EMG-Based Hand-Wrist Control: Study B Mirrored (PSICON-B)
30. desember 2020 oppdatert 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
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Tidlig fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Massachusetts
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Holliston, Massachusetts, Forente stater, 01746
- Liberating Technologies, Inc
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Worcester, Massachusetts, Forente stater, 01609
- Worcester Polytechnic Institute
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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).
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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.
Andre navn:
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Eksperimentell: 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.
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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EMG-Force Models
Tidsramme: 1 day visit
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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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. juni 2017
Primær fullføring (Faktiske)
24. august 2020
Studiet fullført (Faktiske)
24. august 2020
Datoer for studieregistrering
Først innsendt
28. desember 2020
Først innsendt som oppfylte QC-kriteriene
30. desember 2020
Først lagt ut (Faktiske)
5. januar 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. januar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. desember 2020
Sist bekreftet
1. desember 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 124039
- IRB-17-155 (Annen identifikator: Worcester Polytechnic Institute)
- 5R42HD076519-03 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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