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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vision-guided control vs Default control | Experimental | New custom control method vs default method |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compare two control methods for a wheelchair-mounted robotic manipulator | 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 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Ding, PhD | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15240 | United States |
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The investigators recruited participants through three Institutional Review Board (IRB) approved registries. The investigators have also recruited through distributing the recruitment flyer to rehab facilities throughout the VA Pittsburgh Healthcare System and the Center for Assistive Technology at the University of Pittsburgh Medical Center. Four participants did not complete the baseline questionnaire and subsequent visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Group: Voice-Guided System (VGS) Followed by Default Teleoperation Control | All participants receive Intervention A (VGS) during Phase 1, followed by Intervention B (Teleoperation Control) during Phase 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment/Screening |
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| Interventions/Study Period |
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This single-arm study enrolled 21 participants; 4 did not pass screening, leaving 17 who started the study. Baseline analyses include 12 participants with complete and valid data. Five participants were excluded from analysis, as they were used to refine the study protocol and their data were not collected under consistent conditions and were therefore excluded from the final data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vision-guided Control vs Default Control | New custom control method vs default control method Compare two control methods for a wheelchair-mounted robotic manipulator: Participants pay two visits to the lab where they are asked to complete two multi-step manipulation tasks using a wheelchair-mounted robotic manipulator first using the new custom vision-guided control and then default teleoperation (joystick or switch) control. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participant age in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The first five participants were used to refine the study protocol. As procedural adjustments were made during this early phase, their data were not collected under consistent conditions and were therefore excluded from the final analysis | Posted | Mean | Standard Deviation | seconds | 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 participant completed two laboratory visits (~ 6 hours total). At each visit, one functional task (Drinking or Popcorn) was tested under both control conditions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vision-guided Control vs Default Teleoperation Control | New custom control method vs default method Compare two control methods for a wheelchair-mounted robotic manipulator (default manual joystick/switch control vs vision-guided shared [VGS] control). Participants completed two lab visits (<3 hours each): drinking and popcorn. At each visit, participants performed 2 trials per control method; task completion time and trial success were recorded after each trial (4 measurements per visit), and NASA-TLX and SUS were completed once per control method after both trials (2 ratings per visit). |
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Presenting the VGS condition first removed full counterbalancing and may have introduced order effects, such as improved manual performance from task familiarity. Participants were novice users with no prior experience using a robotic arm, which may have influenced performance and subjective feedback. Limited exposure time also restricted their ability to evaluate long-term usability or adaptation effects. The small, heterogeneous sample and controlled lab environment limit generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dan Ding | VA Pittsburgh Healthcare System | 412-624-1964 | dan.ding@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2023 | Jun 20, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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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.
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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) | 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). |
| Standard Deviation |
| years |
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| Sex: Female, Male | Participant Sex (Female or male) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Participant self-reported Ethnicity | Count of Participants | Participants |
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| Race (NIH/OMB) | Participant self-reported Race | Count of Participants | Participants |
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| Diagnosis | Medical Diagnosis Reported by Participants | Count of Participants | Participants |
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| Spinal Cord Injury (SCI) Functional Index (FI) | The Spinal Cord Injury-Functional Index (SCI-FI) Self-Care Short Form assesses the ability of individuals with spinal cord injury to perform daily self-care activities such as dressing, grooming, and eating. Scores are reported as T-scores (mean = 50, SD = 10) based on a reference population of adults with traumatic SCI. A T-score of 50 represents average self-care ability in this reference population, and higher scores indicate greater independence. | Mean | Standard Deviation | T-score (standardized score) |
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| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Vision-guided Control vs Default Control | New custom control method (VGS) vs default method |
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| Primary | 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. | Posted | Mean | Standard Deviation | Percentage of successful steps | 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). |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score (0-100) | 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). |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score (0-100) | 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). |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D014947 | Wounds and Injuries |
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| Popcorn Task Using Default Control |
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| Popcorn Task Using Default Control |
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| Popcorn Task using Default Control |
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