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Completed

NCT Number: NCT04692571

EMG-Based Hand-Wrist Control: Study B Mirrored

Study assessing four-channel prosthesis controller, that compares contralateral (mirrored) EMG-force training to ipsilateral EMG-target training with both limb-absent and able-bodied subjects

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Key information

Conditions

Amputation Amputation, Congenital Amputation; Traumatic, Hand Prosthesis User

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Liberating Technologies, Inc, Holliston, Massachusetts, United States

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About this study

System identification models relating forearm electromyogram (EMG) signals to phantom wrist radial-ulnar deviation force, pronation-supination moment and/or hand open-close force (EMG-force) are hampered by lack of supervised force/moment output signals in limb-absent subjects. In able-bodied and unilateral transradial limb-absent subjects, we studied three alternative supervised output sources in one degree of freedom (DoF) and 2-DoF target tracking tasks: (1) bilateral tracking with force feedback from the contralateral side (non-dominant for able-bodied/ sound for limb-absent subjects) with the contralateral force as the output, (2) bilateral tracking with force feedback from the contralateral side with the target as the output, and (3) dominant/limb-absent side unilateral target tracking without feedback and the target used as the output.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Limb-absent subjects: unilateral trans-radial limb absence or amputation
  • Be capable of completing the requested contractions on the affected dominant side

Exclusion criteria

  • Past injuries to the upper limbs that would limit their ability to complete the requested contractions
  • Scars that would impede the use of surface electrodes

Treatment and study plan

PSICON Measurement Apparatus

Device

Test apparatus acquires 16 sEMG channels, measure four DoFs of force/moment at the hand-wrist [hand open-close (Opn-Cls); wrist extension-flexion (Ext-Flx), radial-ulnar deviation (Rad-Uln) and pronation-supination (Pro-Sup)]. sEMG system used 16 custom encased bipolar electrodes. A commercial LTI EMG amplifier (BE328) conditioned each EMG signal before A/D conversion on a PC. A thermoplastic hand cuff secured the wrist to a six-axis load cell (AMTI, model MC3A-100) for force/moment measurement. A separate hand-grasp one-axis load cell (Omega Engineering Inc., model LCR-150) was Velcro-secured between the fingers and the thumb, to measure power grip forces. The PC acquired and stored the sEMG and load cell data, and commanded a triangular screen target. The subject controlled a second triangular cursor. Left-right movement of the cursor was controlled by wrist Ext-Flx, up-down movement by Rad-Uln deviation, cursor rotation by Pro-Sup and cursor size by hand Opn-Cls forces.

Other names: load cell, electrode array

Primary outcomes

  1. EMG-Force Models

    Time frame: 1 day visit

    Electromyogram waveform measurements (signal amplitude, frequency) will be related to force measurements (magnitude and moment) as related to the target tracking tasks. These signal-force data will be use to generate the models.

    The specific outcome for each subject will be the RMS error measured in the tracking tasks as the difference between the generated control signal from the user versus the prompted target signal, as measured by an EMG array.

Sponsors and collaborators

Lead sponsor

Liberating Technologies, Inc.

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Worcester Polytechnic Institute

Registry information

Official study title

EMG-Based Hand-Wrist Control: Study B: Comparison of Contralateral (Mirrored) EMG-

Acronym: PSICON-B

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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