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

22. juni 2026 opdateret af: Robert D Gregg, University of Michigan
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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:

  1. Integrate the modular quasi-direct drive actuator and miniaturized electronics into both a modified knee stabilizer brace and a modified unloader knee brace.
  2. Implement and validate the neural network-based energy shaping controller to provide task-agnostic, biomimetic torque assistance with able-bodied subjects.
  3. 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

65

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Rekruttering
        • Rehab Lab
        • Kontakt:
        • Ledende efterforsker:
          • Robert Gregg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exoskeleton

Experimental: Exoskeleton

Participants in this arm of the study will perform various tasks while wearing the modular powered orthosis
Enhed: Modulær drevet ortose
Denne undersøgelse vil undersøge modulære, underekstremitetsdrevne ortoser, der passer til brugerspecifikke svækkede led og kontrollerer kraft/drejningsmoment på en måde, der forbedrer frivillig bevægelse i brede patientpopulationer. Den centrale hypotese er, at motorsystemer med højt drejningsmoment og lav inerti, styret med energimæssige mål, vil gøre det muligt for moduldrevne ortoser delvist at hjælpe leddene. Elektriske motorer med højt drejningsmoment kombineret med minimale transmissioner kan frit roteres (dvs. drives tilbage) af menneskelige led, hvilket tillader brugen af ​​en ny drejningsmomentkontrolmetode kaldet energiformning for at reducere den opfattede vægt/inerti af kroppen under enhver bevægelse. Ved at montere disse modulære aktuatorer på kommercielle ortoser, vil denne teknologi let blive ordineret/konfigureret af klinikere.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Muscle effort
Tidsramme: 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).
Baseline and through study completion, an average of 2 months
Joint moment load
Tidsramme: 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).
Baseline and through study completion, an average of 2 months
Pain score
Tidsramme: 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.
Baseline and through study completion, an average of 2 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
10-meter walk test
Tidsramme: 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.
Baseline and through study completion, an average of 2 months
Joint range of motion
Tidsramme: Baseline and through study completion, an average of 2 months
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.
Baseline and through study completion, an average of 2 months
Joint compressive forces
Tidsramme: Baseline and through study completion, an average of 2 months
In Aim 3, joint compressive forces for each task will be modeled using OpenSim / inverse dynamics and
Baseline and through study completion, an average of 2 months
Difficulty score
Tidsramme: 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
QUEST
Tidsramme: Baseline and through study completion, an average of 2 months

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Michigan

Samarbejdspartnere

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. juli 2025

Primær færdiggørelse (Anslået)

30. marts 2030

Studieafslutning (Anslået)

31. marts 2030

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HUM00201957_Period2
  • R01EB031166 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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