What this trial measures

• Change in sessions recorded and provided by the exoskeleton device across study timepointsbaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  Indego device records and transmits electronically data regarding each session completed on device. These include the number of sessions, total number of steps, total time spent with device on, and total time spent walking. For each individual Indego session: number of steps, time of session, and time spent walking. From the last study checkpoint, the shortest time spent walking and longest time spent walking will also be recorded. Use habits will be recorded over the duration of the study from baseline to 12-months post-enrollment and it will be determined if use increases over time, decreases over time, or remains consistent. This outcome will address total and average number of Indego sessions completed per month.

• Change in time spent walking recorded and provided by the exoskeleton device across study timepointsbaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  Indego device records and transmits electronically data regarding each session completed on device. These include the number of sessions, total number of steps, total time spent with device on, and total time spent walking. For each individual Indego session: number of steps, time of session, and time spent walking. From the last study checkpoint, the shortest time spent walking and longest time spent walking will also be recorded. Use habits will be recorded over the duration of the study from baseline to 12-months post-enrollment and it will be determined if use increases over time, decreases over time, or remains consistent. This outcome measures average time spent walking per month measured in hours:minutes:seconds.

• Change in walking time recorded and provided by the exoskeleton device across study timepointsbaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  Indego device records and transmits electronically data regarding each session completed on device. These include the number of sessions, total number of steps, total time spent with device on, and total time spent walking. For each individual Indego session: number of steps, time of session, and time spent walking. From the last study checkpoint, the shortest time spent walking and longest time spent walking will also be recorded. Use habits will be recorded over the duration of the study from baseline to 12-months post-enrollment and it will be determined if use increases over time, decreases over time, or remains consistent. This outcome will measure total and average walking time in the Indego per month measured in hours:minutes:seconds.

• Change in usage metrics as reported by userbaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  Indego device records and transmits electronically data regarding each session completed on device. These include the number of sessions, total number of steps, total time spent with device on, and total time spent walking. For each individual Indego session: number of steps, time of session, and time spent walking. From the last study checkpoint, the shortest time spent walking and longest time spent walking will also be recorded. Use habits will be recorded over the duration of the study from baseline to 12-months post-enrollment and it will be determined if use increases over time, decreases over time, or remains consistent. This outcome will ask participant(s) if they feel like they are using their device more/less/same as last timepoint.

• Change in medical health status, assessed by interview and written questions based on the SCI Model Systems form II, between all timepoints in studybaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  Utilized the SCI Model Systems form II as a guide, questions will be asked to assess medical health status at each timepoint. These questions ask the participant(s) to rate their current health from poor to excellent and any changes in health since last checkpoint on a scale from much worse now to much better now. Number of falls, fractures, urinary tract infections, hospitalizations, healthcare visits, and emergency room visits will also be collected. For hospitalizations, healthcare visits, and emergency room visits, purpose of each will be collected. Medications will be collected including name, frequency, and dose. This information will be gathered at each checkpoint and compared for changes between timepoints but also between baseline and 12-month post enrollment.

• Change in bladder function between 5 timepoints using the Modified International SCI Lower Urinary Tract Function Basic Data setbaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  Modified International SCI Lower Urinary Tract Function Basic Data set is created by the International Spinal Cord Society to standardize the collection information on the lower urinary tract in daily clinical practice. This is not a scored outcome, and is instead a set of standardized questions. Questions examine how the bladder is emptied, average number of emptying, incontinence, medication usage, and surgical procedures related to bladder. Any changes in these answers over the course of the 12-month study will be recorded and analyzed.

• Change in bowel function between 5 timepoints using the Modified International SCI Bowel Function Basic Data setbaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  Modified International SCI Bowel Function Basic Data set is created by the International Spinal Cord Society to standardize the collection information on bowel function in daily practice. This is not a scored outcome, and is instead a set of standardized questions. Data collected includes any surgical procedures on the gastrointestinal tract, defecation method, average time to defecate, frequency of defecation, incontinence, tools/medications utilized to help manage bowel, and abdominal pain. Any changes in these answers over the course of the 12-month study will be recorded and analyzed.

• Changes in pain between 5 timepoints in study measured by questions from SCI Model Systems Form IIbaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  Pain intensity on a scale of 0-10 with 0 meaning no pain and 10 meaning severe pain, location of pain, description of pain (including options of shooting, constant, burning, tingling, among others) and pain's interference in normal work rated from not at all to extreme interference will be examined . These questions are based off questions from the SCI Model Systems form II which standardizes how we collect data on this topic. Any changes between baseline and any time point (1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment) will be recorded and analyzed

• Changes in spasticity from baseline to 4 other timepoints in study measured by Penn Spasm Frequency Scalebaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  Penn Spasm Frequency Scale is a self-report measure used to assess a patient's perception of spasticity frequency and severity. This scale has excellent internal consistency. Participants will be asked to rate their frequency of spasms on a scale of 0 (no spasms) to 4 (occurring more than 10 times per hour) and the spasm severity on a scale of 1 (mild) to 3 (severe). Any changes between baseline and any time point (1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment) will be recorded and analyzed.

• Change in quality of life assessed by the SCI Model Systems form II SCI-QOL and Satisfaction with Life scale from baseline to 4 other time points during studybaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  Quality of life will be assessed by questions from the SCI Model Systems Form II SCI-QOL Resilience short form, which asks 8 questions each rated from never to always. The satisfaction with life scale, also from which the SCI model Systems Form II, asks 5 questions where the participant(s) rates how much they agree or disagree with each statement. Total scores will be calculated for each scale, where in both scales, lower total scores correlate to lower QOL. Any changes between baseline and other measurement time points will be collected and analyzed.

• Change in mental health measured by general anxiety disorder (GAD-7) between baseline and 4 other data collection points over 12 monthsbaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  The GAD-7 is recommended by National Institute of Neurologic Disorders and Stroke Spinal Cord Injury Common Data Elements (NINDS SCI CDE) and used by the spinal cord injury (SCI) Model Systems, the GAD-7 assesses the anxiety of our participants with SCI. Consists of seven questions assessing how often the subject has been bothered by these items over the last 2 weeks, each scaled from 0 (not at all sure) to 3 (nearly every day). A total score of 5 is classified as mild anxiety, 10 is classified as moderate anxiety, and 15 is classified as severe anxiety. This measure has high sensitivity and specificity. It will be taken at baseline and 4 other study timepoints and changes between each assessment will be analyzed.

• Change in participation between baseline and 4 other study timepoints measured by the Craig Handicap Assessment And Reporting Technique (CHART)baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  The Craig Handicap Assessment And Reporting Technique (CHART) is administered through long form document. Subscales for physical independence, cognitive independence, mobility, occupation, social integration, and economic self sufficiency are scored independently. Each subscale is scored out of 100, which indicates no handicap in that section. Lower scores indicate greater handicap in that section. Any changes in subscale scores between baseline and 4 other time points will be analyzed.

• Compare healthcare expenditure from 12 months prior to exoskeleton initiation (baseline) and the year following exoskeleton acquisition by examining medical and billing recordsretrospective analysis of 12 months prior to exoskeleton acquisition, 12 months following completion of training on exoskeleton device

  Medical and Billing records for a total of 24 months (12 months prior to exoskeleton acquisition and the 12 months following completion of exoskeleton training) will be collected for each subject. Total healthcare expenditure costs will be compared between the two 12-month periods. Cost of each healthcare visit, emergency room visit, and hospital admission will be calculated. Medication cost per refill and supply costs (example: catheters) will be calculated and compared year over year. Costs will also be broken down into subcategories including hospitalizations, wound-related, bowel/bladder related, medication, etc.

• Change in participant satisfaction regarding use of exoskeletonbaseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

  Both written and interview questions will be posed to the participant to assess their impression regarding their Indego usage. Questions will assess if participant has had any issues with their Indego, are they happy with the number sessions they are using their Indego and the length of each session, what activities the participant is using the Indego for, the biggest reason for not using the Indego more often and for longer, and how the participant perceives their use compared to the last checkpoint. These answers will be qualitative and recorded at five checkpoints during the study.

• Frequency of adverse events (AEs) and serious adverse events (SAEs) throughout 12 month studyThrough study completion, 1 year

  AEs and SAEs will be tracked throughout the 12 months of the study. An adverse event form will be filled out for each AE or SAE which will include a description of the event, the action taken (medications, procedure, etc), duration of the event, if it was related to the Indego and/or the study protocol, and classification of the event. Number of events will be calculated throughout the study and reported on.