Investigation of Motorized Lower-limb Prostheses
7 maggio 2026 aggiornato da: 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
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
20
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Dante A Archangeli, PhD
- Numero di telefono: 928-421-3563
- Email: dante.archangeli@nau.edu
Luoghi di studio
-
-
Arizona
-
Flagstaff, Arizona, Stati Uniti, 86001
- Northern Arizona University
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Contatto:
- Dante A Archangeli, PhD
- Numero di telefono: 928-421-3563
- Email: dante.archangeli@nau.edu
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Joint position
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
User Perception
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
16 aprile 2026
Completamento primario (Stimato)
15 marzo 2029
Completamento dello studio (Stimato)
15 marzo 2029
Date di iscrizione allo studio
Primo inviato
4 marzo 2026
Primo inviato che soddisfa i criteri di controllo qualità
7 maggio 2026
Primo Inserito (Effettivo)
13 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2403974-1
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano IPD
Uncertain if will publish in ICMJE journal
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .