Pressure UlcerNCT03114800
Monitoring Movement for Pressure Ulcer Prevention
A study testing E-Scale in people with Pressure Ulcer, run by Jonathan Pearlman at 1 site in United States.
Trial summary
The goal of this work is to develop and test an automated movement detection monitoring tool that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence rates. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- E-Scale
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2017to 30 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and older
Who cannot join
- Not able to independently get onto a bed and reposition themselves
- Skin lesions in the area where sensors will be placed
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this work is to develop and test an automated movement detection monitoring tool that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence rates. Ten healthy participants will perform video-recorded bed movements while weight distribution and interface pressures at bony prominences on the pelvis are recorded.
Read the detailed description
The incidence rate and subsequent costs of preventable pressure ulcers is astounding. Although pressure ulcer risk assessment tools and prevention approaches have been a topic of research and for many years, the incidence rate has remained relatively consistent. One reason that progress has not been made to lower the incidence rate is that there is no objective monitoring tool to determine how much a person is moving or is being moved in their bed. Current practices are time-intensive and have not yet leveraged intelligent monitoring technology that could reduce clinical burden and increase accuracy of the risk assessment and efficacy of prevention protocols. The goal of this work is to develop and test an automated movement detection monitoring tool that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence rates. This monitoring tool will be an extension of our intelligent bed sensor we developed named the Embedded Scale, or E-Scale. The E-Scale currently has software modules that detect bed exit, individual weight, and multi-person weight. The project described here would develop a movement module for the E- Scale to monitor people's movements in bed in an attempt to eventually reduce incidence of pressure ulcers in clinical care.
- Conditions
- Pressure Ulcer
- Being tested
- E-Scale
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-ScaleDevice
Also called Embedded Scale
The E-Scale is comprised of a series of weight monitoring 'pods' and a set of software modules that facilitate data transfer and analysis.
| Study group | Role | What they receive |
|---|---|---|
| E-Scale | Experimental | Weight monitoring Receives: Device: E-Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Weight change at each load cell
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start9 Aug 2017
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Pearlman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonathan Pearlman, University of Pittsburgh
- Investigators
- Jonathan Pearlman, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114800
- Sponsor's protocol ID
- PRO16120412
- Status last verified
- Oct 2017
- First submitted
- 10 Apr 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will be used to develop a proprietary algorithm
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Movement for Pressure Ulcer Prevention
- ClinicalTrials.gov ID
- NCT03114800
- Acronym / sponsor ID
- PRO16120412
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jonathan PearlmanUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 14 Apr 2017 (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.
The goal of this work is to develop and test an automated movement detection monitoring tool that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence rates. Ten healthy participants will perform video-recorded bed movements while weight distribution and interface pressures at bony prominences on the pelvis are recorded.
Detailed description
The incidence rate and subsequent costs of preventable pressure ulcers is astounding. Although pressure ulcer risk assessment tools and prevention approaches have been a topic of research and for many years, the incidence rate has remained relatively consistent. One reason that progress has not been made to lower the incidence rate is that there is no objective monitoring tool to determine how much a person is moving or is being moved in their bed. Current practices are time-intensive and have not yet leveraged intelligent monitoring technology that could reduce clinical burden and increase accuracy of the risk assessment and efficacy of prevention protocols. The goal of this work is to develop and test an automated movement detection monitoring tool that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence rates. This monitoring tool will be an extension of our intelligent bed sensor we developed named the Embedded Scale, or E-Scale. The E-Scale currently has software modules that detect bed exit, individual weight, and multi-person weight. The project described here would develop a movement module for the E- Scale to monitor people's movements in bed in an attempt to eventually reduce incidence of pressure ulcers in clinical care.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-Scale | Experimental | Device: E-ScaleWeight monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 and older
Key exclusion criteria (2 listed)
- Not able to independently get onto a bed and reposition themselves
- Skin lesions in the area where sensors will be placed
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 |
|---|---|---|
| E-ScaleAlso: Embedded ScaleThe E-Scale is comprised of a series of weight monitoring 'pods' and a set of software modules that facilitate data transfer and analysis. | Device | E-Scale |
Primary outcome
Weight change
Time frame: 1 hour
Weight change at each load cell
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Individual participant dataSharing planned: No. IPD data will be used to develop a proprietary algorithm
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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.
Jonathan Pearlman, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Scale in people with Pressure Ulcer, run by Jonathan Pearlman 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 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: finished, as of the sponsor's last update on 9 Oct 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight change (time frame: 1 hour). 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 9 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.