<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/NCT03779724</url>
  </required_header>
  <id_info>
    <org_study_id>5070</org_study_id>
    <nct_id>NCT03779724</nct_id>
  </id_info>
  <brief_title>Isokinetic Exercises in Patients With Multiple Sclerosis</brief_title>
  <official_title>The Effects of Isokinetic Exercises on Muscle Strength, Joint Position Sense, and Kinesiophobia in Patients With Multiple Sclerosis: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aksaray University Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aksaray University Training and Research Hospital</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 investigators evaluated the effects of isokinetic muscle strengthening exercises of the&#xD;
      quadriceps and hamstring on muscle strength, joint position sense, pain, kinesiophobia and&#xD;
      quality of life in patients with multiple sclerosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To evaluate the effects of isokinetic exercises on muscle strength, knee joint&#xD;
      position sense, pain, kinesiophobia, and quality of life in patients with multiple sclerosis.&#xD;
&#xD;
      Design: Randomized controlled trial. Setting: Outpatient clinic. Participants: Fifty patients&#xD;
      with multiple sclerosis. Interventions: Fifty patients who met the inclusion criteria were&#xD;
      randomized to an isokinetic exercise (n:25) or home exercise programme (n:25). Sequentially&#xD;
      numbered opaque envelopes were used for randomization.&#xD;
&#xD;
      Outcome measures: The outcome measures were the peak torque/body mass index of quadriceps and&#xD;
      hamstring muscles at 60°/s and 180°/s velocities, the hamstring/quadriceps ratios at the same&#xD;
      velocities, absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular&#xD;
      error of joint position sense of the less and more affected knees, and the scores of Multiple&#xD;
      Sclerosis Quality of Life-54, Visual Analogue Scale, and Tampa Scale of Kinesiophobia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 29, 2015</start_date>
  <completion_date type="Actual">July 29, 2016</completion_date>
  <primary_completion_date type="Actual">July 29, 2016</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>
    <intervention_model_description>This prospective randomized controlled trial aimed to recruit 50 patients with MS from the physical medicine and rehabilitation clinic of Ankara Training and Research Hospital, Health Sciences University, Ankara, Turkey. Fifty patients who met the inclusion criteria were enrolled in the study. Fifty patients were randomized to two groups: isokinetic exercise (Group 1) (n=25) and home exercise (Group 2) (n=25). Randomization was completed using sequentially numbered, opaque envelopes by the investigator. All patients gave informed consent before the assessment. The outcome measures were assessed initially and at eighth week after the treatment. Group 1 performed isokinetic concentric quadriceps and hamstring strengthening exercises under supervision and Group 2 performed lower extremity muscle strengthening and balance exercises at home.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Isokinetic Muscle Strength Test of the More and Less Affected Knees</measure>
    <time_frame>At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment</time_frame>
    <description>The peak torque/body mass index of the quadriceps and hamstring muscles at 60°/s and 180°/s velocities were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) in Newton/meter. A definite muscle strength value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate better muscle strength.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Joint Position Sense of the More and Less Affected Knees</measure>
    <time_frame>At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment</time_frame>
    <description>Absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of the more and less affected knees were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) with active-active angular reproduction method. Estimating the target angel procedure was repeated at 45°, 15°, and 60° and for both the more and less affected legs. After the joint position sense testing, three angles estimated by the patients were averaged, and the angular error was calculated for each target angle. Absolute angular error was calculated by averaging the angular errors, regardless of the numbers being negative or positive. The absolute angular error values of the three target angles were averaged to obtain the mean absolute angular errors. A definite angular error value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate worser joint position sense.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tampa Scale of Kinesiophobia</measure>
    <time_frame>At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment</time_frame>
    <description>Kinesiophobia which is described as fear of movement and physical activity was evaluated using the Tampa Scale of Kinesiophobia, which is a 17-item self-report survey. The range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia. If the total score was above 37 points, the patient was considered to have a high level of kinesiophobia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score</measure>
    <time_frame>At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment</time_frame>
    <description>This is a multidimensional health-related quality of life measure that combines both generic and multiple sclerosis-specific symptoms in a single instrument. The 54 items are divided into 12 multi-item and 2 single-item scales.Health distress, overall quality of life, emotional well-being, role limitations-emotional and cognitive funtion items' final scores averaged and mental composite score was calculated. Physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, health distress items' final scores were averaged and physical composite score was obtained.Total score was obtained by averaging the mental and physical composite scores.Final scores can be between 0-100 points for total, mental, physical and pain scores. Higher values indicate better quality of life for total, physical and mental scores and worser pain levels for pain score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment</time_frame>
    <description>Pain intensity was evaluated with the Visual Analog Scale. Using a ruler, a 10 cm line was drawn which provided a range of scores from 0-100. Than the patients marked the point that showed their pain intensity on this line. A higher score in Visual Analog Scale indicates greater pain intensity.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>isokinetic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>home exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercises</intervention_name>
    <arm_group_label>home exercise</arm_group_label>
    <arm_group_label>isokinetic exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  definite relapsing remitting MS and secondary progressive MS diagnosis&#xD;
&#xD;
          -  mild and moderate MS determined by Kurtzke Expanded Disability Status Scale (EDSS)&#xD;
             scores below 6.5&#xD;
&#xD;
          -  a disease duration of more than one year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having an acute exacerbation within the last three months&#xD;
&#xD;
          -  intravenous pulse steroid therapy in the last four weeks&#xD;
&#xD;
          -  grade 3-4 spasticity according to the Modified Ashworth Scale&#xD;
&#xD;
          -  severe vision impairment&#xD;
&#xD;
          -  severe fatigue and depression&#xD;
&#xD;
          -  past knee surgery&#xD;
&#xD;
          -  other neurologic diseases&#xD;
&#xD;
          -  systemic diseases&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  having received an exercise program within the last four weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melek A Selçuk, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aksaray University Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aksaray University Training and Research Hospital</name>
      <address>
        <city>Aksaray</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Training and Researc Hospital, Health Sciences University</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Yahia A, Ghroubi S, Mhiri C, Elleuch MH. Relationship between muscular strength, gait and postural parameters in multiple sclerosis. Ann Phys Rehabil Med. 2011 May;54(3):144-55. doi: 10.1016/j.rehab.2011.02.004. Epub 2011 Mar 9. English, French.</citation>
    <PMID>21493176</PMID>
  </reference>
  <reference>
    <citation>Robineau S, Nicolas B, Gallien P, Petrilli S, Durufle A, Edan G, Rochcongar P. [Eccentric isokinetic strengthening in hamstrings of patients with multiple sclerosis]. Ann Readapt Med Phys. 2005 Feb;48(1):29-33. doi: 10.1016/j.annrmp.2004.04.005. French.</citation>
    <PMID>15664681</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <results_first_submitted>December 18, 2018</results_first_submitted>
  <results_first_submitted_qc>July 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 24, 2019</results_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aksaray University Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Melek Aykut Selçuk</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>multiple sclerosis</keyword>
  <keyword>isokinetic</keyword>
  <keyword>exercises</keyword>
  <keyword>joint position sense</keyword>
  <keyword>kinesiophobia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03779724/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This prospective randomized controlled trial aimed to recruit 50 patients with multiple sclerosis from the physical medicine and rehabilitation clinic of Ankara Training and Research Hospital, Health Sciences University, Ankara, Turkey.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Isokinetic Exercise</title>
          <description>The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.&#xD;
exercises</description>
        </group>
        <group group_id="P2">
          <title>Home Exercise</title>
          <description>The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.&#xD;
exercises</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Isokinetic Exercise</title>
          <description>The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.&#xD;
exercises</description>
        </group>
        <group group_id="B2">
          <title>Home Exercise</title>
          <description>The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.&#xD;
exercises</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.21" spread="8.81"/>
                    <measurement group_id="B2" value="39.95" spread="12.25"/>
                    <measurement group_id="B3" value="39.60" spread="10.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Isokinetic Muscle Strength Test of the More and Less Affected Knees</title>
        <description>The peak torque/body mass index of the quadriceps and hamstring muscles at 60°/s and 180°/s velocities were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) in Newton/meter. A definite muscle strength value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate better muscle strength.</description>
        <time_frame>At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Isokinetic Exercise Baseline</title>
            <description>The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.&#xD;
exercises</description>
          </group>
          <group group_id="O2">
            <title>Isokinetic Exercise After Treatment</title>
            <description>the outcome measurements of isokinetic exercises group after the treatment</description>
          </group>
          <group group_id="O3">
            <title>Home Exercise Baseline</title>
            <description>The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.&#xD;
exercises</description>
          </group>
          <group group_id="O4">
            <title>Home Exercise After Treatment</title>
            <description>the outcome measurements of home exercises group after the treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Isokinetic Muscle Strength Test of the More and Less Affected Knees</title>
          <description>The peak torque/body mass index of the quadriceps and hamstring muscles at 60°/s and 180°/s velocities were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) in Newton/meter. A definite muscle strength value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate better muscle strength.</description>
          <units>Newton/meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>60°/s Quadriceps PT/BMI(less affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.48" spread="37.20"/>
                    <measurement group_id="O2" value="141.05" spread="31.59"/>
                    <measurement group_id="O3" value="123.02" spread="53.80"/>
                    <measurement group_id="O4" value="127.83" spread="54.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60°/s Hamstring PT/BMI(less affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.25" spread="24.28"/>
                    <measurement group_id="O2" value="85.87" spread="21.00"/>
                    <measurement group_id="O3" value="72.85" spread="29.02"/>
                    <measurement group_id="O4" value="78.40" spread="31.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60°/s hamstring/quadriceps(less affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="0.14"/>
                    <measurement group_id="O2" value="0.61" spread="0.12"/>
                    <measurement group_id="O3" value="0.61" spread="0.14"/>
                    <measurement group_id="O4" value="0.62" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>180°/s Quadriceps PT/BMI(less affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.87" spread="24.51"/>
                    <measurement group_id="O2" value="82.87" spread="23.11"/>
                    <measurement group_id="O3" value="71.06" spread="32.01"/>
                    <measurement group_id="O4" value="76.54" spread="28.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>180°/s Hamstring PT/BMI(less affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.74" spread="17.76"/>
                    <measurement group_id="O2" value="56.85" spread="19.74"/>
                    <measurement group_id="O3" value="53.73" spread="22.55"/>
                    <measurement group_id="O4" value="56.76" spread="21.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>180°/s hamstring/quadriceps (less affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="0.19"/>
                    <measurement group_id="O2" value="0.69" spread="0.19"/>
                    <measurement group_id="O3" value="0.76" spread="0.22"/>
                    <measurement group_id="O4" value="0.74" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60°/s Quadriceps PT/BMI(more affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.46" spread="43.96"/>
                    <measurement group_id="O2" value="118.50" spread="45.52"/>
                    <measurement group_id="O3" value="100.16" spread="47.85"/>
                    <measurement group_id="O4" value="108.06" spread="48.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60°/s Hamstring PT/BMI(more affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.87" spread="33.60"/>
                    <measurement group_id="O2" value="77.70" spread="29.27"/>
                    <measurement group_id="O3" value="67.00" spread="30.87"/>
                    <measurement group_id="O4" value="72.80" spread="31.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60°/s Hamstring/Quadriceps(more affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77" spread="0.27"/>
                    <measurement group_id="O2" value="0.65" spread="0.12"/>
                    <measurement group_id="O3" value="0.71" spread="0.22"/>
                    <measurement group_id="O4" value="0.71" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>180°/s Quadriceps PT/BMI(more affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.42" spread="25.08"/>
                    <measurement group_id="O2" value="73.62" spread="23.53"/>
                    <measurement group_id="O3" value="57.18" spread="30.59"/>
                    <measurement group_id="O4" value="62.03" spread="29.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>180°/s Hamstring PT/BMI(more affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.25" spread="25.19"/>
                    <measurement group_id="O2" value="51.38" spread="23.24"/>
                    <measurement group_id="O3" value="46.19" spread="22.20"/>
                    <measurement group_id="O4" value="48.08" spread="23.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>180°/s Hamstring/Quadriceps(more affected knee)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" spread="0.58"/>
                    <measurement group_id="O2" value="0.66" spread="0.19"/>
                    <measurement group_id="O3" value="0.94" spread="0.58"/>
                    <measurement group_id="O4" value="0.85" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Joint Position Sense of the More and Less Affected Knees</title>
        <description>Absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of the more and less affected knees were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) with active-active angular reproduction method. Estimating the target angel procedure was repeated at 45°, 15°, and 60° and for both the more and less affected legs. After the joint position sense testing, three angles estimated by the patients were averaged, and the angular error was calculated for each target angle. Absolute angular error was calculated by averaging the angular errors, regardless of the numbers being negative or positive. The absolute angular error values of the three target angles were averaged to obtain the mean absolute angular errors. A definite angular error value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate worser joint position sense.</description>
        <time_frame>At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Isokinetic Exercise Baseline</title>
            <description>The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.&#xD;
exercises</description>
          </group>
          <group group_id="O2">
            <title>Isokinetic Exercise After Treatment</title>
            <description>the outcome measurements of isokinetic exercises group after the treatment</description>
          </group>
          <group group_id="O3">
            <title>Home Exercise Baseline</title>
            <description>The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.&#xD;
exercises</description>
          </group>
          <group group_id="O4">
            <title>Home Exercise After Treatment</title>
            <description>the outcome measurements of home exercises group after the treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Joint Position Sense of the More and Less Affected Knees</title>
          <description>Absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of the more and less affected knees were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) with active-active angular reproduction method. Estimating the target angel procedure was repeated at 45°, 15°, and 60° and for both the more and less affected legs. After the joint position sense testing, three angles estimated by the patients were averaged, and the angular error was calculated for each target angle. Absolute angular error was calculated by averaging the angular errors, regardless of the numbers being negative or positive. The absolute angular error values of the three target angles were averaged to obtain the mean absolute angular errors. A definite angular error value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate worser joint position sense.</description>
          <units>degree</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>mean absolute angular error of less affected knee</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.56" spread="2.78"/>
                    <measurement group_id="O2" value="4.39" spread="2.32"/>
                    <measurement group_id="O3" value="5.70" spread="3.19"/>
                    <measurement group_id="O4" value="5.03" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mean absolute angular error of lmore affected knee</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.94" spread="3.06"/>
                    <measurement group_id="O2" value="4.38" spread="1.94"/>
                    <measurement group_id="O3" value="5.76" spread="5.35"/>
                    <measurement group_id="O4" value="4.99" spread="3.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15° joint position sense of less affected knee</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.26" spread="4.70"/>
                    <measurement group_id="O2" value="3.87" spread="4.28"/>
                    <measurement group_id="O3" value="5.93" spread="5.26"/>
                    <measurement group_id="O4" value="5.32" spread="4.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15° joint position sense of more affected knee</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.61" spread="3.79"/>
                    <measurement group_id="O2" value="0.74" spread="4.04"/>
                    <measurement group_id="O3" value="4.96" spread="4.05"/>
                    <measurement group_id="O4" value="5.27" spread="3.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45° joint position sense of less affected knee</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.41" spread="3.61"/>
                    <measurement group_id="O2" value="5.86" spread="3.95"/>
                    <measurement group_id="O3" value="6.23" spread="4.36"/>
                    <measurement group_id="O4" value="4.94" spread="3.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45° joint position sense of more affected knee</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.73" spread="3.81"/>
                    <measurement group_id="O2" value="4.21" spread="2.95"/>
                    <measurement group_id="O3" value="5.80" spread="5.00"/>
                    <measurement group_id="O4" value="5.46" spread="4.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60° joint position sense of less affected knee</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.40" spread="3.08"/>
                    <measurement group_id="O2" value="3.39" spread="3.00"/>
                    <measurement group_id="O3" value="4.55" spread="4.78"/>
                    <measurement group_id="O4" value="3.76" spread="4.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60° joint position sense of more affected knee</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.02" spread="4.99"/>
                    <measurement group_id="O2" value="4.17" spread="2.52"/>
                    <measurement group_id="O3" value="4.18" spread="6.67"/>
                    <measurement group_id="O4" value="3.47" spread="3.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tampa Scale of Kinesiophobia</title>
        <description>Kinesiophobia which is described as fear of movement and physical activity was evaluated using the Tampa Scale of Kinesiophobia, which is a 17-item self-report survey. The range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia. If the total score was above 37 points, the patient was considered to have a high level of kinesiophobia.</description>
        <time_frame>At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Isokinetic Exercise Baseline</title>
            <description>The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.&#xD;
exercises</description>
          </group>
          <group group_id="O2">
            <title>Isokinetic Exercise After Treatment</title>
            <description>the outcome measurements of isokinetic exercises group after the treatment</description>
          </group>
          <group group_id="O3">
            <title>Home Exercise Baseline</title>
            <description>The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.&#xD;
exercises</description>
          </group>
          <group group_id="O4">
            <title>Home Exercise After Treatment</title>
            <description>the outcome measurements of home exercises group after the treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Tampa Scale of Kinesiophobia</title>
          <description>Kinesiophobia which is described as fear of movement and physical activity was evaluated using the Tampa Scale of Kinesiophobia, which is a 17-item self-report survey. The range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia. If the total score was above 37 points, the patient was considered to have a high level of kinesiophobia.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.42" spread="5.48"/>
                    <measurement group_id="O2" value="40.57" spread="7.25"/>
                    <measurement group_id="O3" value="40.33" spread="6.37"/>
                    <measurement group_id="O4" value="40.33" spread="7.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score</title>
        <description>This is a multidimensional health-related quality of life measure that combines both generic and multiple sclerosis-specific symptoms in a single instrument. The 54 items are divided into 12 multi-item and 2 single-item scales.Health distress, overall quality of life, emotional well-being, role limitations-emotional and cognitive funtion items' final scores averaged and mental composite score was calculated. Physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, health distress items' final scores were averaged and physical composite score was obtained.Total score was obtained by averaging the mental and physical composite scores.Final scores can be between 0-100 points for total, mental, physical and pain scores. Higher values indicate better quality of life for total, physical and mental scores and worser pain levels for pain score.</description>
        <time_frame>At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Isokinetic Exercise Baseline</title>
            <description>The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.&#xD;
exercises</description>
          </group>
          <group group_id="O2">
            <title>Isokinetic Exercise After Treatment</title>
            <description>the outcome measurements of isokinetic exercises group after the treatment</description>
          </group>
          <group group_id="O3">
            <title>Home Exercise Baseline</title>
            <description>The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.&#xD;
exercises</description>
          </group>
          <group group_id="O4">
            <title>Home Exercise After Treatment</title>
            <description>the outcome measurements of home exercises group after the treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score</title>
          <description>This is a multidimensional health-related quality of life measure that combines both generic and multiple sclerosis-specific symptoms in a single instrument. The 54 items are divided into 12 multi-item and 2 single-item scales.Health distress, overall quality of life, emotional well-being, role limitations-emotional and cognitive funtion items' final scores averaged and mental composite score was calculated. Physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, health distress items' final scores were averaged and physical composite score was obtained.Total score was obtained by averaging the mental and physical composite scores.Final scores can be between 0-100 points for total, mental, physical and pain scores. Higher values indicate better quality of life for total, physical and mental scores and worser pain levels for pain score.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MSQoL-54 (total)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.20" spread="17.98"/>
                    <measurement group_id="O2" value="57.00" spread="18.95"/>
                    <measurement group_id="O3" value="61.38" spread="18.54"/>
                    <measurement group_id="O4" value="59.39" spread="20.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MSQoL-54 (physical)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.79" spread="17.02"/>
                    <measurement group_id="O2" value="54.69" spread="18.31"/>
                    <measurement group_id="O3" value="58.64" spread="19.81"/>
                    <measurement group_id="O4" value="56.69" spread="22.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MSQoL-54 (mental)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.59" spread="20.71"/>
                    <measurement group_id="O2" value="59.33" spread="21.81"/>
                    <measurement group_id="O3" value="64.11" spread="20.41"/>
                    <measurement group_id="O4" value="62.07" spread="22.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MSQoL-54 (pain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.52" spread="26.90"/>
                    <measurement group_id="O2" value="58.57" spread="30.10"/>
                    <measurement group_id="O3" value="71.74" spread="28.52"/>
                    <measurement group_id="O4" value="67.83" spread="29.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale</title>
        <description>Pain intensity was evaluated with the Visual Analog Scale. Using a ruler, a 10 cm line was drawn which provided a range of scores from 0-100. Than the patients marked the point that showed their pain intensity on this line. A higher score in Visual Analog Scale indicates greater pain intensity.</description>
        <time_frame>At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Isokinetic Exercise Baseline</title>
            <description>The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.&#xD;
exercises</description>
          </group>
          <group group_id="O2">
            <title>Isokinetic Exercise After Treatment</title>
            <description>the outcome measurements of isokinetic exercises group after the treatment</description>
          </group>
          <group group_id="O3">
            <title>Home Exercise Baseline</title>
            <description>The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.&#xD;
exercises</description>
          </group>
          <group group_id="O4">
            <title>Home Exercise After Treatment</title>
            <description>the outcome measurements of home exercises group after the treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale</title>
          <description>Pain intensity was evaluated with the Visual Analog Scale. Using a ruler, a 10 cm line was drawn which provided a range of scores from 0-100. Than the patients marked the point that showed their pain intensity on this line. A higher score in Visual Analog Scale indicates greater pain intensity.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.78" spread="34.16"/>
                    <measurement group_id="O2" value="36.68" spread="36.66"/>
                    <measurement group_id="O3" value="41.66" spread="31.11"/>
                    <measurement group_id="O4" value="42.14" spread="29.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>adverse events were not monitored/assessed.</time_frame>
      <desc>adverse events were not monitored/assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Isokinetic Exercise</title>
          <description>The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.&#xD;
exercises</description>
        </group>
        <group group_id="E2">
          <title>Home Exercise</title>
          <description>The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.&#xD;
exercises</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The limitations of the study include the low number of patients, lower EDSS scores, lack of a long-term evaluation of isokinetic exercises, and absence of a healthy control group.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>The principal investigator</name_or_title>
      <organization>Aksaray University Training and Research Hospital</organization>
      <phone>905555289493</phone>
      <email>mlk.aykut@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03779724
org study id: 5070
nct id: NCT03779724
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators evaluated the effects of isokinetic muscle strengthening exercises of the
      quadriceps and hamstring on muscle strength, joint position sense, pain, kinesiophobia and
      quality of life in patients with multiple sclerosis.
Objective: To evaluate the effects of isokinetic exercises on muscle strength, knee joint
      position sense, pain, kinesiophobia, and quality of life in patients with multiple sclerosis.

      Design: Randomized controlled trial. Setting: Outpatient clinic. Participants: Fifty patients
      with multiple sclerosis. Interventions: Fifty patients who met the inclusion criteria were
      randomized to an isokinetic exercise (n:25) or home exercise programme (n:25). Sequentially
      numbered opaque envelopes were used for randomization.

      Outcome measures: The outcome measures were the peak torque/body mass index of quadriceps and
      hamstring muscles at 60°/s and 180°/s velocities, the hamstring/quadriceps ratios at the same
      velocities, absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular
      error of joint position sense of the less and more affected knees, and the scores of Multiple
      Sclerosis Quality of Life-54, Visual Analogue Scale, and Tampa Scale of Kinesiophobia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This prospective randomized controlled trial aimed to recruit 50 patients with MS from the physical medicine and rehabilitation clinic of Ankara Training and Research Hospital, Health Sciences University, Ankara, Turkey. Fifty patients who met the inclusion criteria were enrolled in the study. Fifty patients were randomized to two groups: isokinetic exercise (Group 1) (n=25) and home exercise (Group 2) (n=25). Randomization was completed using sequentially numbered, opaque envelopes by the investigator. All patients gave informed consent before the assessment. The outcome measures were assessed initially and at eighth week after the treatment. Group 1 performed isokinetic concentric quadriceps and hamstring strengthening exercises under supervision and Group 2 performed lower extremity muscle strengthening and balance exercises at home.
primary purpose: Treatment
masking: None (Open Label)
measure: Isokinetic Muscle Strength Test of the More and Less Affected Knees
time frame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
description: The peak torque/body mass index of the quadriceps and hamstring muscles at 60°/s and 180°/s velocities were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) in Newton/meter. A definite muscle strength value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate better muscle strength.
measure: Joint Position Sense of the More and Less Affected Knees
time frame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
description: Absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of the more and less affected knees were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) with active-active angular reproduction method. Estimating the target angel procedure was repeated at 45°, 15°, and 60° and for both the more and less affected legs. After the joint position sense testing, three angles estimated by the patients were averaged, and the angular error was calculated for each target angle. Absolute angular error was calculated by averaging the angular errors, regardless of the numbers being negative or positive. The absolute angular error values of the three target angles were averaged to obtain the mean absolute angular errors. A definite angular error value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate worser joint position sense.
measure: Tampa Scale of Kinesiophobia
time frame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
description: Kinesiophobia which is described as fear of movement and physical activity was evaluated using the Tampa Scale of Kinesiophobia, which is a 17-item self-report survey. The range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia. If the total score was above 37 points, the patient was considered to have a high level of kinesiophobia.
measure: Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score
time frame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
description: This is a multidimensional health-related quality of life measure that combines both generic and multiple sclerosis-specific symptoms in a single instrument. The 54 items are divided into 12 multi-item and 2 single-item scales.Health distress, overall quality of life, emotional well-being, role limitations-emotional and cognitive funtion items' final scores averaged and mental composite score was calculated. Physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, health distress items' final scores were averaged and physical composite score was obtained.Total score was obtained by averaging the mental and physical composite scores.Final scores can be between 0-100 points for total, mental, physical and pain scores. Higher values indicate better quality of life for total, physical and mental scores and worser pain levels for pain score.
measure: Visual Analog Scale
time frame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
description: Pain intensity was evaluated with the Visual Analog Scale. Using a ruler, a 10 cm line was drawn which provided a range of scores from 0-100. Than the patients marked the point that showed their pain intensity on this line. A higher score in Visual Analog Scale indicates greater pain intensity.
arm group label: isokinetic exercise
arm group type: Experimental
description: The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.
arm group label: home exercise
arm group type: Active Comparator
description: The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.
intervention type: Other
intervention name: exercises
arm group label: home exercise
arm group label: isokinetic exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Melek A Selçuk, MD
role: Principal Investigator
affiliation: Aksaray University Training and Research Hospital
facility: 
facility: 
country: Turkey
citation: Yahia A, Ghroubi S, Mhiri C, Elleuch MH. Relationship between muscular strength, gait and postural parameters in multiple sclerosis. Ann Phys Rehabil Med. 2011 May;54(3):144-55. doi: 10.1016/j.rehab.2011.02.004. Epub 2011 Mar 9. English, French.
PMID: 21493176
citation: Robineau S, Nicolas B, Gallien P, Petrilli S, Durufle A, Edan G, Rochcongar P. [Eccentric isokinetic strengthening in hamstrings of patients with multiple sclerosis]. Ann Readapt Med Phys. 2005 Feb;48(1):29-33. doi: 10.1016/j.annrmp.2004.04.005. French.
PMID: 15664681
responsible party type: Principal Investigator
investigator affiliation: Aksaray University Training and Research Hospital
investigator full name: Dr. Melek Aykut Selçuk
investigator title: Principal Investigator
mesh term: Multiple Sclerosis
mesh term: Sclerosis
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The limitations of the study include the low number of patients, lower EDSS scores, lack of a long-term evaluation of isokinetic exercises, and absence of a healthy control group.
point of contact: 