NCT02272933

Brief 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). 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

3.2 years

First QC Date

October 21, 2014

Last Update Submit

December 11, 2019

Conditions

Accidental FallsGait, Unsteady

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (1)

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.

Device: Smart SlipperDevice: Belt-Clip Sensor

Interventions

Smart SlipperDEVICE

The shoe measures foot pressure and motion allowing gait to be quantified.

Wireless Body-Worn Sensors
Belt-Clip SensorDEVICE

The sensor measures acceleration of the body allowing falls to be detected.

Wireless Body-Worn Sensors

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. Unwilling to participate 2. Not mentally competent to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Garrison Geriatric Education and Care Center

Lubbock, Texas, 79415, United States

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ron Banister, MD

    Texas Tech University Health Sciences Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 23, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

December 13, 2019

Record last verified: 2019-12

Locations

US(1)