<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/NCT04433962</url>
  </required_header>
  <id_info>
    <org_study_id>2012/22-01</org_study_id>
    <nct_id>NCT04433962</nct_id>
  </id_info>
  <brief_title>Investigation of the Effects of Balance Training on Balance and Functional Status Patients With Total Hip Arthroplasty</brief_title>
  <official_title>Investigation of the Effects of Balance Training on Balance and Functional Status Patients With Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege 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>
      The purpose of this study is to investigate the effects of balance training in patients with&#xD;
      THA until 26 weeks postoperatively. Thirty-two patients with hip osteoarthritis who were&#xD;
      candidates for THA were recruited to the study. Sixteen patients with THA completed the study&#xD;
      protocol and the patients were randomized into 2 groups: conventional rehabilitation (CR,&#xD;
      n=8) or conventional rehabilitation plus balance training (CR + BT, n=8) groups. The patients&#xD;
      were evaluated by hand-held dynamometer, single leg stance test (SLST), Tetrax balance&#xD;
      system, Harris hip score, lower extremity function scale, 5 times sit-to-stand test and 50&#xD;
      foot timed walk test preoperatively and in the 8th, 14th and 26th weeks postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">December 25, 2016</completion_date>
  <primary_completion_date type="Actual">October 20, 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>single leg test</measure>
    <time_frame>Pre-op to post-op 26. week</time_frame>
    <description>Patients were tested first with eyes opened and then with eyes closed; they were asked to stand on either their left or right leg and tried to keep their legs from touching and to maintain single-leg stance for as long as possible. The test and time began once the foot was lifted off the floor, and ended when placing the lifted foot on the floor or with arm movements. The test was terminated following a maximum of 45 s, and each leg was tested three times with eyes opened and eyes closed and the best of the three trials were recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tetrax Balance Assessment</measure>
    <time_frame>Pre-op to post-op 26. week</time_frame>
    <description>Tetrax Balance Assessment System (Sunlight Medical Ltd.Ramat Gan, Israel); is a valid, reliable and objective method to evaluate balance and fall risk. The system obtains data by using 4 different platforms which measure vertical pressure fluctuations arising from two heels and two fingertips. Patients were instructed an immobile posture for 32 s for each of the eight sensory conditions.The fall risks of the patients were calculated as percentage (%) by a posturographic program considering the oscillation rates. A value between 0% and 36% is judged as mild risk; a value between 37% and 58%, as moderate risk; and between 59% and 100%, as high risk. The higher score is showed the greater falling risk</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sit to stand test</measure>
    <time_frame>Pre-op to post-op 26. week</time_frame>
    <description>STS; is an objective functional measure of strength correlating with ambulatory independence. Sit-to-stand (such as the 5 STS) activities are recommended as the minimal core set of performance-based outcome measures in OA research and clinical practice [21]. Patients sit on a height adjustable chair such that a 90⁰ angle is formed when the femur is horizontal and tibia vertical with their feet shoulder width apart and their arms crossed against their chest. Patients are timed as they 5 times stand up from chair and sit down again without using their hand, time was recorded as second</description>
  </primary_outcome>
  <primary_outcome>
    <measure>50 feet walk test</measure>
    <time_frame>Pre-op to post-op 26. week</time_frame>
    <description>50 FWT; is a reliable measurement method and commonly used in studies of exercise based OA. All patients are asked to walk as quickly as possible in 50 feet length distance. The physiotherapist counted number of steps and as soon as the patient finished to walking 50 feet length distance and the time was recorded as seconds</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Harris hip score</measure>
    <time_frame>Pre-op to post-op 26. week</time_frame>
    <description>Many different hip scoring scales are used in assessment of THA's results [23]. HHS is a joint specific outcome measurements and the most frequently used in assessment of THA patients. It has been used in a number of studies over the years and has been shown to have high validity and reliability [23,24]. HHS was recorded, a score commonly used in this context, which contains questions about pain, function, absence of deformity, and range-of-motion. The best possible score is 100 points</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lower extremity function scale</measure>
    <time_frame>Pre-op to post-op 26. week</time_frame>
    <description>is a region specific measure, was conceived to assess the lower extremity functional status of patients and the reliability estimates have been high when investigated in the THA and TKA population. The LEFS is composed of 20 items each scored on a 5 point adjectival scale with '0' extreme difficulty or unable to perform the activity and '4' no difficulty. The items are summed to produce a total LEFS score, which can vary from 0 to 80.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>Pre-op to post-op 26. week</time_frame>
    <description>Visual analog scale was used to determine to degree of pain. The patient was asked to choose a number 0 and 10 on a chart. 0 indicates &quot;no pain&quot; and 10 indicates &quot;very severe pain&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion</measure>
    <time_frame>Pre-op to post-op 26. week</time_frame>
    <description>Hip extension, hipflexion, hip abduction and hip adduction was measured with goniometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>Pre-op to post-op 26. week</time_frame>
    <description>Maximal isometric muscle strength was measured with a handheld dynamometer (HHD) (Lafayette Instrument Company).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Arthroplasty Complications</condition>
  <condition>Physical Disability</condition>
  <condition>Osteoarthritis, Hip</condition>
  <arm_group>
    <arm_group_label>conventional rehabilitation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the conventional rehabilitation group completed hip joint range of motion and muscle strengthening exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional rehabilitation + balance training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The conventional rehabilitation + balance training group completed hip joint range of motion and muscle strengthening exercises and 12 balance exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise training</intervention_name>
    <arm_group_label>conventional rehabilitation + balance training group</arm_group_label>
    <arm_group_label>conventional rehabilitation group</arm_group_label>
    <other_name>conventional rehabilitation</other_name>
    <other_name>conventional rehabilitation and balance training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Total hip arthroplasty due to osteoarthritis&#xD;
&#xD;
          -  First time hip surgery/prothesis&#xD;
&#xD;
          -  no involvement in any exercise program in the past 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  THA due to hip fracture,&#xD;
&#xD;
          -  revision hip prothesis,&#xD;
&#xD;
          -  arthritis in other joints limited function&#xD;
&#xD;
          -  neurologic problems that limited function and balance,&#xD;
&#xD;
          -  body mass index greater than 40 kg/m2.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nuray Elibol, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ege University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dokuz Eylul University</name>
      <address>
        <city>Izmir</city>
        <state>Bornova</state>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Nuray Elibol</investigator_full_name>
    <investigator_title>Assistant of Professor</investigator_title>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <keyword>hip</keyword>
  <keyword>total hip arthroplasty</keyword>
  <keyword>balance training</keyword>
  <keyword>function</keyword>
  <keyword>assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04433962
org study id: 2012/22-01
nct id: NCT04433962
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the effects of balance training in patients with
      THA until 26 weeks postoperatively. Thirty-two patients with hip osteoarthritis who were
      candidates for THA were recruited to the study. Sixteen patients with THA completed the study
      protocol and the patients were randomized into 2 groups: conventional rehabilitation (CR,
      n=8) or conventional rehabilitation plus balance training (CR + BT, n=8) groups. The patients
      were evaluated by hand-held dynamometer, single leg stance test (SLST), Tetrax balance
      system, Harris hip score, lower extremity function scale, 5 times sit-to-stand test and 50
      foot timed walk test preoperatively and in the 8th, 14th and 26th weeks postoperatively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: single leg test
time frame: Pre-op to post-op 26. week
description: Patients were tested first with eyes opened and then with eyes closed; they were asked to stand on either their left or right leg and tried to keep their legs from touching and to maintain single-leg stance for as long as possible. The test and time began once the foot was lifted off the floor, and ended when placing the lifted foot on the floor or with arm movements. The test was terminated following a maximum of 45 s, and each leg was tested three times with eyes opened and eyes closed and the best of the three trials were recorded
measure: Tetrax Balance Assessment
time frame: Pre-op to post-op 26. week
description: Tetrax Balance Assessment System (Sunlight Medical Ltd.Ramat Gan, Israel); is a valid, reliable and objective method to evaluate balance and fall risk. The system obtains data by using 4 different platforms which measure vertical pressure fluctuations arising from two heels and two fingertips. Patients were instructed an immobile posture for 32 s for each of the eight sensory conditions.The fall risks of the patients were calculated as percentage (%) by a posturographic program considering the oscillation rates. A value between 0% and 36% is judged as mild risk; a value between 37% and 58%, as moderate risk; and between 59% and 100%, as high risk. The higher score is showed the greater falling risk
measure: Sit to stand test
time frame: Pre-op to post-op 26. week
description: STS; is an objective functional measure of strength correlating with ambulatory independence. Sit-to-stand (such as the 5 STS) activities are recommended as the minimal core set of performance-based outcome measures in OA research and clinical practice [21]. Patients sit on a height adjustable chair such that a 90⁰ angle is formed when the femur is horizontal and tibia vertical with their feet shoulder width apart and their arms crossed against their chest. Patients are timed as they 5 times stand up from chair and sit down again without using their hand, time was recorded as second
measure: 50 feet walk test
time frame: Pre-op to post-op 26. week
description: 50 FWT; is a reliable measurement method and commonly used in studies of exercise based OA. All patients are asked to walk as quickly as possible in 50 feet length distance. The physiotherapist counted number of steps and as soon as the patient finished to walking 50 feet length distance and the time was recorded as seconds
measure: Harris hip score
time frame: Pre-op to post-op 26. week
description: Many different hip scoring scales are used in assessment of THA's results [23]. HHS is a joint specific outcome measurements and the most frequently used in assessment of THA patients. It has been used in a number of studies over the years and has been shown to have high validity and reliability [23,24]. HHS was recorded, a score commonly used in this context, which contains questions about pain, function, absence of deformity, and range-of-motion. The best possible score is 100 points
measure: Lower extremity function scale
time frame: Pre-op to post-op 26. week
description: is a region specific measure, was conceived to assess the lower extremity functional status of patients and the reliability estimates have been high when investigated in the THA and TKA population. The LEFS is composed of 20 items each scored on a 5 point adjectival scale with '0' extreme difficulty or unable to perform the activity and '4' no difficulty. The items are summed to produce a total LEFS score, which can vary from 0 to 80.
measure: Pain assessment
time frame: Pre-op to post-op 26. week
description: Visual analog scale was used to determine to degree of pain. The patient was asked to choose a number 0 and 10 on a chart. 0 indicates "no pain" and 10 indicates "very severe pain".
measure: Range of motion
time frame: Pre-op to post-op 26. week
description: Hip extension, hipflexion, hip abduction and hip adduction was measured with goniometer.
measure: Muscle strength
time frame: Pre-op to post-op 26. week
description: Maximal isometric muscle strength was measured with a handheld dynamometer (HHD) (Lafayette Instrument Company).
arm group label: conventional rehabilitation group
arm group type: Active Comparator
description: the conventional rehabilitation group completed hip joint range of motion and muscle strengthening exercises
arm group label: conventional rehabilitation + balance training group
arm group type: Experimental
description: The conventional rehabilitation + balance training group completed hip joint range of motion and muscle strengthening exercises and 12 balance exercises.
intervention type: Other
intervention name: Exercise training
arm group label: conventional rehabilitation + balance training group
arm group label: conventional rehabilitation group
other name: conventional rehabilitation
other name: conventional rehabilitation and balance training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Nuray Elibol, PhD
role: Principal Investigator
affiliation: Ege University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Nuray Elibol
investigator title: Assistant of Professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Hip
sharing ipd: No