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

Ekso Bionics

Status: Invitation-only

Conditions: Spinal Cord Injury

Treatments: Device: Overground Robotic Exoskeleton

Study type: Observational

Funder types: Industry

Identifiers

NCT07030322

1385701

Details and patient eligibility

About

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. Determine patterns of personal overground robotic exoskeleton use over 12 months.

2. Examine the impact of personal overground robotic exoskeleton use on health outcomes over 12 months. These will include:

   1. Objective health - heart rate, physical activity, sleep behavior, body temperature, body-mass index, and bone density
   2. Medical status - rehospitalization, infection frequency, pressure injury, falls, fractures, medication (type/dose)
   3. Function - bowel function, bladder function, pain, spasticity, quality of life, mental health, social participation

3. Determine healthcare expenditure over 12 months

Participants and their support person(s) will be trained on using a personal robotic exoskeleton in their home and community. Once they complete training, they will use the exoskeleton as they wish (ie, no requirement to use the device a certain number of times per week) and data collection will begin.

Full description

This prospective observational study will recruit and enroll individuals with SCI. These individuals will be part of a convenience sample due to employment or volunteer work with Ekso Bionics. They will be own or have access to an Indego Personal exoskeleton for home use. The parallel mixed methods design will allow for quantitative and qualitative data collected concurrently and integrated with equal consideration. Eligible individuals will be identified through work with representatives at Ekso Bionics for device acquisition and set up of training. Individuals who acquire a personal device will be screened for eligibility (criteria detailed below) and qualifying patients will be approached to participate. Upon providing consent, participants will complete quantitative and qualitative assessments over 12 months. Assessments will be conducted on five occasions: (1) baseline, (2) 1-month post-enrollment, (3) 3-months post-enrollment, (4) 6-months post-enrollment, and (5) 12-months post-enrollment. All study specific assessments will be completed by trained assessors. Quantitative and qualitative assessments will be completed by a physical therapist or other member of the research staff with necessary training. Time commitment for each participant at each assessment is 60 to 90 minutes.

Additionally, participants will be fitted for and provided at study enrollment with a wearable medical monitoring device for continuous tracking over 12-months. Study staff will provide each participant with a personal device account, to be set up using a premade study email, during enrollment. These emails will be generated utilizing a unique identifier feature which allows a single email to be suffixed with a unique identifier (e.g., study email account: "[e-mail]", participant S001 Wearable sensor account: "[e-mail]"). Each account will be linked to a research data collection platform at Ekso Bionics. Ekso Bionics will collect necessary data from the wearable sensors including: heart rate, physical activity, sleep data, stress scores, weight, and profile information. To maintain blinding of potential health data, we will use the 1st of the birth month for each participant, so activity levels based on age can still be calculated appropriately. Data from the wearable device will be retrieved from the manufacturer cloud-based storage. All data is available for export by study staff either individually or as batch data, including all de-identified participant data in one file.

No specific intervention will take place during this observational study. However, each will have access to an Ekso Indego Personal device for home and community use. The Ekso Indego Personal (Indego) is a wearable powered exoskeleton device that actively assists individuals to stand and walk; these are individuals with walking impairments resulting from lower extremity weakness or paralysis due to spinal cord injury. Unique in design, the Indego consists of five (5) snap-together components (the lumbar/hip section, right and left upper leg sections, and right and left lower leg sections). The hip component houses a rechargeable battery pack, while each upper leg component houses two motors as well as embedded sensors and controllers. The Ekso Indego Personal incorporates powered movement of both hip and knee joints, in addition to built-in ankle-foot-orthoses (AFOs) at both ankle joints, which provide ankle support and stability, and also transfers the weight of the exoskeleton to the ground. The Ekso Indego Personal requires use of a stability aid, such as a rolling walker or set of forearm crutches. Once acquired, participants will complete device training and utilize their personal Ekso Indego exoskeleton according to their individual preferences with their certified support person.

Assessments will include: brief usage survey, 1-1 focused interview on device usage, device data, objective health data captured by wearable health monitor, self-reported BMI, bone mineral density, medical status questionnaire, Modified International SCI Lower Urinary Tract Function Basic Data Set, Modified International SCI Bowl Function Basic Data Set, pain questionnaire, Penn Spasm Frequency Scale, quality of life questionnaire, General Anxiety Disorder-7, Craig Handicap Assessment And Reporting Technique, health encounters survey, 1-1 focused interview on healthcare encounters, and medical records review.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Unhealed limb or pelvic fractures
• Unresolved deep vein thrombosis
• Any condition which in the opinion of a medical doctor prevents the user from using the device

Trial design

5 participants in 1 patient group

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

Description:

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.

Treatment:

Device: Overground Robotic Exoskeleton