Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Biofeedback device

    Device

    12-week exercise program performed through the device

  • Education on falls risk

    Behavioral

    Education on falls risk factors and how to minimize them

  • Medication review

    Other intervention

    Medication will be reviewed to reduce sedative drugs and minimize interactions

  • Visual and auditory screening

    Diagnostic test

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 4 interventions
Group B: Standard of CarePlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline; week 4; week 8; week 12 and then week 24

Secondary outcomes

1

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.

Time frame
Baseline; week 4; week 8; week 12 and then week 24
2

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.

Time frame
Baseline; week 4; week 8; week 12 and then week 24
3

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).

Time frame
Baseline; week 4; week 8; week 12 and then week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sword Health, SA

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: