Spinal Cord Injury/DisorderARM ControlNCT04323449
Evaluation of Vision-Guided Shared Control for Assistive Robotics Manipulators
A study of Spinal Cord Injury/Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury/Disorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- people with impaired vision
- people with pressure ulcers that prevent them from sitting continuously for an extended period of time
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injury/Disorder
- Being tested
- Compare two control methods for a wheelchair-mounted robotic manipulator
- Keywords
- Assistive devices, Wheelchairs, Activities of daily living, Assistive robotic manipulators
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compare two control methods for a wheelchair-mounted robotic manipulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Vision-guided control vs Default control | Experimental | New custom control method vs default method Receives: Device: Compare two control methods for a wheelchair-mounted robotic manipulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task Completion Time
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.
Measured: 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
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.
Measured: 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 outcomes (2)
NASA Task Load Index (TLX)
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.
Measured: 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)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start13 Apr 2022
- Primary completion21 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord Injury/DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive both interventions sequentially: VGS control followed by default teleoperation control. The study uses a non-randomized, within-subject design, allowing each participant to serve as their own control when comparing outcomes across interventions. We chose not to randomize the order of interventions because findings from pilot testing indicated that completing the study in a randomized order imposed excessive cognitive and physical demands on participants. Pilot participants reported that beginning with the VGS control facilitated learning and adjustment to the subsequent teleoperation control, reducing frustration and fatigue. Additionally, the primary purpose of this study is not to directly compare the two control methods, but rather to explore how VGS may offer advantages in usability, efficiency, and user confidence. Although this fixed sequence may introduce potential order effects, prioritizing participant comfort and ensuring meaningful insights.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dan Ding, PhD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323449
- Sponsor's protocol ID
- B3242-R
- Acronym
- ARM Control
- Status last verified
- Jan 2026
- First submitted
- 18 Mar 2020
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Vision-Guided Shared Control for Assistive Robotic Manipulators
- ClinicalTrials.gov ID
- NCT04323449
- Acronym / sponsor ID
- ARM Control / B3242-R
- Conditions
- Spinal Cord Injury/Disorder
- Keywords
- Assistive devices, Wheelchairs, Activities of daily living, Assistive robotic manipulators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive both interventions sequentially: VGS control followed by default teleoperation control. The study uses a non-randomized, within-subject design, allowing each participant to serve as their own control when comparing outcomes across interventions. We chose not to randomize the order of interventions because findings from pilot testing indicated that completing the study in a randomized order imposed excessive cognitive and physical demands on participants. Pilot participants reported that beginning with the VGS control facilitated learning and adjustment to the subsequent teleoperation control, reducing frustration and fatigue. Additionally, the primary purpose of this study is not to directly compare the two control methods, but rather to explore how VGS may offer advantages in usability, efficiency, and user confidence. Although this fixed sequence may introduce potential order effects, prioritizing participant comfort and ensuring meaningful insights.
| Arm | Type | Receives |
|---|---|---|
| Vision-guided control vs Default control | Experimental | Device: Compare two control methods for a wheelchair-mounted robotic manipulatorNew custom control method vs default method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- people with impaired vision
- people with pressure ulcers that prevent them from sitting continuously for an extended period of time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compare two control methods for a wheelchair-mounted robotic manipulatorParticipants 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. | Device | Vision-guided control vs Default control |
Primary outcome
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.
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.
2 secondary outcomes
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).
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Ding, PhD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Spinal Cord Injury/Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.