Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People
NCT ID: NCT03750500
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-05-31
2026-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
Biofeedback device
12-week exercise program performed through the device
Education on falls risk
Education on falls risk factors and how to minimize them
Medication review
Medication will be reviewed to reduce sedative drugs and minimize interactions
Visual and auditory screening
Patients will go through visual and auditory screening as part of their regular care
Standard of Care
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.
Education on falls risk
Education on falls risk factors and how to minimize them
Medication review
Medication will be reviewed to reduce sedative drugs and minimize interactions
Visual and auditory screening
Patients will go through visual and auditory screening as part of their regular care
Interventions
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Biofeedback device
12-week exercise program performed through the device
Education on falls risk
Education on falls risk factors and how to minimize them
Medication review
Medication will be reviewed to reduce sedative drugs and minimize interactions
Visual and auditory screening
Patients will go through visual and auditory screening as part of their regular care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Ability to walk at least 20 meters, unaided or with unilateral support
3. Ability to understand motor complex commands
4. Mini-Mental State Examination (MMSE) score \> 24 points
5. Functional independence for instrumental activities of daily living
6. Risk of recurrent falls, defined as 5xSST score \> 15,00 seconds
Exclusion Criteria
2. Aphasia, dementia or psychiatric comorbidity, significantly interfering with communication or compliance with a home-based exercise program
3. Severe visual our hearing, interfering with communication or with compliance to a home-based exercise program
4. Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity
5. Osteoarticular conditions (e.g. severe osteoarthrosis), which prevent the patient from complying with a home-based exercise program
6. Patients with neurologic conditions (e.g. stroke, multiple sclerosis, Parkinson's disease)
7. Other medical complications, which prevent the patient from complying with a home-based exercise program
8. Illiteracy
65 Years
ALL
Yes
Sponsors
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Sword Health, SA
INDUSTRY
Responsible Party
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Locations
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USF Aldoar
Porto, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Mariana Sant'Ana
Role: primary
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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SH-RCT-FP-01
Identifier Type: -
Identifier Source: org_study_id