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Investigation of Motorized Lower-limb Prostheses

7 maja 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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:

  1. Ambulation with their personal (take home) device. This condition acts as a baseline to which the ambulation with the motorized prosthesis can be compared.
  2. 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.
  3. 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.
  4. 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

  1. Walking at a mild incline/decline (0°-15°) on treadmill or over-ground
  2. Ascending or descending stairs
  3. Stand to sit and sit to stand transitions
  4. All terrain walking over ground
  5. Turning
  6. 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 studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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

  1. Walking at a mild incline/decline (0°-15°) on treadmill or over-ground
  2. Ascending or descending stairs
  3. Stand to sit and sit to stand transitions
  4. All terrain walking over ground
  5. Turning
  6. Any combination of the above-mentioned activities

The above activities will be performed with the passive prosthesis and the motorized prosthesis in the "off", "transparent", and "powered" configurations.
Urządzenie: Passive prosthesis
The participant will perform the study protocol with their "take home" prosthesis and/or another suitable passive prosthesis.
Inne nazwy:
  • kontrola
  • linia bazowa
  • take home prosthesis
Urządzenie: Motorized prosthesis
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.
Inne nazwy:
  • powered prosthesis

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Joint position
Ramy czasowe: 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)
Joint Velocity
Ramy czasowe: 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)
Ground reaction force
Ramy czasowe: 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)
Muscle Electric Potential
Ramy czasowe: 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)
Gas uptake and exchange
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
User Perception
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Northern Arizona University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

16 kwietnia 2026

Zakończenie podstawowe (Szacowany)

15 marca 2029

Ukończenie studiów (Szacowany)

15 marca 2029

Daty rejestracji na studia

Pierwszy przesłany

4 marca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 maja 2026

Pierwszy wysłany (Rzeczywisty)

13 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2403974-1

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

Uncertain if will publish in ICMJE journal

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Passive prosthesis

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Warunki

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