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.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Craig M Kelly
- Numer telefonu: 508-893-6363
- E-mail: craig.kelly@liberatingtech.com
Lokalizacje studiów
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60611
- Rekrutacyjny
- Shirley Ryan AbilityLab
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Kontakt:
- Craig M Kelly
- Numer telefonu: 508-893-6363
- E-mail: craig.kelly@liberatingtech.com
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Massachusetts
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Holliston, Massachusetts, Stany Zjednoczone, 01746
- Rekrutacyjny
- Liberating Technologies, Inc. (LTI)
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Kontakt:
- Craig M Kelly
- Numer telefonu: 508-893-6363
- E-mail: craig.kelly@liberatingtech.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Eksperymentalny: 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. |
|
Eksperymentalny: 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. |
|
Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
ACMC
Ramy czasowe: Through study completion, an average of 1 month, 1 time at each 4 site visits.
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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.
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Todd Farrell, PhD, Liberating Technologies, Inc.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- E03209.1a
- W81XWH2210431 (Inny numer grantu/finansowania: U.S. Army Medical Research Acquisition Activity)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Deidentified outcomes results for participants such as ACMC, clothespin relocation task, and virtual EMG measures.
Ramy czasowe udostępniania IPD
Data will be shared by June 2029 and available indefinitely.
Kryteria dostępu do udostępniania IPD
Anyone will be able to access all the shared IPD on a public data repository such as FigShare or ICPSR.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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