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Search / Trial NCT07030322

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

Launched by EKSO BIONICS · Jun 12, 2025

Trial Information

Current as of July 23, 2025

Enrolling by invitation

Keywords

Exoskeleton Spinal Cord Injury Sci Healthcare Spending

ClinConnect Summary

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 devic...

Gender

ALL

Eligibility criteria

  • 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

About Ekso Bionics

Ekso Bionics is a pioneering company in the field of robotic exoskeletons, dedicated to enhancing mobility and rehabilitation for individuals with physical challenges. Through innovative technology and rigorous clinical research, Ekso Bionics develops advanced robotic solutions designed to assist patients in regaining movement and improving their quality of life. The company collaborates with healthcare providers and research institutions to conduct clinical trials that assess the efficacy and safety of its products, driving forward the integration of robotic assistance in therapeutic settings. With a commitment to improving patient outcomes, Ekso Bionics is at the forefront of transforming rehabilitation practices and empowering individuals to achieve greater independence.

Locations

San Rafael, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported