CClinicalTrials.gg
Status unknownNCT03591185Updated Jul 19, 2018

FallSensing Clinical Tool for Fall Risk Prevention in Community-dwelling Adults Aged 50 Years or Over

An interventional study of FallSensing Clinical Tool in Accidental Falls, sponsored by Anabela Correia Martins. Status unknown at 1 site in Portugal. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by Anabela Correia Martins · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jul 2017, registered Jun 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

Fall prevention programs should include strength and balance training, home hazard assessment and intervention, vision assessment and referral and also medication review with modification/withdrawal. Evidence exists that a tailored exercise program can reduce falls by as much as 54%.

Several studies recognize the benefits of the Otago Exercise Program (OEP) on physical functioning and falls reduction in older people. The program includes strength and balance exercises with a difficulty level progression by increasing weights and number of repetitions, in association with a walking plan.

FallSensing clinical tool includes a software, a pressure platform and two inertial sensors. The software includes a range of exercises based on Otago Exercise Program, including warming, balance and strength exercises. The software allows that healthcare professional prescribes a tailored exercise program according to the individual needs. During exercise performance, pressure distribution can be analysed by the healthcare professional, providing real time feedback to the individual.

02

Conditions studied

  • Accidental Falls

Keywords

  • Accidental Falls
  • Primary prevention
  • Pressure platform
  • Inertial Sensor
03

In context

Lead sponsor

Anabela Correia Martins is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • individuals with severe sensorial impairments (deafness or blindness)
  • individuals with cognitive impairments which precludes the ability to comprehend the questionnaire, functional tests and exercises included in the protocol.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Exercise group

    Exercise group, including community-dwelling adults aged 50 years or over, will perform an initial evaluation, 24 intervention sessions with FallSensing clinical tool (2 or 3 sessions per week) and a final evaluation.

    Other: FallSensing Clinical Tool

Interventions

  • OtherFallSensing Clinical Tool

    FallSensing clinical tool will be applied to a group of community-dwelling adults aged 50 years or over, including a initial evaluation, 24 intervention sessions (2 or 3 sessions per week) and a final evaluation. Inicial and final evaluation consists in 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 a questionnaire concerning self-efficacy for exercise.

06

What researchers measure

Primary outcomes

  1. Timed Up and Go

    seconds

    Time frame: Change from baseline time to perform TUG up to 12 weeks

  2. Self-efficacy for Exercise

    Score 5 to 20 points

    Time frame: Change from baseline Self-efficacy for exercise score up to 12 weeks

Secondary outcomes

  1. Grip Strength

    Kilogram-force

    Time frame: Outset and up to 12 weeks

  2. 30 seconds Sit-to-Stand

    number of stands

    Time frame: Outset and up to 12 weeks

  3. Step Test

    number of steps

    Time frame: Outset and up to 12 weeks

  4. 4 Stage Balance Test "Modified"

    last position accomplished

    Time frame: Outset and up to 12 weeks

  5. 10 meters Walking Speed

    meters per second

    Time frame: Outset and up to 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Physio Mondego
    Coimbra, 3000-098, Portugal
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03591185
Lead sponsor
Anabela Correia Martins
Collaborators
Sensing Future Technologies, Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions
Responsible party
Anabela Correia Martins (Senior Lecturer Physiotherapy Dept., Escola Superior de Tecnologia da Saúde de Coimbra) — Sponsor-investigator
First posted
Jul 19, 2018
Start date
Jul 10, 2017
Primary completion
Sep 30, 2018 (estimated)
Completion
Oct 31, 2018 (estimated)
Last update
Jul 19, 2018

Study contacts

Anabela C Martins, PhD
Contact
anabelacmartins@estescoimbra.pt
+351917973625

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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