EMG-Based Hand-Wrist Control: Study B Mirrored

Amputation Clinical Trial

— PSICON-B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692571
• Other study ID #: 124039
• Secondary ID: IRB-17-1555R42HD
• Status: Completed
• Phase: Early Phase 1
• Start date: June 29, 2017
• Est. completion date: August 24, 2020

Study information

• Verified date: December 2020
• Source: Liberating Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 24, 2020
• Est. primary completion date: August 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Amputation, Congenital
• Amputation, Traumatic
• Amputation; Traumatic, Hand
• Prosthesis User

Intervention

Device:
• PSICON Measurement Apparatus
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.

Locations

Country	Name	City	State
United States	Liberating Technologies, Inc	Holliston	Massachusetts
United States	Worcester Polytechnic Institute	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Liberating Technologies, Inc.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Worcester Polytechnic Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EMG-Force Models	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