Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Emily Klinkman
- Telefonszám: 734-763-1156
- E-mail: emilykk@umich.edu
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Robert Gregg
- Telefonszám: 734-763-1156
- E-mail: rdgregg@umich.edu
Tanulmányi helyek
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Michigan
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Ann Arbor, Michigan, Egyesült Államok, 48109
- Toborzás
- Rehab Lab
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Kapcsolatba lépni:
- Emily Klinkman
- Telefonszám: 734-763-1156
- E-mail: emilykk@umich.edu
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Kutatásvezető:
- Robert Gregg
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egyéb
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Exoskeleton
Experimental: Exoskeleton Participants in this arm of the study will perform various tasks while wearing the modular powered orthosis |
Ez a tanulmány olyan moduláris, alsó végtagi, motoros ortéziseket vizsgál, amelyek illeszkednek a felhasználó által meghatározott legyengült ízületekhez, és olyan módon szabályozzák az erőt/nyomatékot, amely szélesebb betegpopulációban javítja az akaratlagos mozgást.
A központi hipotézis az, hogy a nagy nyomatékú, alacsony tehetetlenségi nyomatékú, energetikai objektívekkel vezérelt motorrendszerek lehetővé teszik, hogy a moduláris meghajtású ortézisek részben segítsék az ízületeket.
A minimális áttétellel kombinált, nagy nyomatékú villanymotorokat az emberi ízületek szabadon forgathatják (azaz visszahajthatók), lehetővé téve az energiaalakításnak nevezett, kialakulóban lévő nyomatékszabályozási módszer alkalmazását, amellyel csökkenthető a test észlelt súlya/tehetetlensége bármilyen mozgás során.
Ha ezeket a moduláris működtetőket kereskedelmi ortézisekre szerelik, ezt a technológiát a klinikusok könnyen előírhatják/konfigurálhatják.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Muscle effort
Időkeret: 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
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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10-meter walk test
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- HUM00201957_Period2
- R01EB031166 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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