xml: <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/NCT06029361</url>
    </required_header>
    <id_info>
      <org_study_id>0003-22 MMC</org_study_id>
      <nct_id>NCT06029361</nct_id>
    </id_info>
    <brief_title>Improvement of Function After Hip Fracture in Geriatric Rehabilitation Unit Via Augmented Reality Device &quot;SELFIT&quot;</brief_title>
    <official_title>Improving Function and Mobility in Geriatric Patients After a Femoral Neck Fracture Who Are Undergoing Inpatient Rehabilitation Using an Augmented Reality Practice System - SELFIT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Meir Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Meir Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Type of study: prospective interventional the purposes of the research :To examine the effect&#xD;
        of treatment using the SELFIT system on function, walking and balance in patients after hip&#xD;
        fractures hospitalized in the geriatric rehabilitation department.&#xD;
  &#xD;
        The study population: 50 participants aged 65+ who were admitted to the geriatric&#xD;
        rehabilitation department after hip fractures, with 25 in the experimental group and 25 in&#xD;
        the control group.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  What is the effect of training with SELFIT system on the functional outcomes in patients&#xD;
             after hip fractures hospitalized in the geriatric rehabilitation department.&#xD;
  &#xD;
          -  How the training with SELFIT system will effect on satisfaction of the patients in the&#xD;
             geriatric rehabilitation department.&#xD;
  &#xD;
        During 21 days, both groups will receive physical therapy for about 45 minutes. The&#xD;
        experimental group will be allocated about 15 minutes out of the 45 minutes to practice with&#xD;
        the help of the SELFIT system.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Recruiting participants for the study:&#xD;
  &#xD;
        When admitting patients hospitalized in the geriatric rehabilitation department after hip&#xD;
        neck fractures, their suitability for participation in the study will be examined according&#xD;
        to inclusion and exclusion criteria. Patients who meet the inclusion criteria will receive an&#xD;
        explanation of the research procedure and its goals, and if they agree and are suitable in&#xD;
        terms of signature competence and cognitive ability to participate in the study, they will&#xD;
        sign an informed consent form for participation in the study.&#xD;
  &#xD;
        After signing a consent form to participate in the study, each participant will be randomly&#xD;
        assigned to an experimental group or a control group. After the patient agrees to participate&#xD;
        in the study, he will receive a number that will be assigned in sequential order, where an&#xD;
        even number means belonging to the experimental group and an odd number, belonging to the&#xD;
        control group.&#xD;
  &#xD;
        Intervention:&#xD;
  &#xD;
        During 21 days, both groups will receive physical therapy for about 45 minutes. The&#xD;
        experimental group will be allocated about 15 minutes out of the 45 minutes to practice with&#xD;
        the help of the SELFIT system.&#xD;
  &#xD;
        Both groups will receive physiotherapy treatment accepted in the geriatric rehabilitation&#xD;
        department. Patients in both groups receive treatment that focuses on improving strength in&#xD;
        the lower limbs, improving ROM, lying and standing exercises, walking with an assistive&#xD;
        device according to the patient's ability.&#xD;
  &#xD;
        In the second and third week of rehabilitation, patients progress to exercises to improve&#xD;
        walking ability, which include standing practice to improve strength and balance, walking&#xD;
        with an aid for distances according to the adjustment of walking ability, dynamic balance&#xD;
        practice on unstable surfaces and practice on stairs.&#xD;
  &#xD;
        Patients from the control group will receive standard treatment according to the patient's&#xD;
        ability and the degrees of difficulty of the exercises will progress according to the ability&#xD;
        of each patient. After the evaluation, the patients in the control group will receive an&#xD;
        exercise in bed lying down or sitting to strengthen the lower limbs for about 15 minutes, an&#xD;
        exercise in front of a bar to improve the strength of the lower limbs and the ability to&#xD;
        stand up for about 15 minutes, an exercise to improve balance and walking for about 15&#xD;
        minutes.&#xD;
  &#xD;
        Patients from the experimental group will receive exercise in bed lying down or sitting to&#xD;
        strengthen lower limbs for about 15 minutes, exercise in front of a bar to improve lower limb&#xD;
        strength and the ability to stand up for about 15 minutes, exercise in the SELFIT system of&#xD;
        balance and walking for about 15 minutes. The intervention in the SELFIT system will be&#xD;
        carried out 4 times a week by a physiotherapist in the department.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">March 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>an assessment will be made by questionnaires and an objective assessment by physiotherapists who will not be involved in the treatment of the SELFIT system in the interventional group</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Functional Independence Measure</measure>
      <time_frame>9 month</time_frame>
      <description>Measured by: Functional Independence Measure Index (FIM) that assess activity of daily living.&#xD;
  only motor assessment part is used. Minimum score 5 pts. Maximum score: 35 points.&#xD;
  Higher score means better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>5 time sit to stand</measure>
      <time_frame>9 month</time_frame>
      <description>Assessment of time performance for five time stand up and sitting on chair. Less time means better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Berg Balance Test</measure>
      <time_frame>9 month</time_frame>
      <description>Assessment of balance function by 14 tasks. Min.0 max.56 points Higher score means better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>10 Meter walk test</measure>
      <time_frame>9 month</time_frame>
      <description>Assessment of time performance of walking 10 meters. Less time means better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Falls Efficacy Scale</measure>
      <time_frame>9 month</time_frame>
      <description>Assessment of confidence of functions. Score range from 16 to 64 points. Higher score means better outcomes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>VAS - visual analog scale</measure>
      <time_frame>9 month</time_frame>
      <description>as mesured by a pain scale from 1 to 10. Lower score means better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PTPSQ-H physical therapy satisfaction questionnaire</measure>
      <time_frame>9 month</time_frame>
      <description>Hebrew approved version. 15 questions about patient satisfaction with physical therapy care. Score range about 15 to 75.&#xD;
  Higher score means better outcomes</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Hip Fractures</condition>
    <arm_group>
      <arm_group_label>SELFIT device group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>25 patients in experimental group will receive 15 minutes with the SELFIT system during the 45 minutes of physical therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>45 minutes of conventional physical therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Selfit Device group</intervention_name>
      <description>During 21 days, intervention group will receive physical therapy of 45 minutes which 15 minutes out of the 45 minutes will be with the SELFIT system</description>
      <arm_group_label>SELFIT device group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control Group</intervention_name>
      <description>Conventional physical therapy of 45 minute</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to walk independently or under supervision before the fracture&#xD;
  &#xD;
            -  Patients with full weight bearing on the operated leg according to the instructions of&#xD;
               an orthopedic surgeon (FWB - Full Weight Bearing)&#xD;
  &#xD;
            -  Patients who are able to walk with an assistive device FIM 3 and above (FIM Functional&#xD;
               independence measure)&#xD;
  &#xD;
            -  Mental competence after a comprehensive assessment by a Geriatric Specialist&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with cognitive decline following dementia or delirium&#xD;
  &#xD;
            -  Patients with complications after surgery - infection or bleeding in the surgical area&#xD;
  &#xD;
            -  Patients with previous neurological injury or current CNS disease.&#xD;
  &#xD;
            -  Patients with a previous lower limb fracture in the last 5 years.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Meir Medical Center</name>
        <address>
          <city>Kfar saba</city>
          <zip>4428163</zip>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alexander Protsenko, M.Sc.PT</last_name>
        <phone>972-9-7704326</phone>
        <email>alex.protsenko@clalit.org.il</email>
      </contact>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Meir Medical Center</investigator_affiliation>
      <investigator_full_name>Alexander Protsenko</investigator_full_name>
      <investigator_title>Head of physiotherapy of geriatric rehabilitation unit</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Hip Fractures</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029361
  org study id: 0003-22 MMC
  nct id: NCT06029361
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Type of study: prospective interventional the purposes of the research :To examine the effect
        of treatment using the SELFIT system on function, walking and balance in patients after hip
        fractures hospitalized in the geriatric rehabilitation department.
  
        The study population: 50 participants aged 65+ who were admitted to the geriatric
        rehabilitation department after hip fractures, with 25 in the experimental group and 25 in
        the control group.
  
        The main question[s] it aims to answer are:
  
          -  What is the effect of training with SELFIT system on the functional outcomes in patients
             after hip fractures hospitalized in the geriatric rehabilitation department.
  
          -  How the training with SELFIT system will effect on satisfaction of the patients in the
             geriatric rehabilitation department.
  
        During 21 days, both groups will receive physical therapy for about 45 minutes. The
        experimental group will be allocated about 15 minutes out of the 45 minutes to practice with
        the help of the SELFIT system.
  Recruiting participants for the study:
  
        When admitting patients hospitalized in the geriatric rehabilitation department after hip
        neck fractures, their suitability for participation in the study will be examined according
        to inclusion and exclusion criteria. Patients who meet the inclusion criteria will receive an
        explanation of the research procedure and its goals, and if they agree and are suitable in
        terms of signature competence and cognitive ability to participate in the study, they will
        sign an informed consent form for participation in the study.
  
        After signing a consent form to participate in the study, each participant will be randomly
        assigned to an experimental group or a control group. After the patient agrees to participate
        in the study, he will receive a number that will be assigned in sequential order, where an
        even number means belonging to the experimental group and an odd number, belonging to the
        control group.
  
        Intervention:
  
        During 21 days, both groups will receive physical therapy for about 45 minutes. The
        experimental group will be allocated about 15 minutes out of the 45 minutes to practice with
        the help of the SELFIT system.
  
        Both groups will receive physiotherapy treatment accepted in the geriatric rehabilitation
        department. Patients in both groups receive treatment that focuses on improving strength in
        the lower limbs, improving ROM, lying and standing exercises, walking with an assistive
        device according to the patient's ability.
  
        In the second and third week of rehabilitation, patients progress to exercises to improve
        walking ability, which include standing practice to improve strength and balance, walking
        with an aid for distances according to the adjustment of walking ability, dynamic balance
        practice on unstable surfaces and practice on stairs.
  
        Patients from the control group will receive standard treatment according to the patient's
        ability and the degrees of difficulty of the exercises will progress according to the ability
        of each patient. After the evaluation, the patients in the control group will receive an
        exercise in bed lying down or sitting to strengthen the lower limbs for about 15 minutes, an
        exercise in front of a bar to improve the strength of the lower limbs and the ability to
        stand up for about 15 minutes, an exercise to improve balance and walking for about 15
        minutes.
  
        Patients from the experimental group will receive exercise in bed lying down or sitting to
        strengthen lower limbs for about 15 minutes, exercise in front of a bar to improve lower limb
        strength and the ability to stand up for about 15 minutes, exercise in the SELFIT system of
        balance and walking for about 15 minutes. The intervention in the SELFIT system will be
        carried out 4 times a week by a physiotherapist in the department.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: an assessment will be made by questionnaires and an objective assessment by physiotherapists who will not be involved in the treatment of the SELFIT system in the interventional group
  measure: Functional Independence Measure
  time frame: 9 month
  description: Measured by: Functional Independence Measure Index (FIM) that assess activity of daily living.
  only motor assessment part is used. Minimum score 5 pts. Maximum score: 35 points.
  Higher score means better outcome
  measure: 5 time sit to stand
  time frame: 9 month
  description: Assessment of time performance for five time stand up and sitting on chair. Less time means better outcome
  measure: Berg Balance Test
  time frame: 9 month
  description: Assessment of balance function by 14 tasks. Min.0 max.56 points Higher score means better outcome.
  measure: 10 Meter walk test
  time frame: 9 month
  description: Assessment of time performance of walking 10 meters. Less time means better outcome
  measure: Falls Efficacy Scale
  time frame: 9 month
  description: Assessment of confidence of functions. Score range from 16 to 64 points. Higher score means better outcomes
  measure: VAS - visual analog scale
  time frame: 9 month
  description: as mesured by a pain scale from 1 to 10. Lower score means better outcome
  measure: PTPSQ-H physical therapy satisfaction questionnaire
  time frame: 9 month
  description: Hebrew approved version. 15 questions about patient satisfaction with physical therapy care. Score range about 15 to 75.
  Higher score means better outcomes
  arm group label: SELFIT device group
  arm group type: Experimental
  description: 25 patients in experimental group will receive 15 minutes with the SELFIT system during the 45 minutes of physical therapy
  arm group label: Control Group
  arm group type: Active Comparator
  description: 45 minutes of conventional physical therapy
  intervention type: Device
  intervention name: Selfit Device group
  description: During 21 days, intervention group will receive physical therapy of 45 minutes which 15 minutes out of the 45 minutes will be with the SELFIT system
  arm group label: SELFIT device group
  intervention type: Other
  intervention name: Control Group
  description: Conventional physical therapy of 45 minute
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Israel
  responsible party type: Principal Investigator
  investigator affiliation: Meir Medical Center
  investigator full name: Alexander Protsenko
  investigator title: Head of physiotherapy of geriatric rehabilitation unit
  mesh term: Fractures, Bone
  mesh term: Hip Fractures