Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06222398
Other study ID # 2023-196
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 10, 2024
Est. completion date February 10, 2026

Study information

Verified date February 2024
Source A.T. Still University of Health Sciences
Contact Sue Dahl-Popolizio, DBH
Phone 4802658055
Email sdahlpopolizio@atsu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date February 10, 2026
Est. primary completion date February 10, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States A. T. Still University Mesa Arizona

Sponsors (1)

Lead Sponsor Collaborator
A.T. Still University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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
Primary 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.
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
Primary 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.
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 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 check journal monthly up to 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04736849 - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury N/A
Terminated NCT00429013 - Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue. Phase 2
Completed NCT00838838 - Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis N/A
Completed NCT05563402 - "Evaluation of Usability and Safety of the Self-balancing Walking System Atalante in Patients With Multiple Sclerosis" N/A
Recruiting NCT05432999 - Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury N/A
Enrolling by invitation NCT02602639 - Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury N/A
Completed NCT00385918 - Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI) N/A
Recruiting NCT04397250 - High-intensity Interval Training for Cardiometabolic Health in Persons With Spinal Cord Injury N/A
Terminated NCT02412046 - Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics N/A
Completed NCT06169969 - Effect Of Magnetic Therapy In Bladder Dysfunction And Quality Of Life In Paraplegic Patients N/A
Recruiting NCT01474148 - A Neuroprosthesis for Seated Posture and Balance N/A
Terminated NCT03114345 - Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient N/A
Active, not recruiting NCT02600910 - Natural History of Shoulder Pathology in Manual Wheelchair Users
Completed NCT01739023 - Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Subacute SCI Phase 1
Terminated NCT01498991 - Spinal Cord Injury Leg Rehabilitation Phase 1/Phase 2
Recruiting NCT06071949 - Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis Phase 3
Recruiting NCT06072001 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis Phase 3
Completed NCT04215081 - ExoAtlet II For SCI Patients N/A
Completed NCT04110561 - Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis N/A
Completed NCT00270855 - Exercise to Reduce Obesity in Spinal Cord Injury N/A