Study of Wearable Interventions for Improving Mobility of Individuals With Knee Osteoarthritis (NCT07652437) | Clinical Trial Compass
RecruitingNot Applicable
Study of Wearable Interventions for Improving Mobility of Individuals With Knee Osteoarthritis
United States9 participantsStarted 2025-12-15
Plain-language summary
Knee osteoarthritis (OA) affects an estimated 654 million people over age 40 world-wide. In the United States, approximately 16% of adults over the age of 40 have knee OA. Pain, activity limitations and disability are common symptoms. Exercise is widely recommended as a non-invasive, first line strategy for people with knee OA. Yet, less than 1/3 of adults with knee OA meet recommended levels of physical activity, and rates are even lower among people who are overweight. Furthermore, adherence to evidence-based structured programs is poor once the therapeutic support is removed. End stage disease is treated by total joint replacement. Under-active people with knee OA would benefit from general walking activity, even if joint replacement surgery is expected; however, walking is difficult and motivation is low. Thus, people with knee OA encounter a difficult paradox: exercise could help decrease pain and improve function but doing so can be difficult and may not always be possible. There is a tremendous need to address this situation. This is a small device-feasibility study evaluating the Dephy ExoBoot, a wearable powered exoskeleton, in individuals with knee OA. The study assesses whether the device can reliably deliver positive assistance during walking and is tolerated across walking tasks. Additional measures, including changes in knee loading and walking speed with versus without the device, are also collected.
Who can participate
Age range
21 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any gender
* 21+ years of age
* Doctor-diagnosed tibiofemoral knee osteoarthritis
* Self-report knee pain or stiffness on most days of the past month
* Self-report of difficulty walking due to at least one knee
* Self-report of restricted walking behavior (not engaging in 150 minutes of moderate walking a week) due to at least in part one knee
* Able to walk one block without the use of an assistive device (e.g. a cane or walker)
* Able to engage in a walking activity program with the wearable intervention for approximately 30 minutes using standing or sitting rests as needed
Exclusion Criteria:
* Unable to walk at least 10 minutes in the community due to an existing cardiovascular, cardiopulmonary, musculoskeletal, or neurological condition
* Planning knee, hip, ankle or back surgery within the next 6-months
* Ankle or hip osteoarthritis
* Inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, scleroderma, Lymes Disease, Lupus)
* Bilateral total knee replacements
* Use of an assistive device (e.g., walker or cane) in home or in the community
* Self-reported fall within the past 6-months that resulted in limitations in daily activities
* Lower extremity/foot peripheral neuropathy or other sensory disorders
* Diagnosed with vestibular or other balance disorder that impact walking
* Open wounds or active skin irritation on the leg shank
* Open wounds or active ulcers of either feet
* Unstable cardiovascular disease
* Unstable respirato…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants that Complete Walking Protocol with Real-time Device Assistance
Timeframe: Up to 4 sessions across 4 weeks, each lasting up to 2 days.