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

Enrolling by invitation

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT07030322

Run by

Ekso Bionics

People needed

5

Starts

2025-08-04

Expected to finish

2027-09-01

Last updated by the study team

2025-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Ekso Bionics, Inc. — San Rafael, California, United States

Full record on ClinicalTrials.gov

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