Trial Outcomes & Findings for Evaluation of Vision-Guided Shared Control for Assistive Robotics Manipulators (NCT NCT04323449)

NCT ID: NCT04323449

Last Updated: 2026-02-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

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).

Results posted on

2026-02-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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.
Enrollment/Screening
STARTED
21
Enrollment/Screening
COMPLETED
17
Enrollment/Screening
NOT COMPLETED
4
Interventions/Study Period
STARTED
17
Interventions/Study Period
COMPLETED
12
Interventions/Study Period
NOT COMPLETED
5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Vision-Guided Shared Control for Assistive Robotics Manipulators

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Vision-guided Control vs Default Control
n=12 Participants
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.
Age, Continuous
52.4 years
STANDARD_DEVIATION 18.9 • n=25 Participants
Sex: Female, Male
Female
3 Participants
n=25 Participants
Sex: Female, Male
Male
9 Participants
n=25 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=25 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=25 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=25 Participants
Race (NIH/OMB)
Asian
1 Participants
n=25 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=25 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=25 Participants
Race (NIH/OMB)
White
11 Participants
n=25 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=25 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=25 Participants
Diagnosis
Spinal Cord Injury
4 Participants
n=25 Participants
Diagnosis
Cerebral Palsy
3 Participants
n=25 Participants
Diagnosis
Muscular Dystrophy
2 Participants
n=25 Participants
Diagnosis
Other
3 Participants
n=25 Participants
Spinal Cord Injury (SCI) Functional Index (FI)
50 T-score (standardized score)
STANDARD_DEVIATION 10 • n=25 Participants

PRIMARY outcome

Timeframe: 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).

Population: 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

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.

Outcome measures

Outcome measures
Measure
Vision-guided Control vs Default Control
n=12 Participants
New custom control method (VGS) vs default method
Task Completion Time
Drinking Task using VGS Control
333.7 seconds
Standard Deviation 211.3
Task Completion Time
Drinking Task with Default Control
604.7 seconds
Standard Deviation 368.9
Task Completion Time
Popcorn Task Using VGS Control
748.5 seconds
Standard Deviation 204.3
Task Completion Time
Popcorn Task Using Default Control
1128.9 seconds
Standard Deviation 389.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Vision-guided Control vs Default Control
n=12 Participants
New custom control method (VGS) vs default method
Success Rate
Drinking Task using VGS Control
95.8 Percentage of successful steps
Standard Deviation 6.6
Success Rate
Drinking Task with Default Control
86.1 Percentage of successful steps
Standard Deviation 8.9
Success Rate
Popcorn Task Using VGS Control
93.8 Percentage of successful steps
Standard Deviation 5.7
Success Rate
Popcorn Task Using Default Control
89.2 Percentage of successful steps
Standard Deviation 10.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Vision-guided Control vs Default Control
n=12 Participants
New custom control method (VGS) vs default method
NASA Task Load Index (TLX)
Drinking Task using VGS Control
25.8 Score (0-100)
Standard Deviation 17.7
NASA Task Load Index (TLX)
Drinking Task with Default Control
41.3 Score (0-100)
Standard Deviation 22.3
NASA Task Load Index (TLX)
Popcorn Task Using VGS Control
30 Score (0-100)
Standard Deviation 14.7
NASA Task Load Index (TLX)
Popcorn Task Using Default Control
42.4 Score (0-100)
Standard Deviation 19.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Vision-guided Control vs Default Control
n=12 Participants
New custom control method (VGS) vs default method
System Usability Scale (SUS)
Drinking Task using VGS Control
72.1 Score (0-100)
Standard Deviation 19.7
System Usability Scale (SUS)
Drinking Task with Default Control
65.6 Score (0-100)
Standard Deviation 19.2
System Usability Scale (SUS)
Popcorn Task Using VGS Control
69.2 Score (0-100)
Standard Deviation 22.9
System Usability Scale (SUS)
Popcorn Task using Default Control
64.6 Score (0-100)
Standard Deviation 27.9

Adverse Events

Vision-guided Control vs Default Teleoperation Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dan Ding

VA Pittsburgh Healthcare System

Phone: 412-624-1964

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place