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Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal

Sponsor: University of Michigan • ClinicalTrials.gov ID: NCT07673328

Registry updated: 2026-09-30

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Description

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.

Interventions

Modular powered orthosis (Device)
This study will investigate modular, lower-limb, powered orthoses that fit to user-specific weakened joints and control force/torque in a manner that enhances voluntary motion in broad patient populations. The central hypothesis is that high-torque, low-inertia motor systems controlled with energetic objectives will enable modular powered orthoses to partially assist the joints. High-torque electric motors combined with minimal transmissions can be freely rotated (i.e., backdriven) by human joints, allowing the use of an emerging torque control method called energy shaping to reduce the perceived weight/inertia of the body during any motion. By mounting these modular actuators to commercial orthoses, this technology will be easily prescribed/configured by clinicians.

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

Conditions

Lower-limb Orthoses Osteoarthritic Knee Pain Osteoarthritis (OA) of the Knee

Locations

Rehab Lab — Ann Arbor, Michigan, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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