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EMG-Based Hand-Wrist Control: Study B Mirrored (PSICON-B)

30 december 2020 uppdaterad av: Liberating Technologies, Inc.

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

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

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

20

Fas

  • Tidig fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Massachusetts
      • Holliston, Massachusetts, Förenta staterna, 01746
        • Liberating Technologies, Inc
      • Worcester, Massachusetts, Förenta staterna, 01609
        • Worcester Polytechnic Institute

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Study B: Limb-Absent Subject
Ten unilateral transradial limb-absent subjects will each participate in one, half-day experimental session. Subjects will be seated and prepared in test apparatus seat (16 electrodes on the affected side, hand-wrist on the able side secured to load cells). Subjects will complete the 1-DoF and 2-DoF "dynamic" (force-varying) contractions (40-s duration, 0.75 Hz bandlimited, uniform random target). With 2 DoF contraction trials, hand Opn-Cls will always be one of the dimensions. The subject will then be released from the cuff and their able side not further involved in the experiment. The force feedback triangle cursor on the computer screen will be deleted such that only the target remains. Subjects will then repeat 1-DoF and 2-DoF trials in which the affected side attempts to produce hand-wrist effort that mimic movement of the target (with no feedback provided).
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.
Andra namn:
  • load cell
  • electrode array
Experimentell: Study B: Able-bodied Subjects
Ten able-bodied subjects, the electrodes will be mounted on the dominant arm for the EMG-force and EMG-target tracking trials. In addition, the non-dominant arm will also be constrained and measured in a second load cell. This load cell will not be used for feedback during the experiment, but will compare (RMS error, off-line) the dominant vs. non-dominant forces. For EMG-target tracking, the dominant hand will remain in the wrist cuff (to prevent flailing during contractions), with the screen feedback disabled. These subjects will repeat the trials with the electrodes moved to the non-dominant side. EMG-force tracking will be repeated using mirrored contractions. The three training methods (EMG-force ipsilateral, EMG-force contralateral mirrored, EMG-target on the dominant side) will be contrasted to help understand the source of errors when training with limb-absent subjects.
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.
Andra namn:
  • load cell
  • electrode array

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
EMG-Force Models
Tidsram: 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.

1 day visit

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 juni 2017

Primärt slutförande (Faktisk)

24 augusti 2020

Avslutad studie (Faktisk)

24 augusti 2020

Studieregistreringsdatum

Först inskickad

28 december 2020

Först inskickad som uppfyllde QC-kriterierna

30 december 2020

Första postat (Faktisk)

5 januari 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 januari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 december 2020

Senast verifierad

1 december 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 124039
  • IRB-17-155 (Annan identifierare: Worcester Polytechnic Institute)
  • 5R42HD076519-03 (U.S.S. NIH-anslag/kontrakt)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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