Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Emily Klinkman
- Numer telefonu: 734-763-1156
- E-mail: emilykk@umich.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Robert Gregg
- Numer telefonu: 734-763-1156
- E-mail: rdgregg@umich.edu
Lokalizacje studiów
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- Rekrutacyjny
- Rehab Lab
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Kontakt:
- Emily Klinkman
- Numer telefonu: 734-763-1156
- E-mail: emilykk@umich.edu
-
Główny śledczy:
- Robert Gregg
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Exoskeleton
Experimental: Exoskeleton Participants in this arm of the study will perform various tasks while wearing the modular powered orthosis |
W badaniu tym zbadane zostaną modułowe, zasilane ortezy kończyn dolnych, które dopasowują się do osłabionych stawów specyficznych dla użytkownika i kontrolują siłę/moment obrotowy w sposób, który poprawia dobrowolny ruch w szerokich populacjach pacjentów.
Główną hipotezą jest to, że układy silnikowe o wysokim momencie obrotowym i niskiej bezwładności sterowane celami energetycznymi umożliwią modułowe zasilane ortezy do częściowego wspomagania stawów.
Silniki elektryczne o wysokim momencie obrotowym w połączeniu z minimalnymi przekładniami mogą być swobodnie obracane (tj. Cofane) przez ludzkie stawy, co pozwala na zastosowanie nowej metody kontroli momentu obrotowego, zwanej kształtowaniem energii, w celu zmniejszenia postrzeganej masy / bezwładności ciała podczas dowolnego ruchu.
Dzięki zamontowaniu tych siłowników modułowych w komercyjnych ortezach technologia ta będzie łatwo zalecana/konfigurowana przez klinicystów.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Muscle effort
Ramy czasowe: 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
Ramy czasowe: 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).
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Baseline and through study completion, an average of 2 months
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Pain score
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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10-meter walk test
Ramy czasowe: Baseline and through study completion, an average of 2 months
|
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HUM00201957_Period2
- R01EB031166 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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