- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04323449
Evaluation of Vision-Guided Shared Control for Assistive Robotics Manipulators (ARM Control)
January 28, 2026 updated by: VA Office of Research and Development
Development of Vision-Guided Shared Control for Assistive Robotic Manipulators
The purpose of this study is to evaluate a new control (i.e., the vision-guided shared (VGS) control) for a wheelchair-mounted assistive robotic manipulator among powered wheelchair users.
This study consists of a questionnaire about general demographics, health information, and previous experience with assistive technology.
Several tests are also 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 are eligible for participation in the study.
Eligible participants will move on to a second training phase where they are asked to learn and practice slightly more complex tasks while using the vision-guided shared controller.
After this training, participants are asked to complete two everyday tasks each comprising multiple steps using the VGS control and default teleoperation using a joystick.
At the conclusion of the study, researchers 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 develop and evaluate a vision-guided shared (VGS) control to address the effectiveness and efficiency of ARMs for real-world use.
The VGS control uses fiducial markers on objects or adaptive tools to make vision-based tracking robust and reliable for real-world applications.
It allows 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 powered wheelchair users to complete a set of everyday manipulation tasks.
Participants complete two multi-step manipulation tasks using the new VGS control method and the default teleoperation method.
Researchers collect outcome measures in terms of efficiency (i.e., task completion time), effectiveness (i.e., task completion success rate), and usability, i.e., NASA Task Load Index (NASA TLX), and System Usability Scale (SUS).
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15240
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vision-guided control vs Default control
New custom control method vs default method
|
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 first using the new custom vision-guided shared (VGS) control, and after a break, using default joystick or switch control.
The sequence of the two control methods are fixed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Task Completion Time
Time Frame: Two lab visits (<3 hours each). At each visit (drinking; popcorn), task completion time was recorded after each trial for default manual control and for VGS control (2 trials per control; 4 measurements per visit).
|
Each task consisted of multiple predefined steps (six for the Drinking Task and ten for the Popcorn Task).
Participants performed two trials per task.
The time of completion was defined as the total time (in seconds) required to complete all steps, measured from the start cue to task completion.
Each step had a 5-minute limit; if not completed within that time, the step was considered failed and assigned the maximum 5-minute duration before proceeding to the next step.
Task completion times were summarized using descriptive statistics, with average times calculated across all trials, including failed steps assigned the maximum 5-minute duration.
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Two lab visits (<3 hours each). At each visit (drinking; popcorn), task completion time was recorded after each trial for default manual control and for VGS control (2 trials per control; 4 measurements per visit).
|
|
Success Rate
Time Frame: Two lab visits (<3 hours each). At each visit (drinking; popcorn), success rate was recorded after each trial for default manual control and for VGS control (2 trials per control; 4 measurements per visit).
|
Success rate was defined as the number of task steps successfully completed within the 5-minute limit, out of a total of 12 trials (6 steps performed twice) for drinking task and 20 trials (10 steps performed twice) for popcorn task.
Each trial not completed within 5 minutes was counted as a failure.
|
Two lab visits (<3 hours each). At each visit (drinking; popcorn), success rate was recorded after each trial for default manual control and for VGS control (2 trials per control; 4 measurements per visit).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NASA Task Load Index (TLX)
Time Frame: Two lab visits (<3 hours each). At each visit (drinking; popcorn), participants completed 2 default manual control and 2 VGS control trials; NASA-TLX was completed once per control method after both trials (2 per visit).
|
The NASA Task Load Index (NASA-TLX) assesses participants' subjective workload after completing all tasks under each control method.
It includes six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration.
Each dimension is rated from 0 to 100, with higher scores indicating greater perceived workload.
The overall task load index is calculated as the average of the six dimension scores, resulting in a total score ranging from 0 to 100, where higher scores represent greater overall task load.
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Two lab visits (<3 hours each). At each visit (drinking; popcorn), participants completed 2 default manual control and 2 VGS control trials; NASA-TLX was completed once per control method after both trials (2 per visit).
|
|
System Usability Scale (SUS)
Time Frame: Two lab visits (<3 hours each). At each visit (drinking; popcorn), participants completed 2 default manual control and 2 VGS control trials; SUS was completed once per control method after both trials (2 per visit).
|
The System Usability Scale (SUS) is a 10-item questionnaire assessing perceived usability.
Each item is rated on a 5-point scale, and the total SUS score is converted to a 0-100 scale, with higher scores indicating better usability.
|
Two lab visits (<3 hours each). At each visit (drinking; popcorn), participants completed 2 default manual control and 2 VGS control trials; SUS was completed once per control method after both trials (2 per visit).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dan Ding, PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 13, 2022
Primary Completion (Actual)
June 21, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
March 18, 2020
First Submitted That Met QC Criteria
March 24, 2020
First Posted (Actual)
March 26, 2020
Study Record Updates
Last Update Posted (Actual)
February 17, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B3242-R
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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