NCT03623919

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

2.6 years

First QC Date

August 6, 2018

Last Update Submit

February 6, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Timed Up and Go

    Outset and up to 8 weeks

  • Grip Strength

    Outset and up to 8 weeks

  • Step Test

    Outset and up to 8 weeks

  • 10 meters Walking Speed

    Outset and up to 8 weeks

Study Arms (1)

Exercise group

EXPERIMENTAL

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

Interventions

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.

Exercise group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Tecnologia da Saúde de Coimbra

Coimbra, 3040-162, Portugal

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer Physiotherapy Dept.

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 9, 2018

Study Start

March 1, 2017

Primary Completion

September 30, 2019

Study Completion

October 31, 2019

Last Updated

February 7, 2019

Record last verified: 2019-02

Locations