NCT07673328 Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal
| NCT ID | NCT07673328 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Lower-limb Orthoses |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2025-07-18 |
| Primary Completion | 2030-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 65 participants in total. It began in 2025-07-18 with a primary completion date of 2030-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 Exclusion criteria for knee osteoarthritis participants will be: * Pregnant (self-report) * Any recent lower-extremity fracture (within 6 months) * Significant limitation on knee joint range of motion * Significant neurological (e.g., stroke) or cardiovascular disorder that may affect the ability to walk * Advised by a physician not to walk or exercise * Uncontrolled hypertension or diabetes * Use of opioids * Cognitive deficits or visual impairment 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07673328 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Lower-limb Orthoses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07673328 currently recruiting?
Yes, NCT07673328 is actively recruiting participants. Contact the research team at emilykk@umich.edu for enrollment information.
Where is the NCT07673328 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07673328 clinical trial?
NCT07673328 is sponsored by University of Michigan. The trial plans to enroll 65 participants.