Autonomous Navigating Robot for Detecting Falls and Risk of Falls in Nursing Home Residents With Alzheimer Disease/ADRD - Feasibility Study

February 27, 2026 updated by: Yuval Malinsky, Vigorous Mind, Inc.

Autonomous Navigating Robot for Detecting Falls and Risk of Falls in Nursing Home Residents With Alzheimer Disease/ADRD

This study is a feasibility study to prove that an autonomously navigating robot can patrol nursing home rooms day and night and detect if a resident has fallen, turn on ambient light at night and a video camera and allow nursing staff to view and assess the situation through the robot video camera and communicate with the resident through the robot screen.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Intervention Protocol Prior to sending the robot on patrol to detect whether a resident is attempting to get up from the chair or bed or if a resident fell, we will get residents used to the robot. We will do this through the morning musical wake up tour playing "Oh What a Beautiful Morning" for a month. We will explain to the residents that the robot will come to "visit" them on a regular basis to see how they are doing and demonstrate how the robot comes and observes them. Using an infra-red camera and artificial intelligence, the robot can find where a human is located in the room and in what position. If it visits a private room and the robot "sees" that a resident is not on the floor or is on her/his wheel chair or couch or in bed and is not attempting to get up or out of bed or stand up, it will just turn around and leave the room without interrupting the resident. If it detects that a human is on the floor, it will say "This is temi the robot, I am getting help". It will turn on ambient light, alert staff and turn on the robot video camera to facilitate communication between the staff and the resident so staff can assess the situation and take proper action. If it detects that there is more than one human in the room and no human is on the floor, it will leave the room. If there is another human in the room and one human is on the floor, it will alert staff. If the second person in the room is a staff member, s/he will be able to click a button on the robot screen to send it to continue the patrol and it will leave the room and continue the patrol. If the room is a semiprivate room and there are two residents living there, the robot will check on one resident and if s/he is not at risk it will turn around and check the status of the second resident. If both are resting, the robot will leave the room without interrupting the residents. If the robot detects that a resident is attempting to get up or out of bed it will say: "this is temi the robot, please sit, I am getting help". It will turn on ambient light and its video camera and alert staff. If it detects that a resident is on the floor, it will perform the procedure described above. If a staff member is already in a semi-private room where there was a fall, s/he will be able to send the robot to continue the patrol or task as described in the private room. All falls reported by the robot will have an image captured so that the fall can be verified by research staff. Falls reported by the staff and robot will be tabulated according to their concordance: 1) Robot correctly detected and reported but staff did not record a fall; 2) staff reported fall but robot did not; 3) robot correctly and staff reported a fall; and, 4) robot reports fall: no image in robot recording to validate that a fall occurred and staff does not report a fall.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

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

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Steere House Nursing & Rehabilitation Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Nursing home residents living with dementia

Description

Inclusion Criteria:

  • Nursing home resident living with dementia

Exclusion Criteria:

  • Residents on isolation precautions (e.g. Clostridoides difficile, COVID 19, MRSA)
  • Actively dying resident
  • Resident and/or family decline
  • Functional or structural quadriplegia with inability to mobilize with little to no risk of falling
  • Residents become agitated when the robot engages with them

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
A robot will patrol the rooms of nursing home residents to detect falls
Nursing home residents in a long-term-care memory unit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of a robot to detect falls in a nursing home
Time Frame: during three months
The Primary Outcome Measure is that 95% of the time the robot correctly detected that a resident fell, was able to turn on ambient light, alert nursing staff, turn on the video camera and facilitate communication between the resident and nursing staff.
during three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nursing staff satisfaction with the robot detection of falls
Time Frame: during three months
75% of nursing staff said that the fall detection system improved their ability to provide safe care
during three months
The robot was able to detect falls in the nursing home before the nursing staff
Time Frame: During three months
That in more than 30% of falls the robot detected the falls before the nursing staff.
During three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vigorous Mind, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lynn McNicoll, BS, MDCM, Brown University Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Malinsky Y,McNicoll L,Gravenstein S

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VMRFalls1
  • 1R43AG082599-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD is collected

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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