Investigation of Motorized Lower-limb Prostheses
7 mai 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Dante A Archangeli, PhD
- Numéro de téléphone: 928-421-3563
- E-mail: dante.archangeli@nau.edu
Lieux d'étude
-
-
Arizona
-
Flagstaff, Arizona, États-Unis, 86001
- Northern Arizona University
-
Contact:
- Dante A Archangeli, PhD
- Numéro de téléphone: 928-421-3563
- E-mail: dante.archangeli@nau.edu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Joint position
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
User Perception
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
16 avril 2026
Achèvement primaire (Estimé)
15 mars 2029
Achèvement de l'étude (Estimé)
15 mars 2029
Dates d'inscription aux études
Première soumission
4 mars 2026
Première soumission répondant aux critères de contrôle qualité
7 mai 2026
Première publication (Réel)
13 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2403974-1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime IPD
Uncertain if will publish in ICMJE journal
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Non
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