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Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis

2. oktober 2026 opdateret af: Liberating Technologies, Inc.

Evaluation of Functional Performance of Persons With Limb Differences to Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis

This study is focused on optimizing methods for controlling upper-limb myoelectric prosthetic arms. If you are enrolled in this study you would be expected to visit one of the research sites for approximately 5 in-lab visits lasting about 4 hours. These visits are expected to happen within a 5-week period but may take longer depending on scheduling availability. During these visits you will be completing basic tasks similar to your everyday actions using a prosthetic arm that is provided for you.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
    • Massachusetts
      • Holliston, Massachusetts, Forenede Stater, 01746

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Aged 18 years or older
  • Unilateral transradial level limb difference
  • Current or past user of myo-electric controlled prostheses
  • Six months or more post-amputation
  • Have adequate limb length such that a wrist rotation device can fit in the check socket
  • Have adequate limb length and diameter such that at least 9 channels of electrodes fit without cross pairing
  • Well-fitting socket as determined by a Socket-Comfort Score of 6 or above
  • Capable of wearing and operating a prosthesis with a wrist rotator and multi-articulating hand
  • Capable of understanding and following multi-step instructions and completing the tasks as described
  • English speaking

Exclusion Criteria:

  • Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
  • Cognitive impairment that would adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
  • Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.
  • Pregnant participants as risk to pregnant individuals, embryos, or fetuses are not understood.

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: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sequence 1

Each arm will test all 4 conditions but in a different order from each other.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Eksperimentel: Sequence 2

Each arm will test all 4 conditions but in a different order from each other.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Eksperimentel: Sequence 3

Each arm will test all 4 conditions but in a different order from each other.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Eksperimentel: Sequence 4

Each arm will test all 4 conditions but in a different order from each other.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ACMC
Tidsramme: Through study completion, an average of 1 month, 1 time at each 4 site visits.

The participant will complete a daily task (such as packing a suitcase) using their prosthetic arm. A study occupational therapist will score the participants ability along different metrics.

Through study completion, an average of 1 month, 1 time at each 4 site visits.

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Todd Farrell, PhD, Liberating Technologies, Inc.

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)

5. december 2025

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

23. september 2026

Først indsendt, der opfyldte QC-kriterier

23. september 2026

Først opslået (Faktiske)

30. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E03209.1a
  • W81XWH2210431 (Andet bevillings-/finansieringsnummer: U.S. Army Medical Research Acquisition Activity)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Deidentified outcomes results for participants such as ACMC, clothespin relocation task, and virtual EMG measures.

IPD-delingstidsramme

Data will be shared by June 2029 and available indefinitely.

IPD-delingsadgangskriterier

Anyone will be able to access all the shared IPD on a public data repository such as FigShare or ICPSR.

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 .

Abonner