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Adaptive Recalibration of Prosthetic Leg Neural Control System

27. oktober 2020 opdateret af: Levi Hargrove, Shirley Ryan AbilityLab
The purpose of this study is for transfemoral amputees to walk with an experimental robotic prosthesis. Electric signals will be measured from their muscles and used to help control an artificial leg. The investigators will record from sensors placed on a prosthesis and electric signals measured from muscles in the participants leg to see if the investigators can develop better computer programs to help predict subject actions and prostheses function.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The investigators propose to use a powered knee-ankle prosthesis that is not yet commercially available. The hierarchical control framework the investigators are developing will be equally applicable to any prosthetic leg that needs to be transitioned between ambulation modes, including microprocessor-controlled passive devices.

The overall objective is to develop and evaluate an adaptive framework for controlling lower limb prostheses that compensates for changes in EMG signals. When a participant walks on a lower limb prosthesis, the output of the high-level controller (or ambulation mode predictor) directly influences patterns generated by the participant. After the participant has completed the subsequent stride, a gait pattern estimator (GPE), will provide a label of what the participant actually did. This may differ from the ambulation mode predictor output if there was a misclassification. The label will then be used to update the ambulation mode predictor algorithm such that future steps are predicted with higher accuracies. Finally, the resulting system will be transferred to an embedded system and tested in real-time with transfemoral amputees and compared to a non-adaptive system.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

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
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Rehabilitation Institute of Chicago

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Amputee Subjects

Inclusion Criteria:

  • Lower Limb Amputees
  • K2/K3/K4 ambulators

Exclusion Criteria:

  • Over 250lbs body weight
  • Inactive, physically unfit
  • cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments
  • Pregnant women
  • co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)

Able-bodied Subjects:

Inclusion Criteria:

  • no injury on either lower extremity

Exclusion Criteria:

  • inactive, physically unfit
  • over 250 lbs body weight
  • 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
  • Pregnant women (status determined by self-reporting)
  • co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)

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: Evaluate a real-time adaptive neural control system
The prosthesis will be tuned, for each subject: level-ground walking, walking up and down slopes and walking up and down stairs. We anticipate that participants will visit the laboratory approximately 6-9 times over 2 months (2-3 visits for socket duplications and modifications, 2-3 visits for control system tuning, and an additional 2-3 visits for practice using the tuned system). By the end of these visits, the goal is to have a properly fitting socket and for the subjects to ambulate proficiently with the powered prosthesis. After tuning, the subjects will complete 20 ambulation circuits (level ground walking, walking up and down slopes, up and down stairs). This will provide training data for our pattern recognition control systems.
Enhed: Powered knee and ankle prosthesis
A powered knee and ankle prosthesis developed by Vanderbilt University.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decreased error rates for pattern recognition system used to predict ambulation modes
Tidsramme: Assessed at approximately 2 months and 6 months after enrollment
Pattern recognition algorithms have been used to allow seamless and automatic transitioning between ambulation modes. Classification errors result in the prosthesis predicting the wrong ambulation mode. A decrease in errors results in improved mode prediction by the prosthesis. EMG from the participant and mechanical sensor data from the prosthesis are processed with the use of a phase-based-dependent pattern recognition classification method. The data collection will yield three groups of 10 real-time trials. The investigators primary analysis will be a repeated measures ANOVA with a planned contrast between the groups. The investigators will also complete a secondary analysis using the data collected while the participants ambulated outside of the laboratory. The total number of misclassifications will be computed. This will allow the investigator to evaluate the rate at which the overall classification system adapted.
Assessed at approximately 2 months and 6 months after enrollment

Samarbejdspartnere og efterforskere

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

Sponsor

Shirley Ryan AbilityLab

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

1. januar 2015

Primær færdiggørelse (Faktiske)

1. januar 2020

Studieafslutning (Faktiske)

1. januar 2020

Datoer for studieregistrering

Først indsendt

16. januar 2015

Først indsendt, der opfyldte QC-kriterier

30. januar 2015

Først opslået (Skøn)

4. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STU00101767

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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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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