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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Craig M Kelly
- Telefonní číslo: 508-893-6363
- E-mail: craig.kelly@liberatingtech.com
Studijní místa
-
-
Illinois
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Chicago, Illinois, Spojené státy, 60611
- Nábor
- Shirley Ryan AbilityLab
-
Kontakt:
- Craig M Kelly
- Telefonní číslo: 508-893-6363
- E-mail: craig.kelly@liberatingtech.com
-
-
Massachusetts
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Holliston, Massachusetts, Spojené státy, 01746
- Nábor
- Liberating Technologies, Inc. (LTI)
-
Kontakt:
- Craig M Kelly
- Telefonní číslo: 508-893-6363
- E-mail: craig.kelly@liberatingtech.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
|
Experimentální: 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. |
|
Experimentální: 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. |
|
Experimentální: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
ACMC
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Todd Farrell, PhD, Liberating Technologies, Inc.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- E03209.1a
- W81XWH2210431 (Jiné číslo grantu/financování: U.S. Army Medical Research Acquisition Activity)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Deidentified outcomes results for participants such as ACMC, clothespin relocation task, and virtual EMG measures.
Časový rámec sdílení IPD
Data will be shared by June 2029 and available indefinitely.
Kritéria přístupu pro sdílení IPD
Anyone will be able to access all the shared IPD on a public data repository such as FigShare or ICPSR.
Informace o lécích a zařízeních, studijní dokumenty
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