<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/NCT04464096</url>
  </required_header>
  <id_info>
    <org_study_id>17101098</org_study_id>
    <nct_id>NCT04464096</nct_id>
  </id_info>
  <brief_title>Can Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?</brief_title>
  <official_title>Can Ankle and Foot Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Rheumatoid patients have higher fall risk than normal population. Several fall risk factors&#xD;
      were studied. No previous study investigated the role of musculoskeletal ultrasound as a&#xD;
      predictor of fall risk in rheumatoid arthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adults with rheumatoid arthritis are exposed to higher risk of fracture. Risk factors&#xD;
      included joint tenderness, fatigue, muscle weakness, impaired balance and disease activity.&#xD;
&#xD;
      Musculoskeletal ultrasound is a bed side radiographic tool that gained much attention in the&#xD;
      last decade.It can detect stuctural chnges in the musculoskeletal system even before beeing&#xD;
      detected by the x ray.&#xD;
&#xD;
      Nowadays, musculoskeletal ultrasound is a very useful tool in examining rheumatoid patients.&#xD;
&#xD;
      No previous study was done to investigate the role of musculoskeletal ultrasound as a&#xD;
      predicting factor of fall risk in rheumatoid patients.&#xD;
&#xD;
      Predicting the fall risk in such disease could help setting preventing measures to prevent&#xD;
      falls with its sequels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2018</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>range of motion</measure>
    <time_frame>1 week</time_frame>
    <description>measured clinically as normal or restricted</description>
  </primary_outcome>
  <primary_outcome>
    <measure>muscle power</measure>
    <time_frame>1 week</time_frame>
    <description>by manual testing with 5 grades where grade 5 means normal power</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sensation</measure>
    <time_frame>1 week</time_frame>
    <description>superficial sensation reported as intact or impaired</description>
  </primary_outcome>
  <primary_outcome>
    <measure>type of foot</measure>
    <time_frame>1 week</time_frame>
    <description>using the wet test . three types of feet either normal, high arched or flat feet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tenitti balance assessment tool</measure>
    <time_frame>1 week</time_frame>
    <description>The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berge Balance assessment</measure>
    <time_frame>1 week</time_frame>
    <description>It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function A score of &lt; 45 indicates individuals may be at greater risk of falling.</description>
  </primary_outcome>
  <enrollment type="Actual">101</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non</intervention_name>
    <description>non</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with Rheumatoid arthritis .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with Rheumatoid arthritis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients aged &lt; 18 years&#xD;
&#xD;
          -  Patients with lower limb disability preventing the participant from performing the&#xD;
             mobility tests,&#xD;
&#xD;
          -  Patients who were using antidepressants and sedatives.&#xD;
&#xD;
          -  Patients with severe comorbidities, severe vision impairment, or hearing loss or&#xD;
             neurological diseases that interferes with the mobility as stroke or neuropathy, were&#xD;
             also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Stanmore EK, Oldham J, Skelton DA, O'Neill T, Pilling M, Campbell AJ, Todd C. Fall incidence and outcomes of falls in a prospective study of adults with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 May;65(5):737-44. doi: 10.1002/acr.21892.</citation>
    <PMID>23139011</PMID>
  </reference>
  <reference>
    <citation>Hayashibara M, Hagino H, Katagiri H, Okano T, Okada J, Teshima R. Incidence and risk factors of falling in ambulatory patients with rheumatoid arthritis: a prospective 1-year study. Osteoporos Int. 2010 Nov;21(11):1825-33. doi: 10.1007/s00198-009-1150-4. Epub 2010 Jan 30.</citation>
    <PMID>20119662</PMID>
  </reference>
  <reference>
    <citation>Oswald AE, Pye SR, O'Neill TW, Bunn D, Gaffney K, Marshall T, Silman AJ, Symmons DP. Prevalence and associated factors for falls in women with established inflammatory polyarthritis. J Rheumatol. 2006 Apr;33(4):690-4. Epub 2006 Feb 15.</citation>
    <PMID>16482644</PMID>
  </reference>
  <reference>
    <citation>Armstrong C, Swarbrick CM, Pye SR, O'Neill TW. Occurrence and risk factors for falls in rheumatoid arthritis. Ann Rheum Dis. 2005 Nov;64(11):1602-4. doi: 10.1136/ard.2004.031195. Epub 2005 Apr 7.</citation>
    <PMID>15817660</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>safaa Mahran</investigator_full_name>
    <investigator_title>Associate Proffesor</investigator_title>
  </responsible_party>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>foot problems</keyword>
  <keyword>Fall risk</keyword>
  <keyword>predictors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All data is treated confidentially.</ipd_description>
  </patient_data>
  <!-- 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/NCT04464096
org study id: 17101098
nct id: NCT04464096
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rheumatoid patients have higher fall risk than normal population. Several fall risk factors
      were studied. No previous study investigated the role of musculoskeletal ultrasound as a
      predictor of fall risk in rheumatoid arthritis.
Adults with rheumatoid arthritis are exposed to higher risk of fracture. Risk factors
      included joint tenderness, fatigue, muscle weakness, impaired balance and disease activity.

      Musculoskeletal ultrasound is a bed side radiographic tool that gained much attention in the
      last decade.It can detect stuctural chnges in the musculoskeletal system even before beeing
      detected by the x ray.

      Nowadays, musculoskeletal ultrasound is a very useful tool in examining rheumatoid patients.

      No previous study was done to investigate the role of musculoskeletal ultrasound as a
      predicting factor of fall risk in rheumatoid patients.

      Predicting the fall risk in such disease could help setting preventing measures to prevent
      falls with its sequels.
observational model: Case-Only
time perspective: Prospective
measure: range of motion
time frame: 1 week
description: measured clinically as normal or restricted
measure: muscle power
time frame: 1 week
description: by manual testing with 5 grades where grade 5 means normal power
measure: sensation
time frame: 1 week
description: superficial sensation reported as intact or impaired
measure: type of foot
time frame: 1 week
description: using the wet test . three types of feet either normal, high arched or flat feet.
measure: Tenitti balance assessment tool
time frame: 1 week
description: The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls
measure: Berge Balance assessment
time frame: 1 week
description: It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function A score of < 45 indicates individuals may be at greater risk of falling.
intervention type: Other
intervention name: non
description: non
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Stanmore EK, Oldham J, Skelton DA, O'Neill T, Pilling M, Campbell AJ, Todd C. Fall incidence and outcomes of falls in a prospective study of adults with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 May;65(5):737-44. doi: 10.1002/acr.21892.
PMID: 23139011
citation: Hayashibara M, Hagino H, Katagiri H, Okano T, Okada J, Teshima R. Incidence and risk factors of falling in ambulatory patients with rheumatoid arthritis: a prospective 1-year study. Osteoporos Int. 2010 Nov;21(11):1825-33. doi: 10.1007/s00198-009-1150-4. Epub 2010 Jan 30.
PMID: 20119662
citation: Oswald AE, Pye SR, O'Neill TW, Bunn D, Gaffney K, Marshall T, Silman AJ, Symmons DP. Prevalence and associated factors for falls in women with established inflammatory polyarthritis. J Rheumatol. 2006 Apr;33(4):690-4. Epub 2006 Feb 15.
PMID: 16482644
citation: Armstrong C, Swarbrick CM, Pye SR, O'Neill TW. Occurrence and risk factors for falls in rheumatoid arthritis. Ann Rheum Dis. 2005 Nov;64(11):1602-4. doi: 10.1136/ard.2004.031195. Epub 2005 Apr 7.
PMID: 15817660
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: safaa Mahran
investigator title: Associate Proffesor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No
ipd description: All data is treated confidentially.