CompletedEarly Phase 1

Assessment of Gesture Accuracy of a Prosthesis Control System

United States11 participantsStarted 2024-08-13

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Individuals with previously diagnosed muscle pathologies
✕. 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)
✕. Individuals with transhumeral or higher amputation of both arms (applies to amputees only)
✕. 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
✕. Arms or residual limbs with insufficient diameter to accommodate the wearing of two cutaneous sensor arrays

What they're measuring

Gesture accuracy

Timeframe: Acute visit (at most 3 hours)

Trial details

NCT IDNCT06446037

SponsorPhantom Neuro Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-18

View on ClinicalTrials.gov More Upper Limb Amputation Below Elbow (Injury) trials