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Udvikling af en realtidscontroller til estimering af gangpræstation ved brug af en bilateral ankelskeletudvidelse

3. november 2026 opdateret af: University of Nebraska

Controllerudvikling til at muliggøre individualiseret assistance i robotiske ankelskeletter

This study is developing and testing a new controller for a robotic ankle exoskeleton (Biomotum) that can adjust itself in real time to better support people while they walk. The system learns how each person moves and automatically changes the amount and timing of assistance to make walking feel easier and more efficient. By using information from the person wearing the device, the exoskeleton can quickly find the level of support that works best for them. The long-term goal is to create personalized walking assistance that can help people with mobility limitations move more comfortably and with less effort.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This project aims to develop and test a real-time adaptive controller for a robotic ankle exoskeleton (Biomotum) that personalizes assistance to each user by minimizing metabolic cost and optimizing muscle activation patterns during walking. Using human-in-the-loop optimization and advanced musculoskeletal modeling, the controller will dynamically adjust torque magnitude and timing to achieve optimal performance more quickly than current methods.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

6

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68108
        • Rekruttering
        • Biomechanics Research Building, University of Nebraska at Omaha
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Farah Fallahtafti, PhD
        • Underforsker:
          • Arash Gonabadi, PhD
        • Underforsker:
          • Sara Myers, PhD

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

19 år til 35 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • able to walk independently on a treadmill for 10 minutes,
  • free of neurological, cardiovascular, pulmonary, or musculoskeletal conditions that limit walking and exercising,
  • no current lower extremity pain or injury,
  • able to wear an exoskeleton and safety harness, can provide informed consent

Exclusion Criteria:

  • history of neurological disease that affected gait or balance,
  • current or recent lower extremity musculoskeletal injury or surgery,
  • chronic lower extremity pain during walking,
  • inability to participate in moderate-intensity exercise,
  • require an assistive device for walking,
  • any metabolic or systemic diseases that may be exacerbated by exercise

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single-Arm Study of a Personalized Robotic Ankle Exoskeleton Controller

This arm employs a within-subject design with two methods of estimating metabolic cost versus the gold standard measure of metabolic cost, wherein a single participant is subjected to two distinct measurements. This design allows for a direct comparison of the effects of each method (i.e., estimation versus gold standard) within the same individual, minimizing intersubject variability and enhancing the statistical power of the analysis.

This intervention uses a robotic ankle exoskeleton equipped with a real-time adaptive controller that adjusts plantarflexion torque based on each participant's walking mechanics. Unlike standard exoskeleton controllers that use fixed or pre-programmed assistance levels, this system employs human-in-the-loop optimization to continuously update torque magnitude and timing during treadmill walking. The controller integrates metabolic estimations, kinematic data, and musculoskeletal modeling to identify individualized assistance patterns that reduce walking effort and improve muscle activation efficiency. Participants complete multiple walking trials while the controller automatically modifies assistance to determine the optimal personalized settings.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Successful Real-Time Operation of the Robotic Ankle Exoskeleton Controller
Tidsramme: through study completion, an average of 1 year

Device feasibility will be evaluated by the successful real-time operation of the robotic ankle exoskeleton and adaptive controller during treadmill walking. Feasibility is defined as the controller's ability to continuously generate, update, and apply assistive torque in real time based on incoming biomechanical and physiological data without system failure, interruption, or safety-related termination. Successful operation will be confirmed by continuous controller function and synchronized data acquisition across walking trials.

through study completion, an average of 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Net Metabolic Rate During Exoskeleton-Assisted Walking Measured by Indirect Calorimetry
Tidsramme: through study completion, an average of 1 year

Net oxygen consumption (VO₂) and carbon dioxide production (VCO₂) will be measured during treadmill walking using indirect calorimetry (Cosmed K5, Cosmed USA Inc., Chicago, IL). Metabolic rate will be calculated using standard equations during steady-state walking conditions. Measurements will be collected at regular intervals to characterize metabolic demand under different exoskeleton assistance configurations.

through study completion, an average of 1 year
Estimated Metabolic Rate Derived From Joint-Space Musculoskeletal Modeling
Tidsramme: through study completion, an average of 1 year

Estimated metabolic rate will be derived from joint-space musculoskeletal models using kinematic and kinetic data collected during treadmill walking. Model-based estimates will be computed on a stride-by-stride basis to provide an indirect estimate of metabolic demand that can be compared with direct measurements from indirect calorimetry.

through study completion, an average of 1 year
Estimated Lower-Limb Muscle Activation Derived From Joint-Space Musculoskeletal Modeling
Tidsramme: through study completion, an average of 1 year

Lower-limb muscle activation patterns will be estimated using joint-space musculoskeletal models based on motion capture and ground reaction force data collected during treadmill walking. Estimated muscle activation values will be computed on a stride-by-stride basis to characterize neuromuscular engagement during exoskeleton-assisted gait.

through study completion, an average of 1 year
Lower-Limb Muscle Activation Measured by Surface Electromyography During Walking
Tidsramme: through study completion, an average of 1 year

Muscle activation of lower-limb muscles (e.g., tibialis anterior, gastrocnemius medialis, gastrocnemius lateralis, soleus) will be measured during treadmill walking using surface electromyography (Delsys). EMG signals will be collected continuously and processed to quantify muscle activation patterns during exoskeleton-assisted gait.

through study completion, an average of 1 year
During treadmill walking trials conducted at a single study visit
Tidsramme: through study completion, an average of 1 year

Controller parameter convergence will be assessed during human-in-the-loop optimization trials by evaluating changes in controller gain and timing parameters across successive walking bouts. Convergence is defined as stabilization of controller parameters within a predefined range during the optimization process.

through study completion, an average of 1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Farah Fallahtafti, PhD, Department of Biomechanics, University of Nebraska at Omaha

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)

15. august 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

5. december 2025

Først indsendt, der opfyldte QC-kriterier

30. januar 2026

Først opslået (Faktiske)

6. februar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. december 2025

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 0587-25-FB
  • 55136 (Andet bevillings-/finansieringsnummer: Nebraska Research Initiative)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

IPD will not be shared because direct measurements are only taken for baseline measurements that the modeling software will be using. The scripts and code used will be shared through opensource, but that does not include subject data.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .