- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04692571
EMG-Based Hand-Wrist Control: Study B Mirrored (PSICON-B)
EMG-Based Hand-Wrist Control: Study B: Comparison of Contralateral (Mirrored) EMG-
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Prima fase 1
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Holliston, Massachusetts, Stati Uniti, 01746
- Liberating Technologies, Inc
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Worcester, Massachusetts, Stati Uniti, 01609
- Worcester Polytechnic Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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EMG-Force Models
Lasso di tempo: 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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Collaboratori e investigatori
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 124039
- IRB-17-155 (Altro identificatore: Worcester Polytechnic Institute)
- 5R42HD076519-03 (Sovvenzione/contratto NIH degli Stati Uniti)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su PSICON Measurement Apparatus
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Columbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Albert...Non ancora reclutamentoResistenza all'insulina | Stato prediabetico | Sovrappeso e obesità | Malattia del fegato grasso non alcolicaStati Uniti