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

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.

Study Overview

• Status: Unknown
• Conditions: Accidental Falls
• Intervention / Treatment: Other: FallSensing Clinical Tool

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anabela C Martins, PhD; Phone Number: +351917973625; Email: anabelacmartins@estescoimbra.pt

Study Locations

• Portugal
  • Coimbra, Portugal, 3000-098
    • Recruiting
    • Physio Mondego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go	seconds	Change from baseline time to perform TUG up to 12 weeks
Self-efficacy for Exercise	Score 5 to 20 points	Change from baseline Self-efficacy for exercise score up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip Strength	Kilogram-force	Outset and up to 12 weeks
30 seconds Sit-to-Stand	number of stands	Outset and up to 12 weeks
Step Test	number of steps	Outset and up to 12 weeks
4 Stage Balance Test "Modified"	last position accomplished	Outset and up to 12 weeks
10 meters Walking Speed	meters per second	Outset and up to 12 weeks

Collaborators and Investigators

• Sponsor: Anabela Correia Martins
• Collaborators: Sensing Future Technologies; Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Anticipated): September 30, 2018
• Study Completion (Anticipated): October 31, 2018

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: July 8, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 8, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Primary prevention; Accidental Falls; Pressure platform; Inertial Sensor
• Other Study ID Numbers: 1; POCI-01-0247-FEDER-003464 (Other Grant/Funding Number: Co-funded by Portugal 2020 framed under the COMPETE 2020 and European Regional Development Fund (ERDF) from EU.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No