Accidental FallsGFD1NCT02272933
Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors
A study testing Smart Slipper and Belt-Clip Sensor in people with Accidental Falls and Gait, Unsteady, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
In this observational study, a motion monitoring system including body-worn sensors, communication portals, data capture system, and algorithms will be tested with geriatric patients in Garrison Geriatric Education and Care Center (Lubbock, TX). Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Gait, Unsteady
- What is being tested?
- Smart Slipper and Belt-Clip Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 30 day resident of Garrison.
- Deemed mentally competent by primary care provider to make decisions regarding their daily shoe wear.
- A resident prone to falls is eligible.
- Willing to wear shoes and offer high level of compliance to study
- Able to provide informed consent
- Able to complete survey
- Age range: 45-85 yrs
Who cannot join
- 1. Unwilling to participate 2. Not mentally competent to provide informed consent
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Garrison Geriatric Education and Care Center
Lubbock, Texas, 79415
About this study
In this observational study, a motion monitoring system including body-worn sensors, communication portals, data capture system, and algorithms will be tested with geriatric patients in Garrison Geriatric Education and Care Center (Lubbock, TX). The study is part of a long-term effort to improve the quality of life and safety of geriatric patients by using autonomous systems that can alert care givers of mobility issues and falls.
Read the detailed description
Medical monitoring systems have become an important area of research and development due to the possibility of allowing improved quality of life and care while reducing overall medical costs.
Significance of the study:
The study is significant because it will allow researchers to understand the efficacy of the autonomous sensor system used with actual residents of a geriatric care center. This study is one of the first attempts to monitor movements of geriatric residents as they go about their activities of daily living. This type of system has the potential to improve the quality of life and safety of geriatric patients.
Goals:
The development of autonomous patient monitoring technologies that will eventually improve the quality of life and safety of patients in geriatric care facilities and other environments.
Determine the performance and usability of the wearable sensor system in a geriatric care facility with actual residents going about their daily lives.
Specific Aims:
- Determine performance of motion data collect ion system for monitoring geriatric residents as they go about their daily life in a geriatric center
- Determine tolerability of wearing sensors by geriatric residents
- Understand how medical staff interacts with monitored residents and the sensor devices
- Determine if the sensor system's algorithms can identify falls
Objectives:
- Analyze the motion data generated by the system to determine system performance. The list of performance metrics will include: (a) system up-time, (b) continuity of data collection (c) sensor device failure rate, (d) sensor device battery life (e) simultaneous collection of data when multiple monitored residents are in the same localized area.
- Assess the tolerability of wearing the devices over the course of a day using a survey administered to residents.
- Assess the usability of the sensor system using a survey administered to care givers.
- Compare events flagged as falls by system algorithms with the fall log produced by Garrison staff, cross-verified against personal fall logs, to determine the ability of the system to detect falls.
- Conditions
- Accidental Falls, Gait, Unsteady
- Being tested
- Smart Slipper, Belt-Clip Sensor
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart SlipperDevice
The shoe measures foot pressure and motion allowing gait to be quantified.
Belt-Clip SensorDevice
The sensor measures acceleration of the body allowing falls to be detected.
| Study group | Role | What they receive |
|---|---|---|
| Wireless Body-Worn Sensors | Experimental | Elderly patients will wear sensors (Smart Slippers and a belt-clip sensor) as they go about their daily life in a geriatric care center. Receives: Device: Smart Slipper; Device: Belt-Clip Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Fall Incidences
Participants will be monitored for falls. The detection of fall events as determined by the sensors will be compared to the fall log kept by Garrison Geriatric Center.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: No Study Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Tech University
- Responsible party
- Sponsor
- Investigators
- Ron Banister, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272933
- Sponsor's protocol ID
- L14-125
- Acronym
- GFD1
- Status last verified
- Dec 2019
- First submitted
- 21 Oct 2014
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors
- ClinicalTrials.gov ID
- NCT02272933
- Acronym / sponsor ID
- GFD1 / L14-125
- Conditions
- Accidental Falls, Gait, Unsteady
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Study Enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Collaborators
- Texas Tech University
- Study start
- Aug 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 23 Oct 2014 (estimated)
- 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 observational study, a motion monitoring system including body-worn sensors, communication portals, data capture system, and algorithms will be tested with geriatric patients in Garrison Geriatric Education and Care Center (Lubbock, TX). The study is part of a long-term effort to improve the quality of life and safety of geriatric patients by using autonomous systems that can alert care givers of mobility issues and falls.
Detailed description
Medical monitoring systems have become an important area of research and development due to the possibility of allowing improved quality of life and care while reducing overall medical costs.
Significance of the study:
The study is significant because it will allow researchers to understand the efficacy of the autonomous sensor system used with actual residents of a geriatric care center. This study is one of the first attempts to monitor movements of geriatric residents as they go about their activities of daily living. This type of system has the potential to improve the quality of life and safety of geriatric patients.
Goals:
The development of autonomous patient monitoring technologies that will eventually improve the quality of life and safety of patients in geriatric care facilities and other environments.
Determine the performance and usability of the wearable sensor system in a geriatric care facility with actual residents going about their daily lives.
Specific Aims:
- Determine performance of motion data collect ion system for monitoring geriatric residents as they go about their daily life in a geriatric center
- Determine tolerability of wearing sensors by geriatric residents
- Understand how medical staff interacts with monitored residents and the sensor devices
- Determine if the sensor system's algorithms can identify falls
Objectives:
- Analyze the motion data generated by the system to determine system performance. The list of performance metrics will include: (a) system up-time, (b) continuity of data collection (c) sensor device failure rate, (d) sensor device battery life (e) simultaneous collection of data when multiple monitored residents are in the same localized area.
- Assess the tolerability of wearing the devices over the course of a day using a survey administered to residents.
- Assess the usability of the sensor system using a survey administered to care givers.
- Compare events flagged as falls by system algorithms with the fall log produced by Garrison staff, cross-verified against personal fall logs, to determine the ability of the system to detect falls.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wireless Body-Worn Sensors | Experimental | Device: Smart Slipper, Device: Belt-Clip SensorElderly patients will wear sensors (Smart Slippers and a belt-clip sensor) as they go about their daily life in a geriatric care center. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 30 day resident of Garrison.
- Deemed mentally competent by primary care provider to make decisions regarding their daily shoe wear.
- A resident prone to falls is eligible.
- Willing to wear shoes and offer high level of compliance to study
- Able to provide informed consent
Key exclusion criteria (2 listed)
- 1. Unwilling to participate 2. Not mentally competent to provide informed consent
- -
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 |
|---|---|---|
| Smart SlipperThe shoe measures foot pressure and motion allowing gait to be quantified. | Device | Wireless Body-Worn Sensors |
| Belt-Clip SensorThe sensor measures acceleration of the body allowing falls to be detected. | Device | Wireless Body-Worn Sensors |
Primary outcome
Detection of Fall Incidences
Time frame: 6 months
Participants will be monitored for falls. The detection of fall events as determined by the sensors will be compared to the fall log kept by Garrison Geriatric Center.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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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.
Ron Banister, MD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Slipper and Belt-Clip Sensor in people with Accidental Falls and Gait, Unsteady, run by Texas Tech University Health Sciences Center 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 7 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: withdrawn, as of the sponsor's last update on 13 Dec 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Detection of Fall Incidences (time frame: 6 months). 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 13 Dec 2019.