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

Phantom Neuro Inc.

Status: Enrolling

Conditions: Upper Limb Amputation Below Elbow

Treatments: Device: Cutaneous Prosthesis Control System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07071584

PN02

Details and patient eligibility

About

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.

Full description

The goal of this study is to evaluate the functional performance of the Phantom X prosthesis control system using a non-invasive version of its 32-electrode sensor array. All other components, including the Fusion Port, will be in their final clinical form factor, consistent with those used in future implantable configurations. The study will take place during a single, in-clinic session. Informed consent will be obtained either remotely prior to the visit or at the start of the session. Participants will undergo an initial EMG screening to determine signal suitability. Those with insufficient signal quality will be excluded. Eligible participants will be fitted with a universal socket, prosthesis, and the Phantom X system. Accelerometers will be placed on both limbs for movement tracking. Participants will practice a predefined set of gestures, followed by system calibration. Two validated functional assessments, Assessment of Capacity for Myoelectric Control (ACMC) and Targeted Box and Blocks Test (tBBT), will be conducted under two conditions: with the participant's baseline setup (if applicable) and with Phantom X. The testing order will be randomized. Participants will complete a user satisfaction questionnaire and NASA Task Load Index instrument to measure intuitiveness of Phantom X system before exiting the study.

Enrollment: 25 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Device: Cutaneous Prosthesis Control System