Health and Financial Impact on the Use of a Personal Exoskeleton in the Home and Community: a Case Study

NCT07030322 | Enrolling By Invitation FDA Device

• 1 other identifier: 1385701
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to examine the long-term use of a personal overground robotic exoskeleton in subjects with spinal cord injury. The main aims of this study include:

1. 1.Determine patterns of personal overground robotic exoskeleton use over 12 months.
2. 2.Examine the impact of personal overground robotic exoskeleton use on health outcomes over 12 months. These will include:
3. 3.Objective health - heart rate, physical activity, sleep behavior, body temperature, body-mass index, and bone density
4. 4.Medical status - rehospitalization, infection frequency, pressure injury, falls, fractures, medication (type/dose)
5. 5.Function - bowel function, bladder function, pain, spasticity, quality of life, mental health, social participation
6. 6.Determine healthcare expenditure over 12 months

Conditions

Spinal Cord Injury

Keywords

exoskeleton; spinal cord injury; SCI; healthcare spending

Outcome Measures

Primary Outcomes (15)

• Change in sessions recorded and provided by the exoskeleton device across study timepoints

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Change in time spent walking recorded and provided by the exoskeleton device across study timepoints

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Change in walking time recorded and provided by the exoskeleton device across study timepoints

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Change in usage metrics as reported by user

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Change in medical health status, assessed by interview and written questions based on the SCI Model Systems form II, between all timepoints in study

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Change in bladder function between 5 timepoints using the Modified International SCI Lower Urinary Tract Function Basic Data set

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Change in bowel function between 5 timepoints using the Modified International SCI Bowel Function Basic Data set

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Changes in pain between 5 timepoints in study measured by questions from SCI Model Systems Form II

  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

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Changes in spasticity from baseline to 4 other timepoints in study measured by Penn Spasm Frequency Scale

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• 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 study

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Change in mental health measured by general anxiety disorder (GAD-7) between baseline and 4 other data collection points over 12 months

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Change in participation between baseline and 4 other study timepoints measured by the Craig Handicap Assessment And Reporting Technique (CHART)

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Compare healthcare expenditure from 12 months prior to exoskeleton initiation (baseline) and the year following exoskeleton acquisition by examining medical and billing records

  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.

  retrospective analysis of 12 months prior to exoskeleton acquisition, 12 months following completion of training on exoskeleton device

• Change in participant satisfaction regarding use of exoskeleton

  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.

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Frequency of adverse events (AEs) and serious adverse events (SAEs) throughout 12 month study

  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.

  Through study completion, 1 year

Secondary Outcomes (7)

• Changes in heart rate measured by wearable health monitoring device from baseline to study completion

  Through study completion, 1 year

• Change in sleep behavior over the duration of the 12-months using a wearable health monitoring device

  Through study completion, 1 year

• Change in body temperature over the duration of the 12-months using a wearable health monitoring device

  Through study completion, 1 year

• Changes in body mass index (BMI) at 5 time points during the study based on self reported height and weight

  baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.

• Change in bone mineral density (BMD) will be assessed using dual-energy x-ray absorptiometry (DXA) at baseline and conclusion of the study with comparison of z scores assessed.

  baseline and 12-months post-enrollment

Study Arms (1)

Subjects with spinal cord Injury (SCI) who have a personal overground robotic exoskeleton device

Adults with a medical diagnosis of a spinal cord injury and sufficient upper extremity strength to manage approved stability aids (crutches, walker) who have access to a robotic exoskeleton device (Ekso Indego Personal) for use at home and in the community.

Device: Overground Robotic Exoskeleton

Interventions

Overground Robotic Exoskeleton DEVICE

Participants will have received training on their personal exoskeleton device prior to data collection. There is no required use dosage of the Ekso Indego Personal for this observational study.

Subjects with spinal cord Injury (SCI) who have a personal overground robotic exoskeleton device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ekso Bionics Clinical team will identify ambassadors with SCI who are interested in attaining an Indego device.

You may qualify if:

• Femur lengths from 14.5" to 19" (35.5cm to 47 cm)
• Healthy bone density
• Height from 5'1" to 6'3" (1.5 to 1.9 m)
• Seated hip width ≤ 16.6" (42.2 cm)
• Sufficient upper extremity strength to manage approved stability aids
• Weight 250 lbs or less
• Availability of a support person able to complete training and be present during all Indego sessions

You may not qualify if:

• Cognitive impairments resulting in inability to follow directions
• Colostomy bag
• Diminished standing tolerance caused by orthostatic hypotension
• Heterotopic ossification
• Hip or knee contractures greater than 10° or ankle contractures greater than 5°
• History of severe neurological injuries other than SCI (multiple sclerosis, --cerebral palsy, amyotrophic lateral sclerosis, traumatic brain injury, etc).
• Lower limb prothesis
• Poor skin integrity in areas in contact with the device
• Pregnancy
• Psychiatric conditions that may interfere with proper operation of the device
• Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores
• Severe or uncontrolled spasticity (Modified Ashworth 4)
• Spinal instability or spinal orthotics
• Uncontrolled autonomic dysreflexia
• Uncontrolled hypertension or hypotension

Sponsors & Collaborators

• Ekso Bionics: lead

Study Sites (1)

Ekso Bionics, Inc.

San Rafael, California, 94901, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 22, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)