FallSensing Multiplayer Games for Fall Risk Prevention in Senior Care Centers

Accidental Fall Clinical Trial

Official title:

FallSensing Multiplayer Games for Fall Risk Prevention in Senior Care Centers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03623919
• Other study ID #: 2
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: February 2019
• Source: Escola Superior de Tecnologia da Saúde de Coimbra
• Contact: Anabela C Martins, PhD
• Phone: +351917973625
• Email: anabelacmartins[@]estescoimbra.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Accidental Fall

Intervention

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.

Locations

Country	Name	City	State
Portugal	Escola Superior de Tecnologia da Saúde de Coimbra	Coimbra

Sponsors (3)

Lead Sponsor	Collaborator
Escola Superior de Tecnologia da Saúde de Coimbra	Fraunhofer Portugal AICOS, Sensing Future Technologies

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 seconds Sit-to-Stand	number of stands	Change from baseline 30 seconds Sit-to-Stand score up to 8 weeks
Primary	4 Stage Balance Test "Modified"	last position accomplished	Change from baseline 4 Stage Balance Test "Modified" score up to 8 weeks
Primary	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	Timed Up and Go	seconds	Outset and up to 8 weeks
Secondary	Grip Strength	Kilogram-force	Outset and up to 8 weeks
Secondary	Step Test	number of steps	Outset and up to 8 weeks
Secondary	10 meters Walking Speed	meters per second	Outset and up to 8 weeks