Not provided
Not provided
Not provided
Not provided
The study was stopped because of recruitment challenges and sponsor's decision to pivot to a new study outside the US
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Atlas Ambulatory Surgery Center | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutaneous Prosthesis Control System | Device | Prosthesis control system using a multi-electrode cutaneous sensor array |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of prosthesis control with Phantom X system | Participant satisfaction in using the Phantom X control system will be collected using a questionnaire | Through study completion, average of 1 day |
| Intuitiveness of prosthesis control using Phantom X system |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elad Levy, MD | Atlas Ambulatory Surgery Center, Buffalo, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlas Ambulatory Surgery Center | Buffalo | New York | 14221 | United States | ||
| Phantom Neuro Inc. Operational Headquarters |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Intuitiveness of prosthesis control with Phantom X control system will be evaluated using NASA-Task Load Index instrument (NASA-TLX) |
| Through study completion, average of 1 day |
| Austin |
| Texas |
| 78701 |
| United States |