10 Participants Needed

Exoskeleton for Paraplegia

SD
JR
Overseen ByJennifer Radziak, OTD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: A.T. Still University of Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe how individuals who already use exoskeletons manage daily activities at home. Researchers seek to identify which tasks can be accomplished with the exoskeleton and determine small modifications that could make its use easier and more independent. As a pilot study, it serves as a preliminary test to assess the feasibility of a larger study. Suitable participants are those already trained to use an exoskeleton independently for daily activities. As an unphased study, this trial offers participants the chance to contribute to pioneering research that could improve daily living for exoskeleton users.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on observing exoskeleton use at home, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that this exoskeleton is safe for users?

Research shows that exoskeletons can be safe to use, but some risks exist. Studies have found that an ill-fitting or unexpectedly moving exoskeleton can be dangerous. A poor fit might cause awkward positions, leading to shoulder or back strain.

However, proper training and adjustments can enhance safety. Ensuring a good fit and wearing protective gear are important steps to reduce risks. While these issues have been noted, the findings suggest that with the right precautions, exoskeletons can be safely used in daily activities.12345

Why are researchers excited about this trial?

Researchers are excited about using exoskeletons at home because they offer a new way for people with mobility challenges to perform everyday activities, such as cooking or cleaning, at eye level rather than wheelchair height. Unlike standard treatments that mainly rely on physical therapy and mobility aids like wheelchairs, exoskeletons provide a more dynamic support system that enables users to stand and move more naturally. This approach not only improves the user's physical capabilities but also enhances their independence and quality of life by allowing them to engage more fully in daily activities.

What evidence suggests that this exoskeleton is effective for improving independence in daily activities?

This trial will focus on participants who currently use exoskeletons. Studies have shown that exoskeletons can significantly improve movement. For example, using an active exoskeleton like HAL increased walking distance by 77.8% in a 6-minute walking test. Exoskeletons also enhance balance and simplify everyday tasks. Research indicates that these devices can reduce physical strain and fatigue, making daily activities less tiring. Overall, exoskeletons boost independence by providing extra strength and stamina.678910

Who Is on the Research Team?

SD

Sue Dahl-Popolizio, DBH

Principal Investigator

A. T. Still University

Are You a Good Fit for This Trial?

Inclusion Criteria

You can speak English.
You are trained and approved to use the exoskeleton device on your own for activities approved by the FDA.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Home Visit and Initial Assessment

Participants are observed in their home environment to determine the activities of daily living (ADLs) they can complete with the exoskeleton. The environment is adjusted as necessary, and baseline outcome measures are collected.

1 day
1 visit (in-person)

Remote Monitoring

Participants complete outcome measures remotely at 1, 3, 6, 9, and 12 months post-initial home visit to assess changes in pain, quality of life, and task performance.

12 months
5 visits (virtual)

Follow-up

Participants are monitored for long-term changes in their ability to perform ADLs and overall satisfaction with exoskeleton use.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Exoskeleton

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Exoskeleton UsersExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

A.T. Still University of Health Sciences

Lead Sponsor

Trials
22
Recruited
5,500+

Citations

Actively Controlled Exoskeletons Show Improved Function ...

On average, the active exoskeleton HAL, showed improvements of 77.8% in the 6MWT and 90.5% in the 10MWT. The passive exoskeletons on average ...

Exoskeleton Use With In Home Functional Activities

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 ...

Exoskeleton technology in nursing practice

The review focuses on the reduction of physical strain and fatigue, improved posture and body mechanics, enhanced patient care, usability and ...

Exoskeletons for Elderly Activity of Daily Living Assistance

Exoskeletons have the potential to assist the elderly in daily tasks, improve mobility and balance, and provide additional strength, endurance, ...

Exoskeleton technology in nursing practice: assessing ...

The effectiveness of exoskeletons in reducing physical strain and fatigue among nurses is supported by evidence showing decreased muscle ...

Exoskeletons: Contribution to Occupational Health and Safety

This review aims to characterize the current landscape of exoskeletons designed to promote medical care and occupational safety in industrial settings.

Exoskeletons and Occupational Health Equity

Poor fitting exoskeleton suits can cause awkward working postures and thus, increase the risk of shoulder/back fatigue or disorders [19]. Poor ...

Relevance of hazards in exoskeleton applications: a survey ...

Our results identified a list of relevant hazards for exoskeletons. Among them, misalignments and unintended device motion were perceived as key ...

Controlling safety and health challenges intrinsic in ...

This paper presents research aimed at developing insights needed to control safety risks associated with exoskeleton (wearable robot) use across three ...

Back to Basics: The Safety Benefits of Exoskeletons

Train workers in safe exoskeleton use. · Wear proper personal protective equipment (PPE). · Adjust the exoskeleton to the proper fit for the user.