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

NCT07030322 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2025-08-07

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury

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.

Sponsors & Collaborators

  • Ekso Bionics

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07030322 on ClinicalTrials.gov