Teleoperation Experimental Comparison With Able-bodied Subjects

NCT05048394 | Completed Results FDA Device

• 2 other identifiers: 377394R41EB032723
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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. In a randomized order, the subjects will perform functional tasks evaluating dexterity and assistance with prolonged gross motor movement using each experimental condition. Then, a direct comparison can be made across subjects for the semi-autonomous control algorithm and the standard of care myoelectric system used in the TASKA prosthetic hand.

Conditions

Amputation; Traumatic, Arm, Upper

Outcome Measures

Primary Outcomes (1)

• Transfer Success Rate in a Fragile Box and Blocks Task

  The participant is instructed to transfer a fragile, ball-like object that breaks at 8 Newtons of force over a 10-centimeter high barrier as many times as possible in a 2-minute period. A broken or dropped object is considered an unsuccessful transfer. The number of successful and attempted transfers is recorded. This task is modeled after the Box-and-Blocks Test and has been used to validate fine dexterity of myoelectric upper limb prostheses.

  Day 1 (1 hour)

Secondary Outcomes (1)

• Ball Drops in a Holding Task

  Day 1 (1 hour)

Study Arms (2)

Standard-of-care then Semi-autonomous myoelectric control

EXPERIMENTAL

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

Device: Semi-autonomous myoelectric control algorithm; Device: Standard-of-care myoelectric control algorithm

Semi-autonomous then Standard-of-care myoelectric control

EXPERIMENTAL

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

Device: Semi-autonomous myoelectric control algorithm; Device: Standard-of-care myoelectric control algorithm

Interventions

Semi-autonomous myoelectric control algorithm DEVICE

The semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.

Semi-autonomous then Standard-of-care myoelectric control; Standard-of-care then Semi-autonomous myoelectric control

Standard-of-care myoelectric control algorithm DEVICE

The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.

Semi-autonomous then Standard-of-care myoelectric control; Standard-of-care then Semi-autonomous myoelectric control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able-bodied subject
• Fluent in English
• Age of 18 years or greater

You may not qualify if:

• 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

Sponsors & Collaborators

• Point Designs: lead
• University of Colorado, Boulder: collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Results Point of Contact

• Title: Becca Connolly
• Organization: Point Designs

becca@pointdesigns.com

720-600-4753

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: March 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 18, 2024
• Results First Posted: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)