FallNCT03750500
Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People
A study testing Biofeedback device, Education on falls risk and Medication review in people with Fall, run by Sword Health, SA at 1 site in Portugal.
Trial summary
This study is a single-center, prospective, non-blind, parallel-group, randomized controlled trial with an experimental and a control group with the aim of evaluating the clinical impact of a home-based falls prevention program using a new biofeedback system on community-dwellers older adults with fall risk in… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Biofeedback device, Education on falls risk and Medication review
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- May 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients aged over 65 years old
- Ability to walk at least 20 meters, unaided or with unilateral support
- Ability to understand motor complex commands
- Mini-Mental State Examination (MMSE) score > 24 points
- Functional independence for instrumental activities of daily living
- Risk of recurrent falls, defined as 5xSST score > 15,00 seconds
Who cannot join
- Patients residing in nursing homes, daycare units or assisted-living facilities
- Aphasia, dementia or psychiatric comorbidity, significantly interfering with communication or compliance with a home-based exercise program
- Severe visual our hearing, interfering with communication or with compliance to a home-based exercise program
- Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity
- Osteoarticular conditions (e.g. severe osteoarthrosis), which prevent the patient from complying with a home-based exercise program
- Patients with neurologic conditions (e.g. stroke, multiple sclerosis, Parkinson's disease)
- Other medical complications, which prevent the patient from complying with a home-based exercise program
- Illiteracy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People - a Randomized Controlled Trial
This study is a single-center, prospective, non-blind, parallel-group, randomized controlled trial with an experimental and a control group with the aim of evaluating the clinical impact of a home-based falls prevention program using a new biofeedback system on community-dwellers older adults with fall risk in comparison with standard of care.
The experimental group will perform a 12-week exercise program at home, under remote monitoring from a clinical team, whereas the control group will benefit from standard medical care currently in place at the participating primary care facility.
The hypothesis is that the home-based falls prevention program will lead to a lower risk of falling than standard medical care.
- Conditions
- Fall
- Being tested
- Biofeedback device, Education on falls risk, Medication review, Visual and auditory screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback deviceDevice
Also called SWORD Phoenix
12-week exercise program performed through the device
Education on falls riskBehavioural
Education on falls risk factors and how to minimize them
Medication reviewOther
Medication will be reviewed to reduce sedative drugs and minimize interactions
Visual and auditory screeningDiagnostic test
Patients will go through visual and auditory screening as part of their regular care
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants included in this arm will benefit from a 12-week exercise program using the novel biofeedback rehabilitation device, under remote monitoring from a physical therapist Receives: Device: Biofeedback device; Behavioral: Education on falls risk; Other: Medication review; Diagnostic Test: Visual and auditory screening |
| Standard of Care | Placebo comparator | Patients included in this arm will benefit from the standard of care currently in place in the Primary Care facility: education on risk factors for falls, medication review, visual and auditory acuity screening. Receives: Behavioral: Education on falls risk; Other: Medication review; Diagnostic Test: Visual and auditory screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the 5 Times Sit to Stand Test
The 5 Times Sit to Stand Test is a performance test that measures the strength and the lower limb mobility. It consists of the time it takes to stand up from a chair five consecutive times. A cutoff value of 15 seconds is used to distinguish between individuals with and without risk of recurrent falls
Measured: Baseline; week 4; week 8; week 12 and then week 24
Secondary outcomes (3)
Change in the Timed Up and Go Test score
The TUG is a performance test that assesses the mobility, balance and gait in elderly individuals, consisting of the time it takes to stand up from a chair, walk 3 meters, turn around, come back and sit down again.
Measured: Baseline; week 4; week 8; week 12 and then week 24
Change in the Berg Balance Scale
The Berg Balance Scale was developed to evaluate the static and dynamic balance in three domains: sitting, standing and changing posture. It is a scale composed of 14 items graded by an external observer on 5 levels (from 0 to 4). Scale scores range from 0 to 56, with higher scores representing a higher level of functionality.
Measured: Baseline; week 4; week 8; week 12 and then week 24
Change in the Shorts Falls Efficacy Scale-International
The Shorts Falls Efficacy Scale-International was developed in order to systematize on a scale the fear of falling. It is a questionnaire of 7 items filled by the user, evaluating from 1 to 4 the fear of falling during the execution of a series of activities of daily living. It is a standardized and comparable measure over time, which provides an additional dimension in the characterization of participants. The cutoff levels are: low fear (7-8); moderate fear (9-13) and high fear (14-28).
Measured: Baseline; week 4; week 8; week 12 and then week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study startMay 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sword Health, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750500
- Sponsor's protocol ID
- SH-RCT-FP-01
- Status last verified
- Dec 2024
- First submitted
- 20 Nov 2018
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and study aggregate results (including anonymised individual patient data) will be made available
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03750500
- Acronym / sponsor ID
- SH-RCT-FP-01
- Conditions
- Fall
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sword Health, SAIndustry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 23 Nov 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.
This study is a single-center, prospective, non-blind, parallel-group, randomized controlled trial with an experimental and a control group with the aim of evaluating the clinical impact of a home-based falls prevention program using a new biofeedback system on community-dwellers older adults with fall risk in comparison with standard of care.
The experimental group will perform a 12-week exercise program at home, under remote monitoring from a clinical team, whereas the control group will benefit from standard medical care currently in place at the participating primary care facility.
The hypothesis is that the home-based falls prevention program will lead to a lower risk of falling than standard medical care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Biofeedback device, Behavioral: Education on falls risk, Other: Medication review, Diagnostic Test: Visual and auditory screeningParticipants included in this arm will benefit from a 12-week exercise program using the novel biofeedback rehabilitation device, under remote monitoring from a physical therapist |
| Standard of Care | Placebo comparator | Behavioral: Education on falls risk, Other: Medication review, Diagnostic Test: Visual and auditory screeningPatients included in this arm will benefit from the standard of care currently in place in the Primary Care facility: education on risk factors for falls, medication review, visual and auditory acuity screening. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patients aged over 65 years old
- Ability to walk at least 20 meters, unaided or with unilateral support
- Ability to understand motor complex commands
- Mini-Mental State Examination (MMSE) score > 24 points
- Functional independence for instrumental activities of daily living
Key exclusion criteria (8 listed)
- Patients residing in nursing homes, daycare units or assisted-living facilities
- Aphasia, dementia or psychiatric comorbidity, significantly interfering with communication or compliance with a home-based exercise program
- Severe visual our hearing, interfering with communication or with compliance to a home-based exercise program
- Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity
- Osteoarticular conditions (e.g. severe osteoarthrosis), which prevent the patient from complying with a home-based exercise program
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 |
|---|---|---|
| Biofeedback deviceAlso: SWORD Phoenix12-week exercise program performed through the device | Device | Experimental |
| Education on falls riskEducation on falls risk factors and how to minimize them | Behavioural | Experimental, Standard of Care |
| Medication reviewMedication will be reviewed to reduce sedative drugs and minimize interactions | Other | Experimental, Standard of Care |
| Visual and auditory screeningPatients will go through visual and auditory screening as part of their regular care | Diagnostic test | Experimental, Standard of Care |
Primary outcome
Change in the 5 Times Sit to Stand Test
Time frame: Baseline; week 4; week 8; week 12 and then week 24
The 5 Times Sit to Stand Test is a performance test that measures the strength and the lower limb mobility. It consists of the time it takes to stand up from a chair five consecutive times. A cutoff value of 15 seconds is used to distinguish between individuals with and without risk of recurrent falls
3 secondary outcomes
Change in the Timed Up and Go Test score
Time frame: Baseline; week 4; week 8; week 12 and then week 24
Change in the Berg Balance Scale
Time frame: Baseline; week 4; week 8; week 12 and then week 24
Change in the Shorts Falls Efficacy Scale-International
Time frame: Baseline; week 4; week 8; week 12 and then week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Yes. Study protocol and study aggregate results (including anonymised individual patient data) will be made available
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback device, Education on falls risk and Medication review in people with Fall, run by Sword Health, SA 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando Correia, MD (+351966557789, fanacorreia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 5 Times Sit to Stand Test (time frame: Baseline; week 4; week 8; week 12 and then week 24). 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 6 Dec 2024.