FallSensing Multiplayer Games for Fall Risk Prevention in Senior Care Centers

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%.

The FallSensing games software include 3 mini-games to be played by two teams with up to 3 players each will compete against each other alternately.

The players will perform an initial evaluation with FallSensing screening tool, 16 sessions of group games (2 times a week/8weeks) with FallSensing multiplayer games and a final evaluation also with FallSensing screening tool.

Both initial and final evaluation include 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.

Study Overview

• Status: Unknown
• Conditions: Accidental Fall
• Intervention / Treatment: Other: FallSensing multiplayer games

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

Contacts and Locations

Study Locations

• Portugal
  • Coimbra, Portugal, 3040-162
    • Recruiting
    • Escola Superior de Tecnologia da Saúde de Coimbra

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: Prevention
• 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; Group games, including two teams of seniors aged 50 years or older. The FallSensing games software include 3 mini-games to be played by two teams with up to 3 players each will compete against each other alternately. The players will perform an initial evaluation with FallSensing screening tool, 16 sessions of group games (2 times a week/8weeks) with FallSensing multiplayer games and a final evaluation also with FallSensing screening tool. Both initial and final evaluation include 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.

Other: FallSensing multiplayer games; FallSensing multiplayer games is a technological solution based on an interactive (exer)game. Players will wear a strap on the lower limbs contaning an inertial sensor. This device enables movement identification on the characterization in real time, triggering actions in the game. The exercise games are based on a validated fall prevention exercise plan - the Otago Exercise Programme. The exercises were designed to promote mobility and improve muscle strength and balance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 seconds Sit-to-Stand	number of stands	Change from baseline 30 seconds Sit-to-Stand score up to 8 weeks
4 Stage Balance Test "Modified"	last position accomplished	Change from baseline 4 Stage Balance Test "Modified" score up to 8 weeks
Self-efficacy for Exercise	Score 5 to 20 points (the higher the score, the better Self-efficacy)	Change from baseline Self-efficacy for exercise score up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go	seconds	Outset and up to 8 weeks
Grip Strength	Kilogram-force	Outset and up to 8 weeks
Step Test	number of steps	Outset and up to 8 weeks
10 meters Walking Speed	meters per second	Outset and up to 8 weeks

Collaborators and Investigators

• Sponsor: Escola Superior de Tecnologia da Saúde de Coimbra
• Collaborators: Sensing Future Technologies; Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): October 31, 2019

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Drug and device information, study documents

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