NCT03619200

Brief Summary

FallSensing screening tool is a technological solution for fall risk screening, including a software, a pressure platform and two inertial sensors. The screening includes questions about demographic and anthropometric data, health and lifestyle behaviors, a detailed explanation about procedures to accomplish six functional tests (Grip Strength, Timed Up and Go, 30 seconds Sit-to-Stand, Step test, 4 Stage Balance test "modified" and 10 meters Walking Speed) and three questionnaires concerning environmental home hazards, activities and participation profile related to mobility and self-efficacy for exercise.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
506

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

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

Study Start

First participant enrolled

June 22, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

May 19, 2018

Last Update Submit

August 6, 2018

Conditions

Accidental Falls

Keywords

Primary preventionAdultsPressure platformInertial SensorsClinical Protocol

Outcome Measures

Primary Outcomes (1)

  • History of Fall

    Falls occurrence in the 12 months follow up period. "Did you fall in the past month?"

    Monthly for a 12 months period

Secondary Outcomes (29)

  • History of fall (Previous 12 months)

    Day 0

  • Fear of Falling

    Day 0

  • Grip Strength

    Day 0

  • Timed Up and Go

    Day 0

  • 30 seconds Sit-to-Stand

    Day 0

  • +24 more secondary outcomes

Study Arms (2)

Fallers

Participants who reported at least one fall in the 12-months follow-up period were categorized as "fallers".

Non-Fallers

Participants who did not report any fall in the 12-months follow-up period were categorized as "non-fallers".

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals are voluntarily recruited from several settings from the community, in different regions of continental Portugal, such as parish councils, physical therapy clinics, senior's universities and other facilities.

You may qualify if:

  • adults aged 50 years or over,
  • Community-dweller
  • independent to be standing and walking, with or without walking aids
  • interest to participate in the study.

You may not qualify if:

  • severe sensorial impairments (deafness or blindness)
  • cognitive impairments which precludes the ability to comprehend the questionnaires and functional tests included in the screening protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 19, 2018

First Posted

August 7, 2018

Study Start

June 22, 2016

Primary Completion

January 16, 2018

Study Completion

January 16, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08