Investigation of Motorized Lower-limb Prostheses

NCT07584707 | Not Yet Recruiting FDA Device

• 1 other identifier: 2403974-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ambulation With the Motorized Prosthesis in the "Off" Configuration; Ambulation With the Motorized Prosthesis in the "Powered" Condition; Ambulation With the "Take Home" or Passive Prosthesis; Ambulation With the Motorized Prosthesis in the "Transparent" Condition

Keywords

motorized prosthesis; ambulation; biomechanics; mobility; amputation

Outcome Measures

Primary Outcomes (5)

• Joint position

  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

  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

  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

  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

  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)

Secondary Outcomes (1)

• User Perception

  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)

Study Arms (1)

Experimental Group

EXPERIMENTAL

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.

Device: Passive prosthesis; Device: Motorized prosthesis

Interventions

Passive prosthesis DEVICE

The participant will perform the study protocol with their "take home" prosthesis and/or another suitable passive prosthesis.

Also known as: take home prosthesis, control, baseline

Experimental Group

Motorized prosthesis DEVICE

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.

Also known as: powered prosthesis

Experimental Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Arizona University: lead

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86001, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Dante A Archangeli, PhD

CONTACT

928-421-3563; dante.archangeli@nau.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: May 13, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): March 15, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)