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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03750500
Recruitment Status : Not yet recruiting
First Posted : November 23, 2018
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Sword Health, SA

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Fall Device: Biofeedback device Behavioral: Education on falls risk Other: Medication review Diagnostic Test: Visual and auditory screening Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People - a Randomized Controlled Trial
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Device: Biofeedback device
12-week exercise program performed through the device
Other Name: SWORD Phoenix

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
Placebo Comparator: 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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Change in the 5 Times Sit to Stand Test [ Time Frame: Baseline; week 4; week 8; week 12 and then week 24 ]
    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


Secondary Outcome Measures :
  1. Change in the Timed Up and Go Test score [ Time Frame: Baseline; week 4; week 8; week 12 and then week 24 ]
    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.

  2. Change in the Berg Balance Scale [ Time Frame: Baseline; week 4; week 8; week 12 and then week 24 ]
    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.

  3. Change in the Shorts Falls Efficacy Scale-International [ Time Frame: Baseline; week 4; week 8; week 12 and then week 24 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750500


Contacts
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Contact: Fernando Correia, MD +351966557789 fanacorreia@gmail.com
Contact: Mariana Sant'Ana, MD +351918448914 mariana.magsant@gmail.com

Locations
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Portugal
USF Aldoar
Porto, Portugal
Contact: Mariana Sant'Ana    +351918448194      
Sponsors and Collaborators
Sword Health, SA
  Study Documents (Full-Text)

Documents provided by Sword Health, SA:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] November 14, 2018

More Information
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Responsible Party: Sword Health, SA
ClinicalTrials.gov Identifier: NCT03750500    
Other Study ID Numbers: SH-RCT-FP-01
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol and study aggregate results (including anonymised individual patient data) will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The data will become available upon study publication, for 5 years.
Access Criteria: The protocol will be made available through this platform.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No