Investigation of Motorized Lower-limb Prostheses
7. května 2026 aktualizováno: Northern Arizona University
The goal of this clinical trial is to learn if a motorized prosthesis can improve mobility in individuals with amputation. The main question it aims to answer is:
- Does motorized prosthesis improve ambulation speed, balance, control, or efficiency when performing everyday activities?
- What problems arise when using a motorized prosthesis? Researchers will compare mobility of the participants when using and not using the motorized prosthesis to see if mobility and/or function improves.
Participants will perform various activities with and without the motorized prosthesis including:
- Walking at a mild incline/decline (0°-15°) on treadmill or over-ground
- Ascending or descending stairs
- Stand to sit and sit to stand transitions
- All terrain walking over ground
- Turning
- Any combination of the above-mentioned activities
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
Participants will perform ambulation activities (see list below) while using their prescribed prosthesis or the motorized prosthesis in conjunction with their prescribed passive prosthesis. Each ambulation activity will be tested in four different conditions:
- Ambulation with their personal (take home) device. This condition acts as a baseline to which the ambulation with the motorized prosthesis can be compared.
- Ambulation with the motorized prosthesis in the "off" configuration (i.e., no power is applied to the motor). This condition demonstrates the impact of the device when it is unpowered.
- Ambulation with the motorized prosthesis in the "transparent" configuration (i.e., minimal power is applied to the motor, such that the device behaves as a free hinge). This condition demonstrates the impact of the device when it behaves as a free hinge, similar to the participants personal device.
- Ambulation with the motorized prosthesis in the "powered" configuration (i.e., substantial electrical power is applied to the motor to replicate the function of the biological joint). This condition assesses the impact of the motorized prosthesis to improve ambulation of the participant.
Trials will take place over-ground and/or on a treadmill. Participants will walk for up to 40 minutes. Frequent breaks will be provided between trials and conditions to avoid fatigue and a maximum of 15 minutes of continuous walking will take place between breaks. When deemed necessary by the research staff or participant, crutches, canes, walkers, an overhead support system, or other ambulation or safety aid will be used to minimize the risk of a severe fall.
List of ambulation activities
- Walking at a mild incline/decline (0°-15°) on treadmill or over-ground
- Ascending or descending stairs
- Stand to sit and sit to stand transitions
- All terrain walking over ground
- Turning
- Any combination of the above-mentioned activities
The above conditions will be assessed using motion capture techniques in the laboratory environment which will include measures of metabolic energy consumption and muscle activity.
All terrain walking over ground will take place on campus and include Engineering, Business, and Learning resource Center buildings, the north and south quads, and campus walkways and urban trails. During all terrain walking, the participant will be attended by research personnel that will monitor subject safety.
Typ studie
Intervenční
Zápis (Odhadovaný)
20
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Dante A Archangeli, PhD
- Telefonní číslo: 928-421-3563
- E-mail: dante.archangeli@nau.edu
Studijní místa
-
-
Arizona
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Flagstaff, Arizona, Spojené státy, 86001
- Northern Arizona University
-
Kontakt:
- Dante A Archangeli, PhD
- Telefonní číslo: 928-421-3563
- E-mail: dante.archangeli@nau.edu
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
Inclusion Criteria:
- Individuals age 18 to 85 with or without lower-limb amputation
- Able to understand and follow simple directions in English based on ability to provide verbal consent
- Able to walk at least 30 feet with or without a walking aid
- Able to safely fit into a device configuration and tolerate assistance
- Individuals with lower-limb amputation must receive physician approval to participate in the study.
Exclusion Criteria:
- Any neurological, musculoskeletal (other than lower-limb amputation) or cardiorespiratory injury, health condition (including pregnancy), or diagnosis that would affect the ability to walk as directed for short periods of time.
- Participant or caregiver report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.
- Subject mass greater than the engineered limit of the device (90 kg or 198 lbs) Note: No exclusions will be made on the basis of race, gender or ethnic background.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Experimental Group
Trials will take place over-ground and/or on a treadmill. Participants will ambulate for up to 40 minutes. Frequent breaks will be provided between trials and conditions to avoid fatigue and a maximum of 15 minutes of continuous ambulation will take place between breaks. When deemed necessary by the research staff or participant, crutches, canes, walkers, an overhead support system, or other ambulation or safety aid will be used to minimize the risk of a severe fall. List of ambulation activities will include no more than
The above activities will be performed with the passive prosthesis and the motorized prosthesis in the "off", "transparent", and "powered" configurations. |
The participant will perform the study protocol with their "take home" prosthesis and/or another suitable passive prosthesis.
Ostatní jména:
The motorized prosthesis is an experimental device.
The device is constructed from plastic and metal.
It has motors, sensors, and electronic systems to control the prosthesis to mimic the behavior of a biological joint.
The device is determined non-significant risk by the sponsor's Institutional Review Board.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Joint position
Časové okno: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
|
Motion capture measurements will be taken to calculate joint position (degrees) of the ankle, knee, hip, and torso.
Participant measurements will be averaged per condition to generate a participant average.
Participant averages will be pooled to determine an average per condition.
|
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
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Joint Velocity
Časové okno: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
|
Motion capture will be used to record joint velocity (deg/s) of the ankle, knee, hip, and torso.
Participant measurements will be averaged per condition to generate a participant average.
Participant averages will be pooled to determine an average per condition.
|
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
|
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Ground reaction force
Časové okno: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
|
The force a participant exerts on the ground (Newtons) will be measured using a force plate.
Participant measurements will be averaged per condition to generate a participant average.
Participant averages will be pooled to determine an average per condition.
|
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
|
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Muscle Electric Potential
Časové okno: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
|
Muscle electric potential will be measured using skin mounted electrodes (surface electromyography) and reported in volts.
Participant measurements will be averaged per condition to generate a participant average.
Participant averages will be pooled to determine an average per condition.
|
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
|
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Gas uptake and exchange
Časové okno: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
|
Oxygen consumption and CO2 production will be measured in L/s.
Participant measurements will be averaged per condition to generate a participant average.
Participant averages will be pooled to determine an average per condition.
|
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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User Perception
Časové okno: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
|
User perception of the device will be assessed using NASA TLX survey.
Participants will assess the device on a scale of 1-10 based on a questionnaire.
Participant measurements will be averaged per condition to generate a participant average.
Participant averages will be pooled to determine an average per condition.
|
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
16. dubna 2026
Primární dokončení (Odhadovaný)
15. března 2029
Dokončení studie (Odhadovaný)
15. března 2029
Termíny zápisu do studia
První předloženo
4. března 2026
První předloženo, které splnilo kritéria kontroly kvality
7. května 2026
První zveřejněno (Aktuální)
13. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
13. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
7. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2403974-1
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NEROZHODNÝ
Popis plánu IPD
Uncertain if will publish in ICMJE journal
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
produkt vyrobený a vyvážený z USA
Ne
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