Evaluation of a Multi-electrode Prosthesis Control System for Real-world Tasks Performance in Individuals With Upper Limb Transradial Amputation

NCT07071584 | Withdrawn

• 1 other identifier: PN02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This study tests how well the Phantom X prosthesis control system works. The system helps control a prosthetic hand using muscle signals from the arm. You'll wear a non-invasive version for one day in the clinic. You'll practice hand movements and then do two simple tasks with both your usual prosthesis and the Phantom X system. At the end, you'll fill out short surveys about your experience.

Conditions

Upper Limb Amputation Below Elbow

Keywords

Myoelectric control; Transradial amputee; Prosthesis

Outcome Measures

Primary Outcomes (2)

• Feasibility of Phantom X Prosthesis Control System in performing activities of daily living (ADL)

  Feasibility of prosthesis control will be assessed using Assessment of Capacity of Myoelectric Control (ACMC) and while participants perform predefined ADL tasks. ACMC score ranges from 0-100, higher score suggesting better prosthesis myoelectric control.

  Through study completion, average of 1 day

• Feasibility of Phantom X Prosthesis Control System in performing repeated task requiring hand dexterity

  Feasibility of Phantom X system in performing repeated task requiring prosthetic hand's dexterity will be assessed using Targeted Box and Blocks Test (tBBT) in which participants will transfer numbered blocks from one compartment to corresponding spots in a second adjacent compartment. tBBT is scored by measuring time taken to complete block transfer from one compartment to another. Lower completion time suggests better performance.

  Through study completion, average of 1 day

Secondary Outcomes (2)

• Satisfaction of prosthesis control with Phantom X system

  Through study completion, average of 1 day

• Intuitiveness of prosthesis control using Phantom X system

  Through study completion, average of 1 day

Study Arms (1)

Participants instrumented with cutaneous version of Phantom X system using a universal socket

EXPERIMENTAL

With Phantom X system instrumented, participants will perform the following two assessments: ACMC and tBBT. They will also complete user satisfaction and NASA-TLX questionaries.

Device: Cutaneous Prosthesis Control System

Interventions

Cutaneous Prosthesis Control System DEVICE

Prosthesis control system using a multi-electrode cutaneous sensor array

Participants instrumented with cutaneous version of Phantom X system using a universal socket

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals 21 years in age and older
• Individuals with unilateral or bilateral amputation at transradial level
• Patient is willing to comply with study protocol and make required study visits
• Willingness and ability to sign Informed Consent

You may not qualify if:

• Cognitively impaired to follow study instructions
• Allergies to skin adhesive materials necessary for cutaneous electrode placement
• Excessive hair growth on arms and inability to shave off the hair for electrode placement
• Pregnant woman
• Residual limbs of insufficient diameter or length to accommodate the wearing of two cutaneous sensor arrays
• Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study

Sponsors & Collaborators

• Phantom Neuro Inc.: lead
• Atlas Ambulatory Surgery Center: collaborator

Study Sites (2)

Atlas Ambulatory Surgery Center

Buffalo, New York, 14221, United States

Location

Phantom Neuro Inc. Operational Headquarters

Austin, Texas, 78701, United States

Location

Study Officials

• Elad Levy, MD

  Atlas Ambulatory Surgery Center, Buffalo, NY

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 17, 2025
• Study Start: August 15, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-12

Locations

US (2)