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Evaluation of Vision-Guided Shared Control for Assistive Robotics Manipulators (ARM Control)

Primary Purpose

Spinal Cord Injury/Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compare two control methods for a wheelchair-mounted robotic manipulator
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injury/Disorder focused on measuring Assistive devices, Wheelchairs, Activities of daily living, Assistive robotic manipulators

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age and older
  • using a power wheelchair as primary means of mobility
  • having self reported difficulties in performing everyday manipulation tasks such as reaching for a glass of water, opening a refrigerator, and picking up a toothbrush

Exclusion Criteria:

  • people with impaired vision
  • people with pressure ulcers that prevent them from sitting continuously for an extended period of time

Sites / Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vision-guided control

Default control

Arm Description

New custom control method

Default control method (joystick or switch)

Outcomes

Primary Outcome Measures

Task completion time
The time it takes to complete each task successfully. Average time will be calculated over the total number of tasks selected by the participants.
Mode Switching Frequency
The number of times a participant has to switch modes for task completion based on logged control commands. The average number of times will be calculated over the total number of tasks selected by the participants.
Success rate
The number of tasks that can be completed successfully within the maximum assigned time over the total number of tasks selected by the participants.

Secondary Outcome Measures

NASA Task Load Index (TLX)
NASA TLX is to assess the subjective workload of participant after participants complete all the task using each control method. It consists of six dimensions: mental demands, physical demands, temporal demands, performance, effort and frustration. The score for each dimension ranges from 0 to 100 with a higher score indicating a higher workload. The overall task load index will be a weighted average of all six dimensions, where the weight for each dimension is obtained through pairwise comparisons of these dimensions.
System Usability Scale (SUS)
SUS is to collect perceived ease-of-use after each intervention. The SUS score ranges from 0 to 100 with a higher score indicating better usability and overall satisfaction.

Full Information

First Posted
March 18, 2020
Last Updated
April 19, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04323449
Brief Title
Evaluation of Vision-Guided Shared Control for Assistive Robotics Manipulators
Acronym
ARM Control
Official Title
Development of Vision-Guided Shared Control for Assistive Robotic Manipulators
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate a new control (i.e., the vision-guided shared control) for a wheelchair-mounted assistive robotic manipulator among powered wheelchair users. This study will consist of a questionnaire about general demographics, health information, and previous experience with assistive technology. Several tests will also be administered to test upper extremity function and ability as well as to test spatial orientation and visualization ability. Participants till then undergo a training phase with the assistive robotic manipulator mounted on a table to assess if they will be eligible for participation in the study. Eligible participants will move on to a second training phase where they will be asked to learn and practice slightly more complex tasks while using the vision-guided shared controller. After this training the assistive robotic manipulator will be mounted to the participants wheelchair and they will be asked to complete a number of everyday tasks from a task list. At the conclusion of the study, researchers will conduct a brief semi-structured interview with each participant and obtain more insight on how participants perceive the ease-of-use and usefulness of the vision-guided shared control.
Detailed Description
Veterans who use powered mobility devices including those with high-level spinal cord injury (SCI), amyotrophic lateral sclerosis (ALS), and multiple sclerosis (MS) often experience serious upper extremity impairments. Management and care of upper extremity impairments often involve a range of assistive solutions. However, product availability and technological advancement for manipulation assistance fall far behind those for mobility. Many of these individuals, despite their independent mobility, cannot reach for a glass of water, make a simple meal, and pick up a tooth brush. They still require assistance from a personal caregiver for essential activities of daily living (ADLs) involving reaching and object handling/manipulation. With the rapid advancement of robotics technology, assistive robotic manipulators (ARMs) emerge as a viable solution for assisting Veterans with upper extremity impairments to complete daily tasks involving reaching, object handling, and manipulation. ARMs are often equipped with many degrees of freedom (DOF), but users cannot control all of the DOFs at the same time with a conventional joystick, and need to switch modes quite often to complete even simple manipulation tasks, especially when an ARM gets close to the target and need to be aligned appropriately for manipulation. Thus existing ARMs suffer from the lack of efficiency and effectiveness especially in an unstructured environment. The goal of this project is to combine vision-guided shared (VGS) control with two types of environment modifications to address the effectiveness and efficiency of ARMs for real-world use. The two types of environment modifications include using commercial or custom adaptive tools (e.g., a holder that can hold a bottle or jar so an ARM can open it), and adding fiducial markers (similar to QR codes) to objects or adaptive tools to make vision-based tracking robust and reliable for real-world applications. Built upon the environment modifications, the VGS control will allow a user to initiate any task by moving an ARM close to a tagged object, and the ARM to take over fine manipulation upon detecting the target. This project is to evaluate the new control among 16 powered wheelchair users who will use a wheelchair-mounted ARM to complete a set of everyday manipulation tasks. Participants will complete a set of 10 manipulation tasks using the default control method and the new VGS control method. Researchers will collect outcome measures in terms of efficiency (i.e., task completion time and mode switching frequency), effectiveness (i.e., task completion success rate), and usability (i.e., NASA Task Load Index, and System Usability Scale). Investigators expect to improve manipulation functions of Veterans with upper limb impairments through a more practical and usable implementation of vision-based robotic control and human-robot interaction technologies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury/Disorder
Keywords
Assistive devices, Wheelchairs, Activities of daily living, Assistive robotic manipulators

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
After baseline, participants will be asked to complete the tasks with two control methods (the new vision-guided control vs the default control). The tasks will be randomly presented to each participant and the sequence of the two control methods will be counterbalanced.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vision-guided control
Arm Type
Experimental
Arm Description
New custom control method
Arm Title
Default control
Arm Type
Experimental
Arm Description
Default control method (joystick or switch)
Intervention Type
Device
Intervention Name(s)
Compare two control methods for a wheelchair-mounted robotic manipulator
Intervention Description
Participants will pay one visit to the lab where they will be asked to complete a set of manipulation tasks using a wheelchair-mounted robotic manipulator using the new custom vision-guided control and default joystick or switch control. The sequence of the two control methods will be counterbalanced.
Primary Outcome Measure Information:
Title
Task completion time
Description
The time it takes to complete each task successfully. Average time will be calculated over the total number of tasks selected by the participants.
Time Frame
After participants complete each task using each control method during the lab visit (which lasts about three hours for each control method)
Title
Mode Switching Frequency
Description
The number of times a participant has to switch modes for task completion based on logged control commands. The average number of times will be calculated over the total number of tasks selected by the participants.
Time Frame
After participants complete each task using each control method during the lab visit (which lasts about three hours for each control method)
Title
Success rate
Description
The number of tasks that can be completed successfully within the maximum assigned time over the total number of tasks selected by the participants.
Time Frame
After participants complete all tasks using each control method during the lab visit (which lasts about three hours for each control method)
Secondary Outcome Measure Information:
Title
NASA Task Load Index (TLX)
Description
NASA TLX is to assess the subjective workload of participant after participants complete all the task using each control method. It consists of six dimensions: mental demands, physical demands, temporal demands, performance, effort and frustration. The score for each dimension ranges from 0 to 100 with a higher score indicating a higher workload. The overall task load index will be a weighted average of all six dimensions, where the weight for each dimension is obtained through pairwise comparisons of these dimensions.
Time Frame
After participants complete all tasks with each control method during the lab visit (which lasts about three hours for each control method)
Title
System Usability Scale (SUS)
Description
SUS is to collect perceived ease-of-use after each intervention. The SUS score ranges from 0 to 100 with a higher score indicating better usability and overall satisfaction.
Time Frame
After participants complete all tasks with each control method during the lab visit (which lasts about three hours for each control method)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age and older using a power wheelchair as primary means of mobility having self reported difficulties in performing everyday manipulation tasks such as reaching for a glass of water, opening a refrigerator, and picking up a toothbrush Exclusion Criteria: people with impaired vision people with pressure ulcers that prevent them from sitting continuously for an extended period of time
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Ding, PhD
Phone
(412) 688-6000
Email
dad5@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rory A Cooper, PhD
Phone
(412) 365-4850
Email
rcooper@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Ding, PhD
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Ding, PhD
Phone
412-688-6000
Email
dad5@pitt.edu
First Name & Middle Initial & Last Name & Degree
Andrea M Bagay
Phone
(412) 822-3661
Email
Andrea.Bagay@va.gov
First Name & Middle Initial & Last Name & Degree
Dan Ding, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Vision-Guided Shared Control for Assistive Robotics Manipulators

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