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Assessment of Gesture Accuracy of a Prosthesis Control System

Assessment of Gesture Accuracy for a Multi-electrode EMG Sensor Array Based Prosthesis Control System

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06446037
Acronym
ASCENT
Enrollment
11
Registered
2024-06-06
Start date
2024-08-13
Completion date
2025-04-18
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Limb Amputation Below Elbow (Injury)

Keywords

Prosthesis, Upper limb amputee

Brief summary

The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.

Detailed description

The study will characterize the performance of Phantom X system and associated algorithms in decoding EMG signals for various hand gesture control. The EMG signals will be sensed using a non-invasive multi-electrode array applied to subjects' forearms.

Interventions

DEVICENon-invasive EMG band instrumentation

The sensed EMG signals from the subjects will be decoded by Phantom X algorithm and used to drive various gestures in a desk-mounted hand prosthesis

Sponsors

Phantom Neuro Inc.
Lead SponsorINDUSTRY

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
Yes

Inclusion criteria

1. Individuals 21 years in age and older 2. Individuals with amputation of one or both arms at transradial level (applies to amputees only) 3. Ability to follow study directions 4. Willingness and ability to sign Informed Consent

Exclusion criteria

1. Individuals with previously diagnosed muscle pathologies 2. Individuals with impaired muscle function and/or impaired ability to perform normal hand movements (normal participants) or ability to perform normal phantom hand movements (amputees) 3. Individuals with transhumeral or higher amputation of both arms (applies to amputees only) 4. Cognitively impaired to follow study instructions 5. Allergies to skin adhesive materials necessary for cutaneous electrode placement 6. Excessive hair growth on arms and inability to shave off the hair for electrode placement 7. Pregnant woman 8. Arms or residual limbs with insufficient diameter to accommodate the wearing of two cutaneous sensor arrays 9. Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study

Design outcomes

Primary

MeasureTime frameDescription
Gesture accuracyAcute visit (at most 3 hours)Percentage of hand gestures accurately decoded by Phantom X algorithm

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026