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Adaptivt hofteeksoskeleton til forbedring af slagtilfælde

5. juni 2026 opdateret af: Georgia Institute of Technology

Drevet hofteeksoskelet til slagtilfældeoverlevere med gangbesvær

Dette arbejde vil fokusere på nye algoritmer til roboteksoskeletter og afprøvning af disse i forsøg med mennesker. Personer, der tidligere har haft et slagtilfælde, vil gå, mens de bærer et roboteksoskelet på et specialiseret løbebånd. Undersøgelsen vil sammenligne ydeevnen af ​​den avancerede algoritme med ikke at bruge enheden for at bestemme den kliniske fordel.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Fokus for dette arbejde er et foreslået nyt system med kunstig intelligens (AI) til selvtilpasning af kontrolpolitikken i drevne eksoskeletoner for at hjælpe med implementeringssystemer, der tilpasser sig individuel patientgang. Efterforskerne antager, at ganghastigheden vil forbedres med brugen af ​​det selvtilpassede kontrolsystem. Personer efter slagtilfælde har en bred vifte af mobilitetsudfordringer, herunder asymmetrisk gang, væsentligt nedsat SSWS og nedsat stabilitet, og har derfor i høj grad svækket den samlede mobilitetsuafhængighed i samfundet. Efterforskerne forventer, at den foreslåede nye controller, der er i stand til at tilpasse til sådanne variable og asymmetriske gangmønstre, vil have betydelige fordele i retning af at øge samfundets uafhængighed og mobilitet for patienter efter slagtilfælde. 12 patienter efter et slagtilfælde vil være tilpasset hoftens eksoskelet og fortsætte med at gå med varierende hastigheder og hældninger på et Motek CAREN-system, mens efterforskerne måler selvvalgt ganghastighed. Det selvadaptive system vil blive sammenlignet direkte med en kontrolpolitik, der er bedst i gennemsnit (ikke-adaptiv) såvel som med en 'standard of care'-baseline. Denne baseline vil være gang uden eksoskelet plus eventuelle klinisk ordinerede passive ortoser. Efterforskerne forventer, at det selvadaptive system lærer den kontrolpolitik, der bedst matcher patientens gangmønstre, og dermed giver fordele i ganghastigheden.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30332
        • Exoskeleton and Prosthetic Intelligent Controls Lab

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

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Tidligere slagtilfælde med en læges godkendelse til sikkert at udføre de eksperimentelle aktiviteter.
  • Slagtilfældet skal være indtruffet mindst 6 måneder før undersøgelsens involvering.
  • I alderen 18-85 år.
  • Score højere end 17 på mini-mental state eksamen (MMSE).
  • Kan sidde ustøttet i minimum 30 sekunder.
  • Kan følge en 3-trins kommando.
  • Skal kunne gå uden støtte (en skinne efter behov er tilladt), med en ganghastighed på mindst 0,4 m/s (begrænset ambulatorisk hastighed i lokalsamfundet).
  • Skal kunne gå i mindst 6 minutter.
  • Skal være villig og i stand til at deltage i et 1-4 timers eksperiment, med pauser påkrævet regelmæssigt og efter behov.
  • Skal kunne forflytte sig (sidde-til-stå og stå-til-siddende) uden ekstern støtte (armlænsstøtte tilladt).
  • Skal kunne ambulere over små skråninger (3 grader) og få trin (6 trin).

Ekskluderingskriterier:

  • Tab af følelse i benene, en komplet rygmarvsskade, historie med hjernerystelse inden for de sidste 6 måneder, historie med alvorlige kardiovaskulære tilstande, alvorlig gigt eller ortopædiske problemer, der ville begrænse fuld deltagelse i undersøgelsen.
  • Diagnose af andre neurologiske lidelser såsom Parkinsons sygdom, amyotrofisk lateral sklerose (ALS), multipel sklerose (MS), demens, historie med hovedtraume, som ikke er fuldt løst (pr. deltagerrapport), amputation af underekstremiteter, ikke-helende sår i en underekstremitet, nyredialyse eller sluttilstandsleversygdom, juridisk blindhed eller alvorlig synsnedsættelse.
  • Brug af en pacemaker eller have metalimplantater i hovedregionen eller medicin, der sænker anfaldstærsklerne.
  • Til sidst, hvis du deltager i en anden klinisk undersøgelse og/eller din fysiske tilstand er begrænset til at udføre forskellige opgaver, vil du efter Principal Investigator (PI's opfattelse) sandsynligvis påvirke undersøgelsesresultatet eller forvirre resultaterne, vil du blive udelukket fra Studiet.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Hip Exoskeleton for Stroke Gait Assistance
This study will be conducted on a sample population of stroke subjects (single arm). Subjects will be tested with the hip exoskeleton and baseline.
Enhed: Hip exoskeleton
The intervention is an experimental robotic hip exoskeleton in a powered state providing assistance to the user that has been previously developed by the team. It is used to improve walking gait performance.
Andet: Baseline
The intervention will serve as a baseline where participants will be asked to perform the tasks without wearing a hip exoskeleton.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Temporal Convolutional Network (TCN) Model Performance (Joint Moment Accuracy)
Tidsramme: 5 Days
This outcome represents the error with which the deep learning model embedded into our hip exoskeleton's microprocessor predicts hip joint moments in stroke patients. Specifically, the coefficient of determination (R²) is computed between the predicted hip joint moments and the ground truth measurements. Ground truth measurements are obtained from a laboratory-grade force plate system and inverse dynamics calculations. For these measures, higher R² values (closer to 1.0) indicate better correlation between predicted and actual hip joint moments. This metric provides a comprehensive assessment of the exoskeleton's ability to accurately estimate hip joint moments in stroke patients during tasks, with improved outcomes representing better assistive capabilities for the user.
5 Days
Metabolic Cost for Level Ground Walking
Tidsramme: 5 days
Metabolic energy expenditure will be quantified using an indirect calorimetry system (Parvo Medics, UT) that measures oxygen consumption (VO₂) and carbon dioxide production (VCO₂) during experimental tasks. Measurements will be collected from each participant during a 5-minute baseline standing period followed by level ground walking trials under three conditions: without the exoskeleton, with the exoskeleton in a powered state, and with the exoskeleton in an unpowered state. Metabolic cost will be calculated from respiratory gas exchange data using standard equations for energy expenditure.
5 days
Biological Joint Work - Level Walking
Tidsramme: 5 days
Mechanical work performed by the lower limb joints during level walking will be quantified through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during level walking.
5 days
Biological Joint Work - Incline Walking
Tidsramme: 5 days
Mechanical work performed by the lower limb joints will be quantified during incline walking through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the incline walking.
5 days
Biological Joint Work - Stair Ascent
Tidsramme: 5 days
Mechanical work performed by the lower limb joints will be quantified during stair ascent through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the stair ascent task.
5 days
Biological Joint Work - Sit to Stand
Tidsramme: 5 days
Mechanical work performed by the lower limb joints will be quantified during sit to stand through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the sit to stand task.
5 days
Biological Joint Work - go and Grab
Tidsramme: 5 days
Mechanical work performed by the lower limb joints will be quantified during a go and grab task through biomechanical analysis of motion capture data. In the go and grab task, participants take several steps, lean forward, and pick up a weighted object from a low surface just above ground level. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the go and grab task.
5 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
10 Meter Walk Test (Self-selected)
Tidsramme: 5 days
This will be measured as the participant walks a distance of 10 meters across a gait mat at their self-selected (or comfortable) walking speed. This measure will be recorded in seconds with lower values indicating faster speed and higher values indicating slower speeds. Self-selected walking speed is highly correlated with functional ability and dependence.
5 days
The Timed up and go (TUG)
Tidsramme: 5 days
This will be measured as the time it takes a participant to rise from a chair, walk three meters at a self-selected pace, turn, walk back to the chair and sit down. The total time taken will be measured in seconds with longer times indicating poorer physical performance. This test assesses functional mobility and dynamic balance.
5 days
6 Minute Walk Test
Tidsramme: 5 days
This is a measurement of endurance and functional ability that assesses the participants ability to walk a distance over a time period of 6 minutes. It is measured in distance with greater distances indicating improved levels of endurance and functional ability.
5 days
Modified Stroke Impact Scale
Tidsramme: 5 days
The Modified Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item. Scores are transformed to a 0-100 scale, with 0 indicating the poorest perceived health status and 100 indicating the best, across domains of disability and health-related quality of life. Higher scores are indicative of improved quality of life.
5 days
Modified Activities-specific Balance Confidence
Tidsramme: 5 days
The modified activities specific balance confidence is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Confidence is rated for various activities on a scale from 0% to 100% for each activity, with 0% indicative of no confidence and 100% indicative of complete confidence. Scores reflect balance confidence with higher scores indicative of improved balance confidence.
5 days
Fast Self-selected Walking Speed
Tidsramme: 5 days
This will be measured as the participant walks on a treadmill at their fastest and safest walking speed. This measure will be recorded in meters/seconds with higher values indicating faster speed and lower values indicating slower speeds.
5 days

Samarbejdspartnere og efterforskere

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

Sponsor

Georgia Institute of Technology

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

  • Ledende efterforsker: Aaron Young, Ph.D., Georgia Institute of Technology

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)

21. maj 2025

Primær færdiggørelse (Faktiske)

29. august 2025

Studieafslutning (Faktiske)

29. august 2025

Datoer for studieregistrering

Først indsendt

8. september 2022

Først indsendt, der opfyldte QC-kriterier

8. september 2022

Først opslået (Faktiske)

13. september 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H18182
  • R03HD097740 (U.S. NIH-bevilling/kontrakt)
  • DP2HD111709 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

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