristol Stool Scale categorizes stool consistency into seven distinct types, ranging from hard lumps (Type 1) to watery diarrhea (Type 7), based on visual descriptions and illustrations. The BSS provides a standardized and objective method for individuals to describe their stool consistency, facilitating communication with healthcare providers.