xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05991297</url>
    </required_header>
    <id_info>
      <org_study_id>ROMATEM-NERMİN ÇALIŞIR 2023</org_study_id>
      <nct_id>NCT05991297</nct_id>
    </id_info>
    <brief_title>Effects of Deep Sensory Assisted Rehabilitation on Gait and Balance in Patients With Multiple Sclerosis</brief_title>
    <official_title>Effects of Deep Sensory Assisted Rehabilitation on Gait and Balance in Patients With Multiple Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nermin Çalışır</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bursa Sevket Yilmaz Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Romatem Bursa 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 effect of physical therapy and rehabilitation on improving the gait and balance disorders&#xD;
        of patients has been proven. FTR applications in MS patients have become routine in developed&#xD;
        countries. However, due to the high patient density in our country, FTR cannot be performed&#xD;
        at the rate we want due to different reasons such as the inability to separate areas special&#xD;
        for MS patients, the lack of special FTR applications for MS patients, and the inability to&#xD;
        perform regular FTR follow-ups. Even if FTR is recommended and performed, our patients think&#xD;
        that FTR is not very effective due to the above reasons and they do not continue.&#xD;
  &#xD;
        A team of neurology, physical therapy specialists, and physiotherapists was formed,&#xD;
        in-service training was completed and a special rehabilitation program for MS patients was&#xD;
        created. First of all, we will apply routine classical FTR to our patients. Sensory and deep&#xD;
        sensory disorders, which are more common and severe, especially in the lower extremities,&#xD;
        also negatively affect gait and balance.&#xD;
  &#xD;
        A rehabilitation program was created by adding exercises to improve sensation and deep sense,&#xD;
        along with muscle strengthening. The results of the 1st and 21st sessions of the patients in&#xD;
        the two groups who underwent classical rehabilitation and deep sensory-assisted&#xD;
        rehabilitation will be compared. It was planned to evaluate the gait and balance parameters&#xD;
        of the patients as numerical data with clinical scales and the C mill device we used in&#xD;
        walking and balance exercises.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Muscle strengthening in all four extremities; strengthening of trunk and abdominal muscles;&#xD;
        providing and maintaining joint range of motion; independent and safe standing, turning, and&#xD;
        stepping; able to walk alone on flat ground and on different surfaces (such as&#xD;
        sloping-handicapped-soil-stone-sand-grass-rough-stepped); increase in exercise capacity,&#xD;
        duration, distance; An increase in the number of steps per minute and step length is&#xD;
        expected.&#xD;
  &#xD;
        It was thought that both classical rehabilitation and deep sensory-assisted rehabilitation&#xD;
        would improve gait and balance parameters.&#xD;
  &#xD;
        There has been previous research showing the effects of FTR. What we will do in addition and&#xD;
        new with this research;&#xD;
  &#xD;
          -  The effects of classical rehabilitation and deep sensory-assisted rehabilitation will be&#xD;
             compared&#xD;
  &#xD;
          -  A new PTR plan called &quot;deep sensory assisted rehabilitation&quot; was created: it was aimed&#xD;
             to develop a sensory and deep sense in the adult age group by making use of sensory&#xD;
             integration exercises, which are mostly applied in the childhood age group. Whether&#xD;
             these exercises are effective on walking and balance will be evaluated. Patients will be&#xD;
             dressed in a vest with an equally distributed weight of 4-6 kg according to their&#xD;
             weight, and exercises will be done while walking and standing.&#xD;
  &#xD;
          -  the so-called &quot;deep sensory pathway&quot;; The patients will be given standing and walking&#xD;
             exercises on sand and stone floors, soft floors made of sponge, hard plastic floors with&#xD;
             different sizes of grooves and shapes, and hot-cold floors formed by placing hot packs&#xD;
             and cold packs.&#xD;
  &#xD;
          -  Most of the previous studies have shown the effect of FTR using clinical scales. In&#xD;
             developed countries, gait analysis was performed. In our research, we aimed to measure&#xD;
             gait and balance parameters in C-mill walking and balance exercise devices, together&#xD;
             with clinical scales, as numerical data and graphics. The patient's standing and walking&#xD;
             on the treadmill, stride length, stride symmetry, walking speed, distance, duration,&#xD;
             cadence, and percentage deviation from targets during tandem and slalom walking&#xD;
             parameters will be recorded as objective numerical data and graphics. These measurements&#xD;
             will be recorded in the 1st session and the 21st session.&#xD;
  &#xD;
        Changes in patients will be seen with clinical scales and visual evaluations. However, in&#xD;
        order to make the evaluation more objective for both the patient and the practitioner, these&#xD;
        measurements made with the C mill will also be made.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>classic rehabilitation group vs.deep sensory assisted rehabilitation group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Multipl sclerosis quality of life-54(MSQOL-54)</measure>
      <time_frame>1st day: when rehabilitation applications started</time_frame>
      <description>: It is calculated with the combined summary scores of physical and mental health. As the total score increases, the quality of life is evaluated positively.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Multipl sclerosis quality of life-54(MSQOL-54)</measure>
      <time_frame>after 7 weeks: when rehabilitation applications ended</time_frame>
      <description>: It is calculated with the combined summary scores of physical and mental health. As the total score increases, the quality of life is evaluated positively. The scale has not minimum and maximum value. The change between the participant's prior and values was evaluated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MiniBest test</measure>
      <time_frame>1st day: when rehabilitation applications started</time_frame>
      <description>minimum and maximum score: 0-28: high score indicates good functional balance</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MiniBest test</measure>
      <time_frame>after 7 weeks: when rehabilitation applications ended</time_frame>
      <description>minimum and maximum score: 0-28: high score indicates good functional balance</description>
    </primary_outcome>
    <primary_outcome>
      <measure>10 meter walking time</measure>
      <time_frame>1st day: when rehabilitation applications started</time_frame>
      <description>The patient's walking time of the determined 10-meter distance is measured.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>10 meter walking time</measure>
      <time_frame>after 7 weeks: when rehabilitation applications ended</time_frame>
      <description>The patient's walking time of the determined 10-meter distance is measured.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Nottingham Extended Activities of Daily Living Scale</measure>
      <time_frame>1st day: when rehabilitation applications started</time_frame>
      <description>minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Nottingham Extended Activities of Daily Living Scale</measure>
      <time_frame>after 7 weeks: when rehabilitation applications ended</time_frame>
      <description>minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Ambulation Classification</measure>
      <time_frame>1st day: when rehabilitation applications started</time_frame>
      <description>minimum and maximum score :0-5: high score indicates that walking can be done independently.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Ambulation Classification</measure>
      <time_frame>after 7 weeks: when rehabilitation applications ended</time_frame>
      <description>minimum and maximum score :0-5: high score indicates that walking can be done independently.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue Severity Score</measure>
      <time_frame>1st day: when rehabilitation applications started</time_frame>
      <description>A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue Severity Score</measure>
      <time_frame>after 7 weeks: when rehabilitation applications ended</time_frame>
      <description>A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue</description>
    </primary_outcome>
    <primary_outcome>
      <measure>DN4(Douleur Neuropathique 4 Questions)</measure>
      <time_frame>1st day: when rehabilitation applications started</time_frame>
      <description>Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>DN4(Douleur Neuropathique 4 Questions)</measure>
      <time_frame>after 7 weeks: when rehabilitation applications ended</time_frame>
      <description>Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MSWS-12( MS walking scale-12)</measure>
      <time_frame>1st day: when rehabilitation applications started</time_frame>
      <description>minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MSWS-12( MS walking scale-12)</measure>
      <time_frame>after 7 weeks: when rehabilitation applications ended</time_frame>
      <description>minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>FES-1: (Falls Efficay Scale-1)</measure>
      <time_frame>1st day: when rehabilitation applications started</time_frame>
      <description>minimum and maximum score: 16-64: higher score indicates increased anxiety about falling</description>
    </primary_outcome>
    <primary_outcome>
      <measure>FES-1: (Falls Efficay Scale-1)</measure>
      <time_frame>after 7 weeks: when rehabilitation applications ended</time_frame>
      <description>minimum and maximum score: 16-64: higher score indicates increased anxiety about falling</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>MS (Multiple Sclerosis)</condition>
    <arm_group>
      <arm_group_label>Classical physical therapy and rehabilitation program</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Classical rehabilitation program (stretching, strenght, balance and coordination exercise) for fifty minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Deep sensory asisted therapy and rehabilitation program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Deep sensory asisted rehabilitation program (stretching, strenght, balance and coordination and deep sensory exercises) for fifty minutes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Deep sensory assisted rehabilitation</intervention_name>
      <description>A new PTR plan called &quot;deep sensory assisted rehabilitation&quot; was created: it was aimed to develop a sensory and deep sense in the adult age group by making use of sensory integration exercises, which are mostly applied in the childhood age group. Whether these exercises are effective on walking and balance will be evaluated. Patients will be dressed in a vest with an equally distributed weight of 4-6 kg according to their weight, and exercises will be done while walking and standing.&#xD;
  - the so-called &quot;deep sensory pathway&quot;; The patients will be given standing and walking exercises on sand and stone floors, soft floors made of sponge, hard plastic floors with different sizes of grooves and shapes, and hot-cold floors formed by placing hot packs and cold packs.</description>
      <arm_group_label>Deep sensory asisted therapy and rehabilitation program</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>classical rehabilitation</intervention_name>
      <description>Muscle strengthening in all four extremities; strengthening of trunk and abdominal muscles; providing and maintaining joint range of motion; independent and safe standing, turning, and stepping; able to walk alone on flat ground and on different surfaces (such as sloping-handicapped-soil-stone-sand-grass-rough-stepped)</description>
      <arm_group_label>Classical physical therapy and rehabilitation program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with multiple sclerosis&#xD;
  &#xD;
            -  20-60 years old&#xD;
  &#xD;
            -  EDSS between 3.0-5.5 Those with EDSS 0-2.5 and spinal and/or cerebellar involvement&#xD;
  &#xD;
            -  Had the last MS attack at least 3 months ago&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  schizoaffective disorder&#xD;
  &#xD;
            -  lower extremity amputation&#xD;
  &#xD;
            -  shortness on one side creating asymmetry in the lower extremities&#xD;
  &#xD;
            -  diabetes mellitus&#xD;
  &#xD;
            -  cognitive impairment (at a level that may interfere with communication)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>NERMİN ÇALIŞIR</last_name>
      <role>Study Chair</role>
      <affiliation>ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>NURTEN KÜÇÜKÇAKIR</last_name>
      <role>Study Director</role>
      <affiliation>ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>MERAL SEFEROĞLU</last_name>
      <role>Study Director</role>
      <affiliation>UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>ALİ ÖZHAN SIVACI</last_name>
      <role>Principal Investigator</role>
      <affiliation>UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>CELAL BATUHAN GÜNEYSU</last_name>
      <role>Principal Investigator</role>
      <affiliation>ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>İSMAİL HACIOĞLU</last_name>
      <role>Principal Investigator</role>
      <affiliation>ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>YUSUF ZİYA ŞAHİN</last_name>
      <role>Principal Investigator</role>
      <affiliation>ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>MUHAMMED SOC HASANOĞLU</last_name>
      <role>Principal Investigator</role>
      <affiliation>ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>MAHMUT CAN ERDOĞAN</last_name>
      <role>Principal Investigator</role>
      <affiliation>ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL</affiliation>
    </overall_official>
    <overall_official>
      <last_name>SİNAN ATİLLA</last_name>
      <role>Principal Investigator</role>
      <affiliation>ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital</name>
        <address>
          <city>Bursa</city>
          <state>Yildirim</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospital</name>
        <address>
          <city>Bursa</city>
          <zip>16030</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Romatem Bursa Hospital</investigator_affiliation>
      <investigator_full_name>Nermin Çalışır</investigator_full_name>
      <investigator_title>Principal İnvestigator,Head of Neurology</investigator_title>
    </responsible_party>
    <keyword>deep sensory assisted rehabilitation</keyword>
    <keyword>MS gait and balance</keyword>
    <keyword>deep sensory walkway</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05991297
  org study id: ROMATEM-NERMİN ÇALIŞIR 2023
  nct id: NCT05991297
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The effect of physical therapy and rehabilitation on improving the gait and balance disorders
        of patients has been proven. FTR applications in MS patients have become routine in developed
        countries. However, due to the high patient density in our country, FTR cannot be performed
        at the rate we want due to different reasons such as the inability to separate areas special
        for MS patients, the lack of special FTR applications for MS patients, and the inability to
        perform regular FTR follow-ups. Even if FTR is recommended and performed, our patients think
        that FTR is not very effective due to the above reasons and they do not continue.
  
        A team of neurology, physical therapy specialists, and physiotherapists was formed,
        in-service training was completed and a special rehabilitation program for MS patients was
        created. First of all, we will apply routine classical FTR to our patients. Sensory and deep
        sensory disorders, which are more common and severe, especially in the lower extremities,
        also negatively affect gait and balance.
  
        A rehabilitation program was created by adding exercises to improve sensation and deep sense,
        along with muscle strengthening. The results of the 1st and 21st sessions of the patients in
        the two groups who underwent classical rehabilitation and deep sensory-assisted
        rehabilitation will be compared. It was planned to evaluate the gait and balance parameters
        of the patients as numerical data with clinical scales and the C mill device we used in
        walking and balance exercises.
  Muscle strengthening in all four extremities; strengthening of trunk and abdominal muscles;
        providing and maintaining joint range of motion; independent and safe standing, turning, and
        stepping; able to walk alone on flat ground and on different surfaces (such as
        sloping-handicapped-soil-stone-sand-grass-rough-stepped); increase in exercise capacity,
        duration, distance; An increase in the number of steps per minute and step length is
        expected.
  
        It was thought that both classical rehabilitation and deep sensory-assisted rehabilitation
        would improve gait and balance parameters.
  
        There has been previous research showing the effects of FTR. What we will do in addition and
        new with this research;
  
          -  The effects of classical rehabilitation and deep sensory-assisted rehabilitation will be
             compared
  
          -  A new PTR plan called "deep sensory assisted rehabilitation" was created: it was aimed
             to develop a sensory and deep sense in the adult age group by making use of sensory
             integration exercises, which are mostly applied in the childhood age group. Whether
             these exercises are effective on walking and balance will be evaluated. Patients will be
             dressed in a vest with an equally distributed weight of 4-6 kg according to their
             weight, and exercises will be done while walking and standing.
  
          -  the so-called "deep sensory pathway"; The patients will be given standing and walking
             exercises on sand and stone floors, soft floors made of sponge, hard plastic floors with
             different sizes of grooves and shapes, and hot-cold floors formed by placing hot packs
             and cold packs.
  
          -  Most of the previous studies have shown the effect of FTR using clinical scales. In
             developed countries, gait analysis was performed. In our research, we aimed to measure
             gait and balance parameters in C-mill walking and balance exercise devices, together
             with clinical scales, as numerical data and graphics. The patient's standing and walking
             on the treadmill, stride length, stride symmetry, walking speed, distance, duration,
             cadence, and percentage deviation from targets during tandem and slalom walking
             parameters will be recorded as objective numerical data and graphics. These measurements
             will be recorded in the 1st session and the 21st session.
  
        Changes in patients will be seen with clinical scales and visual evaluations. However, in
        order to make the evaluation more objective for both the patient and the practitioner, these
        measurements made with the C mill will also be made.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: classic rehabilitation group vs.deep sensory assisted rehabilitation group
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Multipl sclerosis quality of life-54(MSQOL-54)
  time frame: 1st day: when rehabilitation applications started
  description: : It is calculated with the combined summary scores of physical and mental health. As the total score increases, the quality of life is evaluated positively.
  measure: Multipl sclerosis quality of life-54(MSQOL-54)
  time frame: after 7 weeks: when rehabilitation applications ended
  description: : It is calculated with the combined summary scores of physical and mental health. As the total score increases, the quality of life is evaluated positively. The scale has not minimum and maximum value. The change between the participant's prior and values was evaluated.
  measure: MiniBest test
  time frame: 1st day: when rehabilitation applications started
  description: minimum and maximum score: 0-28: high score indicates good functional balance
  measure: MiniBest test
  time frame: after 7 weeks: when rehabilitation applications ended
  description: minimum and maximum score: 0-28: high score indicates good functional balance
  measure: 10 meter walking time
  time frame: 1st day: when rehabilitation applications started
  description: The patient's walking time of the determined 10-meter distance is measured.
  measure: 10 meter walking time
  time frame: after 7 weeks: when rehabilitation applications ended
  description: The patient's walking time of the determined 10-meter distance is measured.
  measure: Nottingham Extended Activities of Daily Living Scale
  time frame: 1st day: when rehabilitation applications started
  description: minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.
  measure: Nottingham Extended Activities of Daily Living Scale
  time frame: after 7 weeks: when rehabilitation applications ended
  description: minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.
  measure: Functional Ambulation Classification
  time frame: 1st day: when rehabilitation applications started
  description: minimum and maximum score :0-5: high score indicates that walking can be done independently.
  measure: Functional Ambulation Classification
  time frame: after 7 weeks: when rehabilitation applications ended
  description: minimum and maximum score :0-5: high score indicates that walking can be done independently.
  measure: Fatigue Severity Score
  time frame: 1st day: when rehabilitation applications started
  description: A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue
  measure: Fatigue Severity Score
  time frame: after 7 weeks: when rehabilitation applications ended
  description: A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue
  measure: DN4(Douleur Neuropathique 4 Questions)
  time frame: 1st day: when rehabilitation applications started
  description: Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.
  measure: DN4(Douleur Neuropathique 4 Questions)
  time frame: after 7 weeks: when rehabilitation applications ended
  description: Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.
  measure: MSWS-12( MS walking scale-12)
  time frame: 1st day: when rehabilitation applications started
  description: minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.
  measure: MSWS-12( MS walking scale-12)
  time frame: after 7 weeks: when rehabilitation applications ended
  description: minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.
  measure: FES-1: (Falls Efficay Scale-1)
  time frame: 1st day: when rehabilitation applications started
  description: minimum and maximum score: 16-64: higher score indicates increased anxiety about falling
  measure: FES-1: (Falls Efficay Scale-1)
  time frame: after 7 weeks: when rehabilitation applications ended
  description: minimum and maximum score: 16-64: higher score indicates increased anxiety about falling
  arm group label: Classical physical therapy and rehabilitation program
  arm group type: Active Comparator
  description: Classical rehabilitation program (stretching, strenght, balance and coordination exercise) for fifty minutes.
  arm group label: Deep sensory asisted therapy and rehabilitation program
  arm group type: Experimental
  description: Deep sensory asisted rehabilitation program (stretching, strenght, balance and coordination and deep sensory exercises) for fifty minutes.
  intervention type: Other
  intervention name: Deep sensory assisted rehabilitation
  description: A new PTR plan called "deep sensory assisted rehabilitation" was created: it was aimed to develop a sensory and deep sense in the adult age group by making use of sensory integration exercises, which are mostly applied in the childhood age group. Whether these exercises are effective on walking and balance will be evaluated. Patients will be dressed in a vest with an equally distributed weight of 4-6 kg according to their weight, and exercises will be done while walking and standing.
  - the so-called "deep sensory pathway"; The patients will be given standing and walking exercises on sand and stone floors, soft floors made of sponge, hard plastic floors with different sizes of grooves and shapes, and hot-cold floors formed by placing hot packs and cold packs.
  arm group label: Deep sensory asisted therapy and rehabilitation program
  intervention type: Other
  intervention name: classical rehabilitation
  description: Muscle strengthening in all four extremities; strengthening of trunk and abdominal muscles; providing and maintaining joint range of motion; independent and safe standing, turning, and stepping; able to walk alone on flat ground and on different surfaces (such as sloping-handicapped-soil-stone-sand-grass-rough-stepped)
  arm group label: Classical physical therapy and rehabilitation program
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: NERMİN ÇALIŞIR
  role: Study Chair
  affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
  last name: NURTEN KÜÇÜKÇAKIR
  role: Study Director
  affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
  last name: MERAL SEFEROĞLU
  role: Study Director
  affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
  last name: ALİ ÖZHAN SIVACI
  role: Principal Investigator
  affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
  last name: CELAL BATUHAN GÜNEYSU
  role: Principal Investigator
  affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
  last name: İSMAİL HACIOĞLU
  role: Principal Investigator
  affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
  last name: YUSUF ZİYA ŞAHİN
  role: Principal Investigator
  affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
  last name: MUHAMMED SOC HASANOĞLU
  role: Principal Investigator
  affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
  last name: MAHMUT CAN ERDOĞAN
  role: Principal Investigator
  affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
  last name: SİNAN ATİLLA
  role: Principal Investigator
  affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
  facility: 
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Romatem Bursa Hospital
  investigator full name: Nermin Çalışır
  investigator title: Principal İnvestigator,Head of Neurology
  mesh term: Multiple Sclerosis
  mesh term: Sclerosis