Accidental FallNCT03623919
FallSensing Multiplayer Games for Fall Risk Prevention in Senior Care Centers
A study testing FallSensing multiplayer games in people with Accidental Fall, run by Escola Superior de Tecnologia da Saúde de Coimbra at 1 site in Portugal.
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%. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall
- What is being tested?
- FallSensing multiplayer games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2017to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Escola Superior de Tecnologia da Saúde de Coimbra
Coimbra, 3040-162
About this study
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.
Read more
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.
- Conditions
- Accidental Fall
- Being tested
- FallSensing multiplayer games
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FallSensing multiplayer gamesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: FallSensing multiplayer games |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 seconds Sit-to-Stand
number of stands
Measured: Change from baseline 30 seconds Sit-to-Stand score up to 8 weeks
4 Stage Balance Test "Modified"
last position accomplished
Measured: 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)
Measured: Change from baseline Self-efficacy for exercise score up to 8 weeks
Secondary outcomes (4)
Timed Up and Go
seconds
Measured: Outset and up to 8 weeks
Grip Strength
Kilogram-force
Measured: Outset and up to 8 weeks
Step Test
number of steps
Measured: Outset and up to 8 weeks
10 meters Walking Speed
meters per second
Measured: Outset and up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Mar 2017
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde de Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Sensing Future Technologies, Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions
- Responsible party
- Principal investigator, Anabela Correia Martins, Escola Superior de Tecnologia da Saúde de Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623919
- Sponsor's protocol ID
- 2
- Status last verified
- Feb 2019
- First submitted
- 6 Aug 2018
- Last updated
- 7 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FallSensing Multiplayer Games for Fall Risk Prevention in Senior Care Centers
- ClinicalTrials.gov ID
- NCT03623919
- Acronym / sponsor ID
- 2
- Conditions
- Accidental Fall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde de CoimbraUniversity, hospital or other
- Collaborators
- Sensing Future Technologies, Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: FallSensing multiplayer gamesGroup 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FallSensing multiplayer gamesFallSensing 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. | Other | Exercise group |
Primary outcome
30 seconds Sit-to-Stand
Time frame: Change from baseline 30 seconds Sit-to-Stand score up to 8 weeks
number of stands
4 Stage Balance Test "Modified"
Time frame: Change from baseline 4 Stage Balance Test "Modified" score up to 8 weeks
last position accomplished
Self-efficacy for Exercise
Time frame: Change from baseline Self-efficacy for exercise score up to 8 weeks
Score 5 to 20 points (the higher the score, the better Self-efficacy)
4 secondary outcomes
Timed Up and Go
Time frame: Outset and up to 8 weeks
Grip Strength
Time frame: Outset and up to 8 weeks
Step Test
Time frame: Outset and up to 8 weeks
10 meters Walking Speed
Time frame: Outset and up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FallSensing multiplayer games in people with Accidental Fall, run by Escola Superior de Tecnologia da Saúde de Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anabela C Martins, PhD (+351917973625, anabelacmartins@estescoimbra.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 seconds Sit-to-Stand (time frame: Change from baseline 30 seconds Sit-to-Stand score up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.