Exoskeleton Use With In Home Functional Activities

NCT ID: NCT06222398

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2025-12-28

Brief Summary

The purpose of this study is to observe current exoskeleton users in their home environment to determine the activities of daily living (ADLs) they are able to complete, and to identify the minor adaptations to the home environment that will improve the exoskeleton user's potential for increased independence. This is a pilot study to fine-tune the methods and to determine the feasibility of doing this study on a larger scale.

Detailed Description

The exoskeleton is a wearable robotic device that provides the ability to walk to those with spinal cord injury, or other neurological injuries who have lost their ability to walk and are wheelchair dependent. There are multiple health benefits to regaining the ability to adopt a standing posture, even for brief periods of time, including issues that are common with chronic wheelchair use such as pressure ulcers, bowel and bladder disorders, spasticity, and pain. Although there is a large amount of literature regarding people walking with the assistance of an exoskeleton, there is a dearth in the literature regarding use of an exoskeleton to complete normal activities of daily living (ADL) in the home environment. To date, no studies have been done assessing what the patient can do in their home environment while wearing the exoskeleton. The information that exists on the topic has been obtained primarily through interviews and surveys asking the patient to contemplate how to improve the exoskeleton, but patients have not been asked to complete ADLs wearing the exoskeleton, and their ability to do ADLs while using the exoskeleton has not been observed. As the ability to complete ADLs in standing would increase the usability of the exoskeleton, which would allow patients to wear them more frequently, and potentially for longer periods of time, this is a critical research gap. There is potential for physiological and psychological benefit to exoskeleton users with this increased use. It is possible that minor alterations in their environment could provide the opportunity for exoskeleton users to be independent, or nearly independent in some ADLs if their environment is set up for them. To determine these two points further research is indicated.

Specifically, for this study, patients who currently wear an exoskeleton will be observed in their home environment to determine the activities of daily living (ADLs) they are able to complete, and to identify the minor adaptations to the home environment that will improve the exoskeleton user's potential for increased independence. There will be one home visit where the environment for the patient will be adjusted as necessary (e.g. put necessary items on the counter or vanity so the patient can make a sandwich standing at the counter, or brush their teeth standing at the vanity). This minor adaptation provides easier access to items associated with activities of daily living. During this first visit, patients will complete several outcomes measures. The same outcome measures will be completed remotely, by phone or video call, by patients again at 1, 3, 6, 9, and 12 months post-initial home visit to determine if patients experience any change in the outcome measures (pain, quality of life, self-perception of task performance).

Conditions

Paraplegia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exoskeleton Users

This study includes patients who are current exoskeleton users. Exoskeleton users will engage in normal activities of daily living (ADLs) that they currently perform at wheelchair level while using the exoskeleton. Researchers will observe the ADLs the exoskeleton users are and are not able to complete while using their exoskeleton.

Exoskeleton

Intervention Type: DEVICE

The study will include one group of patients who are current exoskeleton users.

Interventions

Exoskeleton

The study will include one group of patients who are current exoskeleton users.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• At least 18 years old
• English speaking
• Trained and approved/credentialed by exoskeleton manufacturer to use the device independently according to FDA approved activities

• Has not been cleared by manufacturer for independent exoskeleton use

Exclusion Criteria

• Does not speak English
• <18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

A.T. Still University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sue Dahl-Popolizio, DBH

Role: PRINCIPAL_INVESTIGATOR

A. T. Still University

Locations

A. T. Still University

Mesa, Arizona, United States

Countries

United States

Other Identifiers

2023-196

Identifier Type: -

Identifier Source: org_study_id