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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03623919
Other study ID # 2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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