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

NCT03750500 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-06

No results posted yet for this study

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 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

Interventions

DEVICE

Biofeedback device

12-week exercise program performed through the device

BEHAVIORAL

Education on falls risk

Education on falls risk factors and how to minimize them

OTHER

Medication review

Medication will be reviewed to reduce sedative drugs and minimize interactions

DIAGNOSTIC_TEST

Visual and auditory screening

Patients will go through visual and auditory screening as part of their regular care

Sponsors & Collaborators

  • Sword Health, SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-08-31
Completion
2026-11-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03750500 on ClinicalTrials.gov