Exoskeleton Use With In Home Functional Activities

NCT06222398 | Terminated FDA Device

• 1 other identifier: 2023-196
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Paraplegia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Journal Entries

  check journal monthly up to 12 months

Study Arms (1)

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

Exoskeleton DEVICE

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

Exoskeleton Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population for this study is current exoskeleton users.

You may qualify if:

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

You may not qualify if:

• Does not speak English
• \<18 years of age
• Has not been cleared by manufacturer for independent exoskeleton use

Sponsors & Collaborators

• A.T. Still University of Health Sciences: lead

Study Sites (1)

A. T. Still University

Mesa, Arizona, 85206, United States

Location

MeSH Terms

Conditions

Paraplegia

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Sue Dahl-Popolizio, DBH

  A. T. Still University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 24, 2024
• Study Start: February 10, 2024
• Primary Completion: December 28, 2025
• Study Completion: December 28, 2025
• Last Updated: January 22, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)