Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Muscle effort
研究概览
简要总结
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.
详细描述
The overall goal of this project is to develop modular, lower-limb, powered orthoses that fit to user-specific joints and control torque in a manner that enhances voluntary motion and mitigates musculoskeletal pain. Commercial exoskeletons typically use actuation and control methods that force the human user to follow specific, rigid gait patterns. This has prevented emerging wearable robotics from effectively addressing the weakness and pain associated with mild to moderate impairments, such as knee osteoarthritis (OA). These populations require partial, task-agnostic assistance that works harmoniously with their voluntary motion rather than constraining it.
To bridge this gap, this project utilizes a quasi-direct drive actuation paradigm, a high-torque motor combined with a low-ratio transmission, integrated into conventional knee stabilizer and unloader braces. This hardware is uniquely capable of producing large output torques without causing perceptible resistance when backdriven by the human joint. To control the device across various activities of daily living (ADLs) without requiring pre-programmed trajectories, the investigators are developing a neural network-based formulation of "energy shaping" (effectively combining virtual springs, dampers, and gravity/inertia compensation) trained on multi-activity human data.
The specific objectives of this study period are to:
- Integrate the modular quasi-direct drive actuator and miniaturized electronics into both a modified knee stabilizer brace and a modified unloader knee brace.
- Implement and validate the neural network-based energy shaping controller to provide task-agnostic, biomimetic torque assistance with able-bodied subjects.
- Establish the clinical feasibility of this technology in individuals with multi-compartment knee OA.
The investigators hypothesize that the biomimetic torque assistance provided by these motorized braces will significantly reduce quadriceps effort, knee joint moment loads, and subjective pain across ADLs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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 <
- •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 <
- •Adults with a known allergy to medical grade tape
研究组 & 干预措施
Exoskeleton
Experimental: Exoskeleton
Participants in this arm of the study will perform various tasks while wearing the modular powered orthosis
干预措施: Modular powered orthosis (Device)
结局指标
主要结局
Muscle effort
时间窗: Baseline and through study completion, an average of 2 months
Muscle activity will be measured by surface EMG electrodes, and EMG sites will be averaged by flexors and extensors. For each condition (no orthosis vs. powered orthosis), signals will be normalized by their peaks during the no-orthosis condition, and then averaged over cycle, repetitions, and tasks to obtain overall muscle effort (focusing on knee extension for the powered knee orthosis, hip extension and flexion for the powered hip orthosis, and ankle plantarflexion for the powered ankle orthosis).
Joint moment load
时间窗: Baseline and through study completion, an average of 2 months
Biological torques will be estimated by subtracting the assistive torques from the total joint torques computed via inverse dynamics (using OpenSim). Biological torques will be divided into flexion and extension. For each condition (no orthosis vs. powered orthosis), signals will be normalized by their peaks during the no-orthosis condition, and then averaged over cycle, repetitions, and tasks to obtain overall joint moment load (focusing on knee extension for the powered knee orthosis, hip extension and flexion for the powered hip orthosis, and ankle plantarflexion for the powered ankle orthosis).
Pain score
时间窗: Baseline and through study completion, an average of 2 months
The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess perceived pain for a multi-activity circuit test and isolated activity tests. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). It is an extension of the WOMAC Osteoarthritis Index. A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures.
次要结局
- 10-meter walk test(Baseline and through study completion, an average of 2 months)
- Joint range of motion(Baseline and through study completion, an average of 2 months)
- Joint compressive forces(Baseline and through study completion, an average of 2 months)
- Difficulty score(Baseline and through study completion, an average of 2 months)
- QUEST(Baseline and through study completion, an average of 2 months)
研究者
Robert D Gregg
Professor, Robotics Department Director, Locomotor Control Systems Laboratory
University of Michigan