Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People

SWORD Health

Status: Not yet enrolling

Conditions: Fall

Treatments: Other: Medication review; Diagnostic Test: Visual and auditory screening; Device: Biofeedback device; Behavioral: Education on falls risk

Study type: Interventional

Funder types: Industry

Identifiers

NCT03750500

SH-RCT-FP-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients aged over 65 years old
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

1. Patients residing in nursing homes, daycare units or assisted-living facilities
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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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

Treatment:

Behavioral: Education on falls risk

Device: Biofeedback device

Diagnostic Test: Visual and auditory screening

Other: Medication review

Standard of Care

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Education on falls risk

Diagnostic Test: Visual and auditory screening

Other: Medication review