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OpenTrials
Completed

NCT Number: NCT05048394

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.

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Key information

Conditions

Amputation; Traumatic, Arm, Upper

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Transfer Success Rate in a Fragile Box and Blocks Task

    Time frame: Day 1 (1 hour)

    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.

Secondary outcomes

  1. Ball Drops in a Holding Task

    Time frame: Day 1 (1 hour)

    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.

Sponsors and collaborators

Lead sponsor

Point Designs

Industry

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • University of Colorado, Boulder

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 17, 2021
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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