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ENROLLING BY INVITATION
NCT07030322

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

Sponsor: Ekso Bionics

View on ClinicalTrials.gov

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. 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 Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

5

Start Date

2025-08-04

Completion Date

2027-09

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

DEVICE

Overground Robotic Exoskeleton

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.

Locations (1)

Ekso Bionics, Inc.

San Rafael, California, United States