<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/NCT04403152</url>
  </required_header>
  <id_info>
    <org_study_id>2017/53</org_study_id>
    <nct_id>NCT04403152</nct_id>
  </id_info>
  <brief_title>Postoperative Rehabilitation or Mobilization After Scoliosis Surgery</brief_title>
  <official_title>Five Days of Intensive Postoperative Rehabilitation is Superior Than Mobilization in Improving Length of Hospitalization and Outcome of Patients Having Scoliosis Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Scoliosis surgery is a major surgery associated with postoperative pain, loss of physical&#xD;
      function and pulmonary dysfunction in adolescent idiopathic scoliosis patients (AIS).Despite&#xD;
      the advanced, various medical treatment methods of pain applied in the postoperative period,&#xD;
      the mean period of hospitalization is 5 to 7 days. The increasing health expenditures over&#xD;
      the years have brought along the need for rehabilitation programs conducted in the early&#xD;
      term. Although early mobilization has been accepted as a rule of thumb by spinal surgeons in&#xD;
      preventing the performance loss and reducing the causes of morbidity in recent years, the&#xD;
      investigators could not find any research on postoperative rehabilitation implemented on&#xD;
      patients under the supervision of a physiotherapist, following scoliosis surgery. The aim of&#xD;
      this study was to compare effect of five days of intensive postoperative rehabilitation and&#xD;
      mobilization on length of hospitalization and outcome in patients having scoliosis surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following spinal surgeries, patients experienced deep somatic pain and severe reflex spasms&#xD;
      of the muscles located in the surgical site. In addition, pulmonary dysfunction could develop&#xD;
      due to reduced flexibility of the spine and mobility of the ribs. It is a known fact that&#xD;
      cardiopulmonary functions in adolescent idiopathic scoliosis patients may not recover even&#xD;
      two years after surgery. After fusion surgeries in patients with scoliosis have shown that&#xD;
      the static and dynamic postural control were impaired and that the postural control could&#xD;
      recover one year after the surgery. The increasing health expenditures over the years have&#xD;
      brought along the need for rehabilitation programs conducted in the early term.&#xD;
&#xD;
      Increased postoperative pain, impaired balance reactions in the short, weak EMG responses of&#xD;
      the trunk muscles, decreased pulmonary capacity and increased health costs have necessitated&#xD;
      early rehabilitation in patients who had undergone scoliosis surgery. Also, the need for&#xD;
      further research on the effects of physiotherapeutic approaches on the aforementioned&#xD;
      functional losses has been indicated in several studies.Although early mobilization has been&#xD;
      accepted as a rule of thumb by spinal surgeons in preventing the performance loss and&#xD;
      reducing the causes of morbidity in recent years, the investigators could not find any&#xD;
      research on postoperative rehabilitation implemented on patients under the supervision of a&#xD;
      physiotherapist, following scoliosis surgery.&#xD;
&#xD;
      Therefore, based on these findings, the aim of this study was to compare effect of five days&#xD;
      of intensive postoperative rehabilitation and mobilization on length of hospitalization and&#xD;
      outcome in patients having scoliosis surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2017</start_date>
  <completion_date type="Actual">November 15, 2017</completion_date>
  <primary_completion_date type="Actual">October 20, 2017</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>Parallel Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The patients and the researcher who were responsible for the analyzing of the data were blinded to the randomization results.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain via Visual Analogue Scale</measure>
    <time_frame>Baseline, 1 week</time_frame>
    <description>Change from baseline at 1 week Pain of the patients will be assessed by most widely used and accepted &quot;visual analogue scale&quot;. It consists of a 10 centimeter line marked at one end with &quot;no pain&quot; and at other end with &quot;worst pain ever&quot;. Patients is asked to indicate where on the line he or she rates the pain on the day of presentation, baseline, 1 week of follow-ups. Numerical score is given to it simply by measuring length between &quot;no pain&quot; to patients mark.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thoracic Mobility Index</measure>
    <time_frame>Baseline, 1 week</time_frame>
    <description>Change from baseline at 1 week Thoracic mobility index was measured at the axillar, epigastric and subcostal regions during normal, maximal inspiration and maximal expiration, using a tape measure, baseline,1 week of follow-ups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trunk Balance Test</measure>
    <time_frame>Baseline, 1 week</time_frame>
    <description>Change from baseline at 1 week Functional reach test was performed to assess the trunk balance. In standing position, the distances of sideways and forward reaches were measured as centimeters,baseline,1 week of followups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-minute Walking Test (2MWT)</measure>
    <time_frame>Baseline, 1 week</time_frame>
    <description>Change from baseline at 1 week Two-minute walking test (2MWT), the individual was asked to walk at normal pace for two minutes between the marked start and end points on a 30-meter-long corridor. The walking distance was measured in meters and recorded, baseline,1 week of followups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scoliosis Research Society-22 (SRS-22)</measure>
    <time_frame>Baseline, 6 week</time_frame>
    <description>Change from baseline at 1 week Scoliosis Research Society-22 (SRS-22) questionnaire was used to assess health-related quality of life. The questionnaire assesses pain, self-image, functions, mental health and satisfaction with the treatment. It consists of 22 items, each scored from 1, which is the worst situation, to 5, which is the best situation. The total score ranges from 1 to 5. Patients is asked to answer the questionnaire, baseline, 6 week of follow-ups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Scoliosis Idiopathic</condition>
  <condition>Scoliosis; Adolescence</condition>
  <arm_group>
    <arm_group_label>Rehabilitation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the study group in whom post-operative rehabilitation was provided for 5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobilization group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This is the control group in whom post-operative mobilization was provided for 5 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Post-operative rehabilitation</intervention_name>
    <description>Patients received the exercises programme for five days, 30 minutes, two times per day with supervision by a physical therapist.</description>
    <arm_group_label>Rehabilitation group</arm_group_label>
    <other_name>rehabilitation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Post-operative mobilization</intervention_name>
    <description>Patients received usual mobilization programme for 2-5 minutes, two times per day the five days with supervision by a physical therapist.</description>
    <arm_group_label>Mobilization group</arm_group_label>
    <other_name>mobilization</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. diagnosis of adolescent idiopathic scoliosis,&#xD;
&#xD;
          2. underwent posterior spinal fusion surgery,&#xD;
&#xD;
          3. Cobb's angle of 45 degrees or above,&#xD;
&#xD;
          4. were aged between 10 and 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. diagnosis of neuromuscular or rheumatismal diseases,&#xD;
&#xD;
          2. could not comply with the exercise program,&#xD;
&#xD;
          3. severe surgery-related pulmonary complications&#xD;
&#xD;
          4. complications which would prevent early rehabilitation (such as postoperative&#xD;
             cerebrospinal fluid leak, paraparesis, hemiparesis),&#xD;
&#xD;
          5. surgery-related wound infections.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehmet Fatih Korkmaz, MD</last_name>
    <role>Study Director</role>
    <affiliation>Inonu University Faculy of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zilan Bazancir Apaydın</name>
      <address>
        <city>Ankara</city>
        <zip>06560</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Zilan Bazancir Apaydın</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>post-operative</keyword>
  <keyword>early ambulation</keyword>
  <keyword>posterior fusion surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected IPD, all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>starting 12 months after publication</ipd_time_frame>
    <ipd_access_criteria>Access criteria IPD and additional supporting information will share, analysis of primer and sekonder outcomes and clinical data will share after publication,</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT04403152/ICF_000.pdf</document_url>
    </provided_document>
    <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>February 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT04403152/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04403152
org study id: 2017/53
nct id: NCT04403152
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Scoliosis surgery is a major surgery associated with postoperative pain, loss of physical
      function and pulmonary dysfunction in adolescent idiopathic scoliosis patients (AIS).Despite
      the advanced, various medical treatment methods of pain applied in the postoperative period,
      the mean period of hospitalization is 5 to 7 days. The increasing health expenditures over
      the years have brought along the need for rehabilitation programs conducted in the early
      term. Although early mobilization has been accepted as a rule of thumb by spinal surgeons in
      preventing the performance loss and reducing the causes of morbidity in recent years, the
      investigators could not find any research on postoperative rehabilitation implemented on
      patients under the supervision of a physiotherapist, following scoliosis surgery. The aim of
      this study was to compare effect of five days of intensive postoperative rehabilitation and
      mobilization on length of hospitalization and outcome in patients having scoliosis surgery.
Following spinal surgeries, patients experienced deep somatic pain and severe reflex spasms
      of the muscles located in the surgical site. In addition, pulmonary dysfunction could develop
      due to reduced flexibility of the spine and mobility of the ribs. It is a known fact that
      cardiopulmonary functions in adolescent idiopathic scoliosis patients may not recover even
      two years after surgery. After fusion surgeries in patients with scoliosis have shown that
      the static and dynamic postural control were impaired and that the postural control could
      recover one year after the surgery. The increasing health expenditures over the years have
      brought along the need for rehabilitation programs conducted in the early term.

      Increased postoperative pain, impaired balance reactions in the short, weak EMG responses of
      the trunk muscles, decreased pulmonary capacity and increased health costs have necessitated
      early rehabilitation in patients who had undergone scoliosis surgery. Also, the need for
      further research on the effects of physiotherapeutic approaches on the aforementioned
      functional losses has been indicated in several studies.Although early mobilization has been
      accepted as a rule of thumb by spinal surgeons in preventing the performance loss and
      reducing the causes of morbidity in recent years, the investigators could not find any
      research on postoperative rehabilitation implemented on patients under the supervision of a
      physiotherapist, following scoliosis surgery.

      Therefore, based on these findings, the aim of this study was to compare effect of five days
      of intensive postoperative rehabilitation and mobilization on length of hospitalization and
      outcome in patients having scoliosis surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: The patients and the researcher who were responsible for the analyzing of the data were blinded to the randomization results.
measure: Pain via Visual Analogue Scale
time frame: Baseline, 1 week
description: Change from baseline at 1 week Pain of the patients will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Patients is asked to indicate where on the line he or she rates the pain on the day of presentation, baseline, 1 week of follow-ups. Numerical score is given to it simply by measuring length between "no pain" to patients mark.
measure: Thoracic Mobility Index
time frame: Baseline, 1 week
description: Change from baseline at 1 week Thoracic mobility index was measured at the axillar, epigastric and subcostal regions during normal, maximal inspiration and maximal expiration, using a tape measure, baseline,1 week of follow-ups.
measure: Trunk Balance Test
time frame: Baseline, 1 week
description: Change from baseline at 1 week Functional reach test was performed to assess the trunk balance. In standing position, the distances of sideways and forward reaches were measured as centimeters,baseline,1 week of followups.
measure: 2-minute Walking Test (2MWT)
time frame: Baseline, 1 week
description: Change from baseline at 1 week Two-minute walking test (2MWT), the individual was asked to walk at normal pace for two minutes between the marked start and end points on a 30-meter-long corridor. The walking distance was measured in meters and recorded, baseline,1 week of followups.
measure: Scoliosis Research Society-22 (SRS-22)
time frame: Baseline, 6 week
description: Change from baseline at 1 week Scoliosis Research Society-22 (SRS-22) questionnaire was used to assess health-related quality of life. The questionnaire assesses pain, self-image, functions, mental health and satisfaction with the treatment. It consists of 22 items, each scored from 1, which is the worst situation, to 5, which is the best situation. The total score ranges from 1 to 5. Patients is asked to answer the questionnaire, baseline, 6 week of follow-ups.
arm group label: Rehabilitation group
arm group type: Experimental
description: This is the study group in whom post-operative rehabilitation was provided for 5 days.
arm group label: Mobilization group
arm group type: Active Comparator
description: This is the control group in whom post-operative mobilization was provided for 5 days.
intervention type: Other
intervention name: Post-operative rehabilitation
description: Patients received the exercises programme for five days, 30 minutes, two times per day with supervision by a physical therapist.
arm group label: Rehabilitation group
other name: rehabilitation
intervention type: Other
intervention name: Post-operative mobilization
description: Patients received usual mobilization programme for 2-5 minutes, two times per day the five days with supervision by a physical therapist.
arm group label: Mobilization group
other name: mobilization
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Mehmet Fatih Korkmaz, MD
role: Study Director
affiliation: Inonu University Faculy of Medicine
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Zilan Bazancir Apaydın
investigator title: Principal Investigator
mesh term: Scoliosis
sharing ipd: Yes
ipd description: All collected IPD, all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: starting 12 months after publication
ipd access criteria: Access criteria IPD and additional supporting information will share, analysis of primer and sekonder outcomes and clinical data will share after publication,
provided document: 
provided document: 