Teleoperation Experimental Comparison With Able-bodied Subjects

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.

Study Overview

• Status: Completed
• Conditions: Amputation; Traumatic, Arm, Upper
• Intervention / Treatment: Device: Standard-of-care myoelectric control algorithm; Device: Semi-autonomous myoelectric control algorithm

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • University of Colorado Boulder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard-of-care then Semi-autonomous myoelectric control; 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: 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.; 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.
Experimental: Semi-autonomous then Standard-of-care myoelectric control; 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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ball Drops in a Holding Task	The participant is instructed to pick up a 2-inch Styrofoam ball and hold the object above the desk or table for 2 minutes. If the ball is dropped, the participant is instructed to pick it back up. The 2-minute timer does not restart. The number of times the ball was dropped is recorded. This task has been used to validate the ability of myoelectric prostheses to assist with gross, prolonged movements.	Day 1 (1 hour)

Collaborators and Investigators

• Sponsor: Point Designs
• Collaborators: University of Colorado, Boulder; National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: 377394; R41EB032723 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No