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Investigation of Motorized Lower-limb Prostheses

7. Mai 2026 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: Passive prosthesis
The participant will perform the study protocol with their "take home" prosthesis and/or another suitable passive prosthesis.
Andere Namen:
  • Kontrolle
  • Grundlinie
  • take home prosthesis
Gerät: 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.
Andere Namen:
  • powered prosthesis

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Joint position
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
User Perception
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Northern Arizona University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

16. April 2026

Primärer Abschluss (Geschätzt)

15. März 2029

Studienabschluss (Geschätzt)

15. März 2029

Studienanmeldedaten

Zuerst eingereicht

4. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2026

Zuerst gepostet (Tatsächlich)

13. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2403974-1

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

Uncertain if will publish in ICMJE journal

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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