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Teleoperation Experimental Comparison With Able-bodied Subjects

Primary Purpose

Amputation; Traumatic, Arm, Upper

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Semi-autonomous myoelectric control algorithm
Standard-of-care myoelectric control algorithm
Sponsored by
Point Designs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Amputation; Traumatic, Arm, Upper

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado Boulder

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard-of-care myoelectric control algorithm

Semi-autonomous myoelectric control algorithm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 8, 2021
Last Updated
September 26, 2022
Sponsor
Point Designs
Collaborators
University of Colorado, Boulder
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1. Study Identification

Unique Protocol Identification Number
NCT05048394
Brief Title
Teleoperation Experimental Comparison With Able-bodied Subjects
Official Title
Teleoperation Experimental Comparison With Able-bodied Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Point Designs
Collaborators
University of Colorado, Boulder

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation; Traumatic, Arm, Upper

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard-of-care myoelectric control algorithm
Arm Type
Experimental
Arm Description
The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand
Arm Title
Semi-autonomous myoelectric control algorithm
Arm Type
Experimental
Arm Description
The semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.
Intervention Type
Device
Intervention Name(s)
Semi-autonomous myoelectric control algorithm
Intervention Description
The semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.
Intervention Type
Device
Intervention Name(s)
Standard-of-care myoelectric control algorithm
Intervention Description
The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.
Primary Outcome Measure Information:
Title
Assessment of Capacity for Myoelectric Control (ACMC)
Description
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
Time Frame
Day 1 (1 hour)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Segil, Phd
Phone
3037357313
Email
jacob.segil@colorado.edu
Facility Information:
Facility Name
University of Colorado Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Segil, PhD
Phone
303-735-7313
Email
jacob.segil@colorado.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Teleoperation Experimental Comparison With Able-bodied Subjects

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