Evaluation of Vision-Guided Shared Control for Assistive Robotics Manipulators

NCT ID: NCT04323449

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-13

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury/Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vision-guided control

New custom control method

Group Type EXPERIMENTAL

Compare two control methods for a wheelchair-mounted robotic manipulator

Intervention Type DEVICE

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.

Default control

Default control method (joystick or switch)

Group Type EXPERIMENTAL

Compare two control methods for a wheelchair-mounted robotic manipulator

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Compare two control methods for a wheelchair-mounted robotic manipulator

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dan Ding, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B3242-R

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Spinal Neurorehabilitation for Veterans With SCI
NCT07222046 NOT_YET_RECRUITING NA