Clinical trial NCT06222398: Exoskeleton Use With In Home Functional Activities
Official title: The Observation of Exoskeleton Use With In Home Functional Activities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paraplegia
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population for this study is current exoskeleton users.

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).

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

Exclusion Criteria:

* Does not speak English
* \<18 years of age
* Does not clearly meet inclusion criteria
* Has not been cleared by manufacturer for independent exoskeleton use

Primary outcomes:
measure: Reintegration to Normal Living Index - Modified for Exoskeleton
timeFrame: baseline results will be collected same day as the home visit, same assessment will be repeated virtually at 1, 3, 6, 9, and 12 months
measure: Brief Pain Inventory (BPI)
timeFrame: baseline results will be collected same day as the home visit, same assessment will be repeated virtually at 1, 3, 6, 9, and 12 months
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: baseline results will be collected same day as the home visit, same assessment will be repeated virtually at 1, 3, 6, 9, and 12 months
Secondary outcomes:
measure: Journal Entries
timeFrame: check journal monthly up to 12 months
Other outcomes:
Locations:
city: Mesa
country: United States
facility: A. T. Still University
state: Arizona
Study officials:
affiliation: A. T. Still University
name: Sue Dahl-Popolizio, DBH
role: PRINCIPAL_INVESTIGATOR
References: