Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People
ConditionFall
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSword Health, SA
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Biofeedback device
- Education on falls risk
- Medication review
- Visual and auditory screening
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov