Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Craig M Kelly
- Telefonnummer: 508-893-6363
- E-Mail: craig.kelly@liberatingtech.com
Studienorte
-
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60611
- Rekrutierung
- Shirley Ryan AbilityLab
-
Kontakt:
- Craig M Kelly
- Telefonnummer: 508-893-6363
- E-Mail: craig.kelly@liberatingtech.com
-
-
Massachusetts
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Holliston, Massachusetts, Vereinigte Staaten, 01746
- Rekrutierung
- Liberating Technologies, Inc. (LTI)
-
Kontakt:
- Craig M Kelly
- Telefonnummer: 508-893-6363
- E-Mail: craig.kelly@liberatingtech.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
ACMC
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Todd Farrell, PhD, Liberating Technologies, Inc.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- E03209.1a
- W81XWH2210431 (Andere Zuschuss-/Finanzierungsnummer: U.S. Army Medical Research Acquisition Activity)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Deidentified outcomes results for participants such as ACMC, clothespin relocation task, and virtual EMG measures.
IPD-Sharing-Zeitrahmen
Data will be shared by June 2029 and available indefinitely.
IPD-Sharing-Zugriffskriterien
Anyone will be able to access all the shared IPD on a public data repository such as FigShare or ICPSR.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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