CompletedNot Applicable

Evaluating Mobility Interventions in the Real World

United States20 participantsStarted 2021-09-03

Plain-language summary

This study is intended to test the comparative biomechanical benefits of different lower-limb prostheses and orthoses using data collected over extended periods of everyday life using wearable sensors. Investigators seek to improve physical health, functional activity level, independence, workforce participation, and mental health in participants with lower limb amputation and other lower-limb impairments. Investigators seek to study the similarities and differences in participants' movement using prostheses and orthoses with different technological features or designs. Study team also seek to develop technologies that enhance the methods for using wearable sensor technology to perform this type of study. Participants with lower-limb amputation, participants who use lower limb orthoses, and participants with drop-foot (including a specific group with Multiple Sclerosis).

Who can participate

Age range

18 Years – 75 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: Target Populations: * Participants with amputation must have used a prosthesis for more than 6 months, and wear it for at least 8 hours per day. * Participants must be more than 6 months past their most recent surgery (if any). * Participants must be free of musculoskeletal and cardiovascular conditions that would limit their ability to safely complete testing. * Participants should consider themselves in good health; be able to wear their prostheses or orthoses all day long; be able to perform all of their activities of daily living (ADL) with their prostheses or orthoses as appropriate; have a comfortably fitting functional prosthesis (if applicable) that does not cause any skin problems; and have a stable residual limb (or impaired limb). * Participants may use a narrow-base cane (single point, narrow tripod base, etc.) as an ambulatory aid but not a small-base quad cane or walker. * Participants must be able to walk with their prostheses or orthoses for 30 minutes (total) and stand for 30 minutes (total), in individual bouts of at least 6 minutes, without becoming fatigued, feeling dizzy, having chest pain or shortness of breath, or experiencing claudication symptoms. * Participants involved in running tests must be able to run for 30 minutes (total) in bouts of at least 6 minutes, without becoming fatigued, feeling dizzy, having chest pain, or experiencing claudication symptoms. * Participants must have no known cognitive disability. * Participants …

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

Minimum Foot Clearance With Different Prostheses

Timeframe: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Minimum Foot Clearance With Different Orthoses

Timeframe: Baseline, 10 days, and 20 days for Orthotic interventions

Trial details

NCT IDNCT04275973

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-01

Results submitted2025-07-31

View on ClinicalTrials.gov More Lower Limb Amputation trials