Accidental FallsNCT03591185
FallSensing Clinical Tool for Fall Risk Prevention in Community-dwelling Adults Aged 50 Years or Over
A study testing FallSensing Clinical Tool in people with Accidental Falls, run by Anabela Correia Martins 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 Falls
- What is being tested?
- FallSensing Clinical Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 10 Jul 2017to 31 Oct 2018
- 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.
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%.
Several studies recognize the benefits of the Otago Exercise Program (OEP) on physical functioning and falls reduction in older people. The program includes strength and balance exercises with a difficulty level progression by increasing weights and number of repetitions, in association with a walking plan.
FallSensing clinical tool includes a software, a pressure platform and two inertial sensors. The software includes a range of exercises based on Otago Exercise Program, including warming, balance and strength exercises. The software allows that healthcare professional prescribes a tailored exercise program according to the individual needs. During exercise performance, pressure distribution can be analysed by the healthcare professional, providing real time feedback to the individual.
- Conditions
- Accidental Falls
- Being tested
- FallSensing Clinical Tool
- Keywords
- Accidental Falls, Primary prevention, Pressure platform, Inertial Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FallSensing Clinical ToolOther
FallSensing clinical tool will be applied to a group of community-dwelling adults aged 50 years or over, including a initial evaluation, 24 intervention sessions (2 or 3 sessions per week) and a final evaluation.
Inicial and final evaluation consists in 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 group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Exercise group, including community-dwelling adults aged 50 years or over, will perform an initial evaluation, 24 intervention sessions with FallSensing clinical tool (2 or 3 sessions per week) and a final evaluation. Receives: Other: FallSensing Clinical Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go
seconds
Measured: Change from baseline time to perform TUG up to 12 weeks
Self-efficacy for Exercise
Score 5 to 20 points
Measured: Change from baseline Self-efficacy for exercise score up to 12 weeks
Secondary outcomes (5)
Grip Strength
Kilogram-force
Measured: Outset and up to 12 weeks
30 seconds Sit-to-Stand
number of stands
Measured: Outset and up to 12 weeks
Step Test
number of steps
Measured: Outset and up to 12 weeks
4 Stage Balance Test "Modified"
last position accomplished
Measured: Outset and up to 12 weeks
10 meters Walking Speed
meters per second
Measured: Outset and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start10 Jul 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anabela Correia Martins
- Sponsor type
- University, hospital or other
- Collaborators
- Sensing Future Technologies, Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions
- Responsible party
- Sponsor-investigator, Anabela Correia Martins, Escola Superior de Tecnologia da Saúde de Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591185
- Sponsor's protocol ID
- 1
- Other IDs
- POCI-01-0247-FEDER-003464
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FallSensing Clinical Tool for Fall Risk Prevention in Community-dwelling Adults Aged 50 Years or Over
- ClinicalTrials.gov ID
- NCT03591185
- Acronym / sponsor ID
- 1
- Conditions
- Accidental Falls
- Keywords
- Accidental Falls, Primary prevention, Pressure platform, Inertial Sensor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anabela Correia MartinsUniversity, hospital or other
- Collaborators
- Sensing Future Technologies, Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 19 Jul 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%.
Several studies recognize the benefits of the Otago Exercise Program (OEP) on physical functioning and falls reduction in older people. The program includes strength and balance exercises with a difficulty level progression by increasing weights and number of repetitions, in association with a walking plan.
FallSensing clinical tool includes a software, a pressure platform and two inertial sensors. The software includes a range of exercises based on Otago Exercise Program, including warming, balance and strength exercises. The software allows that healthcare professional prescribes a tailored exercise program according to the individual needs. During exercise performance, pressure distribution can be analysed by the healthcare professional, providing real time feedback to the individual.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: FallSensing Clinical ToolExercise group, including community-dwelling adults aged 50 years or over, will perform an initial evaluation, 24 intervention sessions with FallSensing clinical tool (2 or 3 sessions per week) and a final evaluation. |
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 Clinical ToolFallSensing clinical tool will be applied to a group of community-dwelling adults aged 50 years or over, including a initial evaluation, 24 intervention sessions (2 or 3 sessions per week) and a final evaluation. Inicial and final evaluation consists in 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 | Exercise group |
Primary outcome
Timed Up and Go
Time frame: Change from baseline time to perform TUG up to 12 weeks
seconds
Self-efficacy for Exercise
Time frame: Change from baseline Self-efficacy for exercise score up to 12 weeks
Score 5 to 20 points
5 secondary outcomes
Grip Strength
Time frame: Outset and up to 12 weeks
30 seconds Sit-to-Stand
Time frame: Outset and up to 12 weeks
Step Test
Time frame: Outset and up to 12 weeks
4 Stage Balance Test "Modified"
Time frame: Outset and up to 12 weeks
10 meters Walking Speed
Time frame: Outset and up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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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 Clinical Tool in people with Accidental Falls, run by Anabela Correia Martins 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 19 Jul 2018. 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?
Timed Up and Go (time frame: Change from baseline time to perform TUG up to 12 weeks). The study lists 2 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 19 Jul 2018.