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TerminatedNCT06222398Updated Jan 22, 2026

Exoskeleton Use With In Home Functional Activities

An observational study in Paraplegia, sponsored by A.T. Still University of Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by A.T. Still University of Health Sciences · Observational

Why this study was terminated
We have finished all data collection for phase I and are not ready to start phase II
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 64 studies in Paraplegia with a site in United States — 17 open to participants now, 18 under way, 2 of them phase 3. Paraplegia · United States.

Enrollment
8th of 10
12 · median 58
Started
2024
with 1 other
Observational
10 of 64
2 open now
Registered
53rd of 64
by date

Among the 64 studies in Paraplegia with a site in United States, this one is the 8th largest by enrollment of the 10 observational ones that give a count, is one of 2 that started in 2024, is one of 10 observational ones, and was the 53rd registered.

Paraplegia

151 studies on the registry are indexed under Paraplegia; 36 are open to participants now.

Browse Paraplegia studies →

Open to participants now

17 of the 64 studies in Paraplegia with a site in United States are open now. Recruiting first, the newest first:

12 more — sign in →

All 17 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 32 Paraplegia studies recruiting now, 15 (47%) set no upper age limit and 14 (44%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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.

Read the 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).

03

Conditions studied

  • Paraplegia

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The population for this study is current exoskeleton users.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Device: Exoskeleton

Interventions

  • DeviceExoskeleton

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

06

What researchers measure

Primary outcomes

  1. Reintegration to Normal Living Index - Modified for Exoskeleton

    Assesses quantitatively the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities. This assessment has been modified from wheelchair level to exoskeleton level. The Reintegration to Normal Living Index has 9 Likert-style items. Each item is accompanied by verbal label choices with phrases reflecting how important the situation described is to the patient as it relates to using the exoskeleton. It allows the patients to determine the extent to which the statement in question applies to their specific situation.

    Time frame: 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

  2. Brief Pain Inventory (BPI)

    The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. A higher score on the BPI indicates more severe pain. Scores can range from 0-10. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.

    Time frame: 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

  3. Canadian Occupational Performance Measure (COPM)

    The COPM assesses an individual's perceived occupational performance in the areas of self-care, productivity, and leisure. The COPM identifies 5 functional tasks the patient wants to improve, and rates their performance and satisfaction in their performance. Tasks are scored on a 1-10 scale (1-low; 10-high) for each item, then averaged over the 5 areas for an overall score. A higher score indicates better performance.

    Time frame: 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

  1. Journal Entries

    Participants will keep a daily journal/log for at least one month to keep track of how often they use the exoskeleton to do daily tasks, and to track their thoughts about using the exoskeleton in this way

    Time frame: check journal monthly up to 12 months

07

Study locations

1 site
  • A. T. Still University
    Mesa, Arizona 85206, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2024 to primary completion in Dec 2025, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2023
First posted
Jan 24, 2024
StartActual
Feb 10, 2024
Primary completionActual
Dec 28, 2025
CompletionActual
Dec 28, 2025
Last update
Jan 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06222398
Lead sponsor
A.T. Still University of Health Sciences
Responsible party
Sponsor
First posted
Jan 24, 2024
Start date
Feb 10, 2024
Primary completion
Dec 28, 2025
Completion
Dec 28, 2025
Last update
Jan 22, 2026

Study contacts

Sue Dahl-Popolizio, DBH
principal investigator · A. T. Still University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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