NCT03114800

Brief 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. Ten healthy participants will perform video-recorded bed movements while weight distribution and interface pressures at bony prominences on the pelvis are recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 9, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

21 days

First QC Date

April 10, 2017

Last Update Submit

October 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight change

    Weight change at each load cell

    1 hour

Study Arms (1)

E-Scale

EXPERIMENTAL

Weight monitoring

Device: E-Scale

Interventions

E-ScaleDEVICE

The E-Scale is comprised of a series of weight monitoring 'pods' and a set of software modules that facilitate data transfer and analysis.

Also known as: Embedded Scale
E-Scale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older

You may not qualify if:

  • Not able to independently get onto a bed and reposition themselves
  • Skin lesions in the area where sensors will be placed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakery Square

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jonathan Pearlman, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 14, 2017

Study Start

August 9, 2017

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

October 9, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

IPD data will be used to develop a proprietary algorithm

Locations