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

Part of paid clinical trials in San Rafael, California.

Sponsor
Ekso Bionics
Study ID
NCT07030322
Status
Enrolling By Invitation

Conditions

  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
Aug 4, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
5 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Change in sessions recorded and provided by the exoskeleton device across study timepoints [ Time Frame: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ekso Bionics, Inc.San RafaelCalifornia94901-

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