Upper Limb Amputation Below Elbow
Conditions
Keywords
Myoelectric control, Transradial amputee, Prosthesis
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.
Detailed 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.
Interventions
DEVICECutaneous Prosthesis Control System
Prosthesis control system using a multi-electrode cutaneous sensor array
Sponsors
Phantom Neuro Inc.
Atlas Ambulatory Surgery Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Phantom X Prosthesis Control System in performing activities of daily living (ADL) | Through study completion, average of 1 day | 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. |
| Feasibility of Phantom X Prosthesis Control System in performing repeated task requiring hand dexterity | Through study completion, average of 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of prosthesis control with Phantom X system | Through study completion, average of 1 day | Participant satisfaction in using the Phantom X control system will be collected using a questionnaire |
| Intuitiveness of prosthesis control using Phantom X system | Through study completion, average of 1 day | Intuitiveness of prosthesis control with Phantom X control system will be evaluated using NASA-Task Load Index instrument (NASA-TLX) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElad Levy, MD
Atlas Ambulatory Surgery Center, Buffalo, NY
Outcome results
None listed