Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Emily Klinkman
- 電話番号：734-763-1156
- メール：emilykk@umich.edu
研究連絡先のバックアップ
- 名前：Robert Gregg
- 電話番号：734-763-1156
- メール：rdgregg@umich.edu
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- 募集
- Rehab Lab
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コンタクト：
- Emily Klinkman
- 電話番号：734-763-1156
- メール：emilykk@umich.edu
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主任研究者：
- Robert Gregg
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Exoskeleton
Experimental: Exoskeleton Participants in this arm of the study will perform various tasks while wearing the modular powered orthosis |
この研究では、ユーザー特有の弱くなった関節にフィットし、幅広い患者集団の随意運動を強化する方法で力/トルクを制御する、モジュール式の下肢電動装具を調査します。
中心的な仮説は、エネルギー目標によって制御される高トルク、低慣性のモーター システムにより、モジュール式動力装具が関節を部分的に補助できるようになるというものです。
最小限のトランスミッションと組み合わされた高トルクの電気モーターは、人間の関節によって自由に回転させる (つまり、バックドライブする) ことができ、エネルギーシェイピングと呼ばれる新しいトルク制御方法を使用して、あらゆる動作中に知覚される体の重量/慣性を軽減することができます。
これらのモジュール式アクチュエータを市販の装具に取り付けることで、この技術は臨床医によって簡単に処方/設定されるようになります。
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Muscle effort
時間枠：Baseline and through study completion, an average of 2 months
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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).
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Baseline and through study completion, an average of 2 months
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Joint moment load
時間枠：Baseline and through study completion, an average of 2 months
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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).
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Baseline and through study completion, an average of 2 months
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Pain score
時間枠：Baseline and through study completion, an average of 2 months
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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. |
Baseline and through study completion, an average of 2 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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10-meter walk test
時間枠：Baseline and through study completion, an average of 2 months
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A 10-meter walk test on an overground walkway will assess self-selected walking speed across three conditions: no orthosis, conventional orthosis, and powered orthosis at their preferred assistance level.
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Baseline and through study completion, an average of 2 months
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Joint range of motion
時間枠：Baseline and through study completion, an average of 2 months
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Joint range of motion for each task will be recorded using optical motion capture and averaged over cycle and repetitions.
Motion capture data will be recorded during study visits and used to calculate joint angle, which will then be averaged over gait cycles and activity repetitions to get a range of motion value.
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Baseline and through study completion, an average of 2 months
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Joint compressive forces
時間枠：Baseline and through study completion, an average of 2 months
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In Aim 3, joint compressive forces for each task will be modeled using OpenSim / inverse dynamics and
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Baseline and through study completion, an average of 2 months
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Difficulty score
時間枠：Baseline and through study completion, an average of 2 months
|
The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess perceived difficulty 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. |
Baseline and through study completion, an average of 2 months
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QUEST
時間枠：Baseline and through study completion, an average of 2 months
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We will administer the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) survey after each orthosis condition to assess comfort and satisfaction with the device. The QUEST 2.0 is a highly-validated, 12-item self-report questionnaire designed to measure how satisfied a person is with a wide range of assistive technology. It contains 12 items divided into 2 primary categories: device subscale and services subscale. Participants rate each item using a 5-point Likert scale: 1 = Not satisfied at all, 2 = Not very satisfied, 3 = More or less satisfied, 4 = Quite satisfied, 5 = Very satisfied. To calculate the final metrics, the scores of the items are summed and divided by the total number of valid responses. This yields three separate scores ranging from 1.0 to 5.0: a Device Score, a Services Score, and a Total QUEST Score. Higher scores indicate a better outcome (greater satisfaction with the technology). |
Baseline and through study completion, an average of 2 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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