Investigation of Motorized Lower-limb Prostheses

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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

Key Dates

Start date

Apr 16, 2026

Status verified

May 2026

Primary completion

Mar 15, 2029

Completion

Mar 15, 2029

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Joint position [ Time Frame: 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) ]

Central Contacts

• Dante A Archangeli, PhD
  928-421-3563
  [email protected]

Locations (1)

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