Active Control (Robot on Screen)Early Phase 1NCT07885813
NRI: Robot-Assisted Longitudinal Physical and Cognitive Exercise Interventions for Older Veterans
A Early Phase 1 study testing Exercise with Assistive Robot in people with Active Control (Robot on Screen) and Adaptive Assistive Robot, run by Oregon State University at 1 site in United States.
Trial summary
In this protocol, the researchers will shift from the past short-term methods to a longer-term deployment and study of a robotic system in a skilled nursing facility setting. The research team will use a repeated baseline-intervention period to understand changes brought on by the robot, specifically. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Active Control (Robot on Screen), Adaptive Assistive Robot
- What is being tested?
- Exercise with Assistive Robot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2026to 7 Jan 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identifying as veterans and/or older adults
Who cannot join
- Below 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Final Long-Term Robot-Assisted Physical and Cognitive Exercise Interventions at the OVH
In this protocol, the researchers will shift from the past short-term methods to a longer-term deployment and study of a robotic system in a skilled nursing facility setting. The research team will use a repeated baseline-intervention period to understand changes brought on by the robot, specifically. The robot will be deployed in the partnering SNF ambiently (i.e., in a public setting where all residents can elect to use it on demand). Additionally, the researchers will make bi-weekly visits to check in and observe participants performing the intervention activity. The research team will share findings using academic conferences and journals.
Read the detailed description
The aim of this study is to empirically evaluate the impact of a robot (designed by the research team in previous efforts) on wellness-related exercise behaviors of older adults in a skilled nursing facility setting. The robot will be deployed in a common area and will be available for use by all residents as much or as little as they wish. During the intervention itself, the participants will perform physical exercises with the robotic system while also answering trivia questions to help maintain exercise engagement.
The research team will specifically test the hypothesis that for activity levels (measured by a wearable fitness tracker), bi-weekly self-reports (e.g., responses to questions about enjoyment, engagement, and exercise levels), and behavioral engagement in exercise will be higher during an intervention period with the assistive robot present vs. baseline and retention periods with a screen-based agent with a similar exercise-support function. Observation and measurement procedures remain the same across all conditions for ambient interactions with the robot.
- Being tested
- Exercise with Assistive Robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with Assistive RobotBehavioural
During the single arm of this study, participants will experience active control experiences with an onscreen version of an assistive robot (similar to the standard of care), as well as experimental experiences with an in-person version of the robot (a novel intervention). The robot is the system that has been designed by our research team based on previous design cycles with the Oregon Veterans' Home.
| Study group | Role | What they receive |
|---|---|---|
| ABAB Single-Case-Style Experience | Experimental | Our research team will complete participatory design steps and conduct a final long-term evaluation involving two intervention support phases: (1) a robotic intervention system that adapts over time and (2) an active control (an onscreen version of the same robot, similar to modern commercial technologies). We will be able to compare outcomes across phases, which follow an ABAB design with each phase being 1.5 months long. This design allows for each person to be compared to their own active control baseline, in addition to analyses of differences between the phases, allowing for meaningful insights even from a small study cohort. The proposed robotic intervention (i.e., a robot for physical and cognitive exercise) was identified by the skilled nursing facility stakeholders as their top desired robotic application in initial research team discussions. Receives: Behavioral: Exercise with Assistive Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
NNIH Toolbox Motor Battery Pegboard Test
Physical ability assessment involving a pegboard task.
Measured: Day 1 and every 14 of the study days after that, during the study period
NIH Toolbox Cognitive Measure Activities
Cognitive assessments from the NIH Toolboxes selected to test key aspects of cognition such as memory and sequencing.
Measured: Day 1 and every 14 days after that, during the study period
Secondary outcomes (7)
General Robot Opinions and Social Attributes of Robots Questions
Self-report questions to gauge participant view of robots and other technology.
Measured: Day 1 and final day of study
Box and Blocks Assessment
Objective measure of hand/arm function based on moving blocks from one box to another with in a minute time limit.
Measured: Day 1 and every 45 days after that, during the study period
Activities of Daily Living (ADL) Assessment
Assessment about participant abilities related to activities such as bathing, dressing, feeding, and toileting.
Measured: Day 1 and every 45 days after that, during the study period
Center for Epidemiological Studies-Depression (CES-D)
Assessments related to depression, which may influence other parts of performance in the study.
Measured: Day 1 and every 45 days after that, during the study period
Vigorousness of Motion (from Inertial Measurement Unit)
We will use an established data extraction pipeline to determine vigorousness of motion from the IMU data during sessions.
Measured: Day 1 and every 14 days after that, during the study period
Assessment and Life Satisfaction Index A (LSI-A)
Assessments related to life satisfaction, which may influence other parts of performance in the study.
Measured: Day 1 and every 45 days after that, during the study period
Exercise Pose Quality (from Video Recordings)
We will use camera data processing to extract skeleton pose during sessions and evaluate their fit with the desired exercise routines.
Measured: Day 1 and every 14 days after that, during the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start8 Jul 2026
- Primary completion6 Jan 2027 (estimated)
- Study completion7 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Control (Robot on Screen)Studies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Naomi Fitter, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885813
- Sponsor's protocol ID
- HE-2025-1899
- Other IDs
- R01AG078124
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Under the approved IRB protocol, we are unable to provide identifying data, but we may include anonymized datasets as part of our publishing as approved under the approved protocol.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Final Long-Term Robot-Assisted Physical and Cognitive Exercise Interventions at the OVH
- ClinicalTrials.gov ID
- NCT07885813
- Acronym / sponsor ID
- HE-2025-1899
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- 7 Jan 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this protocol, the researchers will shift from the past short-term methods to a longer-term deployment and study of a robotic system in a skilled nursing facility setting. The research team will use a repeated baseline-intervention period to understand changes brought on by the robot, specifically. The robot will be deployed in the partnering SNF ambiently (i.e., in a public setting where all residents can elect to use it on demand). Additionally, the researchers will make bi-weekly visits to check in and observe participants performing the intervention activity. The research team will share findings using academic conferences and journals.
Detailed description
The aim of this study is to empirically evaluate the impact of a robot (designed by the research team in previous efforts) on wellness-related exercise behaviors of older adults in a skilled nursing facility setting. The robot will be deployed in a common area and will be available for use by all residents as much or as little as they wish. During the intervention itself, the participants will perform physical exercises with the robotic system while also answering trivia questions to help maintain exercise engagement.
The research team will specifically test the hypothesis that for activity levels (measured by a wearable fitness tracker), bi-weekly self-reports (e.g., responses to questions about enjoyment, engagement, and exercise levels), and behavioral engagement in exercise will be higher during an intervention period with the assistive robot present vs. baseline and retention periods with a screen-based agent with a similar exercise-support function. Observation and measurement procedures remain the same across all conditions for ambient interactions with the robot.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABAB Single-Case-Style Experience | Experimental | Behavioral: Exercise with Assistive RobotOur research team will complete participatory design steps and conduct a final long-term evaluation involving two intervention support phases: (1) a robotic intervention system that adapts over time and (2) an active control (an onscreen version of the same robot, similar to modern commercial technologies). We will be able to compare outcomes across phases, which follow an ABAB design with each phase being 1.5 months long. This design allows for each person to be compared to their own active control baseline, in addition to analyses of differences between the phases, allowing for meaningful insights even from a small study cohort. The proposed robotic intervention (i.e., a robot for physical and cognitive exercise) was identified by the skilled nursing facility stakeholders as their top desired robotic application in initial research team discussions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Identifying as veterans and/or older adults
Key exclusion criteria (1 listed)
- Below 18 years
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 |
|---|---|---|
| Exercise with Assistive RobotDuring the single arm of this study, participants will experience active control experiences with an onscreen version of an assistive robot (similar to the standard of care), as well as experimental experiences with an in-person version of the robot (a novel intervention). The robot is the system that has been designed by our research team based on previous design cycles with the Oregon Veterans' Home. | Behavioural | ABAB Single-Case-Style Experience |
Primary outcome
NNIH Toolbox Motor Battery Pegboard Test
Time frame: Day 1 and every 14 of the study days after that, during the study period
Physical ability assessment involving a pegboard task.
NIH Toolbox Cognitive Measure Activities
Time frame: Day 1 and every 14 days after that, during the study period
Cognitive assessments from the NIH Toolboxes selected to test key aspects of cognition such as memory and sequencing.
7 secondary outcomes
General Robot Opinions and Social Attributes of Robots Questions
Time frame: Day 1 and final day of study
Box and Blocks Assessment
Time frame: Day 1 and every 45 days after that, during the study period
Activities of Daily Living (ADL) Assessment
Time frame: Day 1 and every 45 days after that, during the study period
Center for Epidemiological Studies-Depression (CES-D)
Time frame: Day 1 and every 45 days after that, during the study period
Vigorousness of Motion (from Inertial Measurement Unit)
Time frame: Day 1 and every 14 days after that, during the study period
Assessment and Life Satisfaction Index A (LSI-A)
Time frame: Day 1 and every 45 days after that, during the study period
Exercise Pose Quality (from Video Recordings)
Time frame: Day 1 and every 14 days after that, during the study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided. Under the approved IRB protocol, we are unable to provide identifying data, but we may include anonymized datasets as part of our publishing as approved under the approved protocol.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exercise with Assistive Robot in people with Active Control (Robot on Screen) and Adaptive Assistive Robot, run by Oregon State University 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
NNIH Toolbox Motor Battery Pegboard Test (time frame: Day 1 and every 14 of the study days after that, during the study period). 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 21 Oct 2026.