Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal (NCT07673328) | Clinical Trial Compass
RecruitingNot Applicable
Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal
United States65 participantsStarted 2025-07-18
Plain-language summary
The overall goal of this project is to establish a novel design and control paradigm for modular, partial-assist powered orthoses (exoskeletons) to enhance voluntary lower-limb motion and manage pain in broad patient populations. Building upon a previous study period that addressed weakness from advanced age or muscle fatigue, this current period extends the technology to novel powered unloader orthoses designed to manage knee osteoarthritis (OA) pain. The investigators hypothesize that by providing 15-30% of biological joint torque, these motorized devices can reduce muscular contributions to painful loads on the joint's surfaces during activities of daily living (ADLs). The project aims to develop a task-agnostic, neural network-based controller and establish the feasibility of reducing knee pain and muscle effort in individuals with multi-compartment knee osteoarthritis.
Who can participate
Age range
18 Years – 85 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:
Inclusion criteria for able-bodied, young participants will be:
* Aged between 18 to 65 years
* Weigh less than 300 lbs (due to challenges in bracing heavier participants)
* BMI \< 40 (due to challenges in bracing heavier participants)
Inclusion criteria for knee osteoarthritis participants will be:
* Aged between 30 to 85 years
* Medical diagnosis of patellofemoral and tibiofemoral osteoarthritis
* Patient reported pain ≥ 4 out of 10 during activities of daily life (to avoid floor effects)
* Weigh less than 300 lbs (due to challenges in bracing heavier participants)
* BMI \< 40 (due to challenges in bracing heavier participants)
* Ability to walk 6 minutes without assistance from a person (may use walking aid)
* Ability to ascend/descend ramps and stairs with or without the use of handrails
Exclusion Criteria:
Exclusion criteria for able-bodied, young adult participants will be:
* Pregnant (self-report)
* Any significant neuromuscular or musculoskeletal disorder that would interfere with the study
* Unable to walk for 20 minutes
* History of any cardiovascular, vestibular, or visual diseases and/or impairments that may interfere with the study
* Cognitive deficits that would impair their ability to give informed consent or impair their ability to follow simple instructions during the experiments. Cognitive deficits will be determined by a Mini-Mental State Examination (MMSE) score of \<22.
* Adults with a known allergy to medical grade tape
Exclus…
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
Muscle effort
Timeframe: Baseline and through study completion, an average of 2 months
2
Joint moment load
Timeframe: Baseline and through study completion, an average of 2 months
3
Pain score
Timeframe: Baseline and through study completion, an average of 2 months