<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03750500</url>
  </required_header>
  <id_info>
    <org_study_id>SH-RCT-FP-01</org_study_id>
    <nct_id>NCT03750500</nct_id>
  </id_info>
  <brief_title>Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People</brief_title>
  <official_title>Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sword Health, SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sword Health, SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a single-center, prospective, non-blind, parallel-group, randomized controlled&#xD;
      trial with an experimental and a control group with the aim of evaluating the clinical impact&#xD;
      of a home-based falls prevention program using a new biofeedback system on community-dwellers&#xD;
      older adults with fall risk in comparison with standard of care.&#xD;
&#xD;
      The experimental group will perform a 12-week exercise program at home, under remote&#xD;
      monitoring from a clinical team, whereas the control group will benefit from standard medical&#xD;
      care currently in place at the participating primary care facility.&#xD;
&#xD;
      The hypothesis is that the home-based falls prevention program will lead to a lower risk of&#xD;
      falling than standard medical care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 2024</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the 5 Times Sit to Stand Test</measure>
    <time_frame>Baseline; week 4; week 8; week 12 and then week 24</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Timed Up and Go Test score</measure>
    <time_frame>Baseline; week 4; week 8; week 12 and then week 24</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Berg Balance Scale</measure>
    <time_frame>Baseline; week 4; week 8; week 12 and then week 24</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Shorts Falls Efficacy Scale-International</measure>
    <time_frame>Baseline; week 4; week 8; week 12 and then week 24</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Fall</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biofeedback device</intervention_name>
    <description>12-week exercise program performed through the device</description>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>SWORD Phoenix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education on falls risk</intervention_name>
    <description>Education on falls risk factors and how to minimize them</description>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medication review</intervention_name>
    <description>Medication will be reviewed to reduce sedative drugs and minimize interactions</description>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Visual and auditory screening</intervention_name>
    <description>Patients will go through visual and auditory screening as part of their regular care</description>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged over 65 years old&#xD;
&#xD;
          2. Ability to walk at least 20 meters, unaided or with unilateral support&#xD;
&#xD;
          3. Ability to understand motor complex commands&#xD;
&#xD;
          4. Mini-Mental State Examination (MMSE) score &gt; 24 points&#xD;
&#xD;
          5. Functional independence for instrumental activities of daily living&#xD;
&#xD;
          6. Risk of recurrent falls, defined as 5xSST score &gt; 15,00 seconds&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients residing in nursing homes, daycare units or assisted-living facilities&#xD;
&#xD;
          2. Aphasia, dementia or psychiatric comorbidity, significantly interfering with&#xD;
             communication or compliance with a home-based exercise program&#xD;
&#xD;
          3. Severe visual our hearing, interfering with communication or with compliance to a&#xD;
             home-based exercise program&#xD;
&#xD;
          4. Cardiac, respiratory or other condition incompatible with at least 30 minutes of light&#xD;
             to moderate physical activity&#xD;
&#xD;
          5. Osteoarticular conditions (e.g. severe osteoarthrosis), which prevent the patient from&#xD;
             complying with a home-based exercise program&#xD;
&#xD;
          6. Patients with neurologic conditions (e.g. stroke, multiple sclerosis, Parkinson's&#xD;
             disease)&#xD;
&#xD;
          7. Other medical complications, which prevent the patient from complying with a&#xD;
             home-based exercise program&#xD;
&#xD;
          8. Illiteracy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fernando Correia, MD</last_name>
    <phone>+351966557789</phone>
    <email>fanacorreia@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mariana Sant'Ana, MD</last_name>
    <phone>+351918448914</phone>
    <email>mariana.magsant@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>USF Aldoar</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
    <contact>
      <last_name>Mariana Sant'Ana</last_name>
      <phone>+351918448194</phone>
    </contact>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study protocol and study aggregate results (including anonymised individual patient data) will be made available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>The data will become available upon study publication, for 5 years.</ipd_time_frame>
    <ipd_access_criteria>The protocol will be made available through this platform.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03750500/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03750500
org study id: SH-RCT-FP-01
nct id: NCT03750500
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in the 5 Times Sit to Stand Test
time frame: Baseline; week 4; week 8; week 12 and then week 24
description: 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
measure: Change in the Timed Up and Go Test score
time frame: Baseline; week 4; week 8; week 12 and then week 24
description: 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.
measure: Change in the Berg Balance Scale
time frame: Baseline; week 4; week 8; week 12 and then week 24
description: 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.
measure: Change in the Shorts Falls Efficacy Scale-International
time frame: Baseline; week 4; week 8; week 12 and then week 24
description: 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).
arm group label: Experimental
arm group type: Experimental
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
arm group label: Standard of Care
arm group type: Placebo Comparator
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.
intervention type: Device
intervention name: Biofeedback device
description: 12-week exercise program performed through the device
arm group label: Experimental
other name: SWORD Phoenix
intervention type: Behavioral
intervention name: Education on falls risk
description: Education on falls risk factors and how to minimize them
arm group label: Experimental
arm group label: Standard of Care
intervention type: Other
intervention name: Medication review
description: Medication will be reviewed to reduce sedative drugs and minimize interactions
arm group label: Experimental
arm group label: Standard of Care
intervention type: Diagnostic Test
intervention name: Visual and auditory screening
description: Patients will go through visual and auditory screening as part of their regular care
arm group label: Experimental
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fernando Correia, MD
phone: +351966557789
email: fanacorreia@gmail.com
last name: Mariana Sant'Ana, MD
phone: +351918448914
email: mariana.magsant@gmail.com
facility: 
contact: 
country: Portugal
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Study protocol and study aggregate results (including anonymised individual patient data) will be made available
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: The data will become available upon study publication, for 5 years.
ipd access criteria: The protocol will be made available through this platform.
provided document: 