Teleoperation Experimental Comparison With Able-bodied Subjects

Amputation; Traumatic, Arm, Upper Clinical Trial

Official title:

Teleoperation Experimental Comparison With Able-bodied Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05048394
• Other study ID #: 377394
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: December 2023
• Source: Point Designs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the use of the semi-autonomous control algorithm (condition 1) with the standard of care myoelectric system used with the TASKA prosthetic hand (condition 2). Able bodied subjects will enroll in a laboratory based experimental session at the University of Colorado at Boulder. In a randomized order, subjects will be fitted with a by-pass prosthesis which enables the able-bodied subject to control the prosthetic hand using the myoelectric signals on their able limb. A TASKA prosthetic hand will be sensorized using the Point Touch technology. Then, the subjects will perform the ACMC outcome measure using each experimental condition. Trained observers will record the measure. Then, a direct comparison can be made both within subject performance and across subjects for the semi-autonomous control algorithm developed in Aim 2.1 and the standard of care myoelectric system used in the TASKA prosthetic hand.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able-bodied subject

• Fluent in English

• Age of 18 years or greater

Exclusion Criteria:

• Significant cognitive deficits as determined upon clinical evaluation

• Significant neurological deficits as determined upon clinical evaluation

• Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation

Related Conditions & MeSH terms

• Amputation, Traumatic
• Amputation; Traumatic, Arm, Upper

Intervention

Device:
• Semi-autonomous myoelectric control algorithm
The semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.
• Standard-of-care myoelectric control algorithm
The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.

Locations

Country	Name	City	State
United States	University of Colorado Boulder	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Point Designs	University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Capacity for Myoelectric Control (ACMC)	The proctor for the measure chooses an everyday activity, such as setting up a table for snacks or replanting a flower, that is relevant to the study population. As the participants perform the chosen task, a trained rater will assess their capacity for control of their myoelectric prosthesis as represented by 30 items reflecting 6 aspects of quality of myoelectric control. These 6 aspects are "the need for external support," "grip force and opening width," "coordination of both hands, "in different positions and in motion (timing)," "repetitive grip and release," and "the need for visual feedback." Each item is scored on a 4-point scale and converted into linear measures of myoelectric control using Rasch analysis methods on the ACMC website. ACMC is the only measure that has been validated for individuals with upper limb (UL) loss who use myoelectric control and has been shown to demonstrate good test-retest reliability	Day 1 (1 hour)