<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/NCT03239301</url>
  </required_header>
  <id_info>
    <org_study_id>1240</org_study_id>
    <nct_id>NCT03239301</nct_id>
  </id_info>
  <brief_title>Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients</brief_title>
  <official_title>Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Physical Medicine and Rehabilitation Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Physical Medicine and Rehabilitation Education 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>
      Study design: Controlled Trial Objective: To evaluate the effectiveness of robotic-assisted&#xD;
      training of forearm and hand functions in spinal cord injury patients Setting: Ankara&#xD;
      Physical Medicine and Rehabilitation Training and Research Hospital, Turkey Methods: Forty&#xD;
      patients were allocated into robotic and control groups. Both groups received conventional&#xD;
      rehabilitation program for four weeks. Moreover, robotic group received robotic&#xD;
      rehabilitation program tailored to the patient five times a week (each session of 30 min).&#xD;
&#xD;
      Baseline data and post-intervention data was compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Independence Measure</measure>
    <time_frame>Four weeks</time_frame>
    <description>Scale Evaluating the Functionality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spinal Cord Independence Measure III</measure>
    <time_frame>Four weeks</time_frame>
    <description>Scale Evaluating the Functionality and independence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form-36</measure>
    <time_frame>Four weeks</time_frame>
    <description>Scale Evaluation the activities of daily living</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Spinal Cord Injury Cervical</condition>
  <arm_group>
    <arm_group_label>Conventional Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional rehabilitation program consisted range of motion (ROM) exercises, balance and coordination training, progressive resistive exercises, posture training, gait training, and occupational therapy as much as the patients tolerated. Conventional rehabilitation was tailored to the patient considering his requires and expectancies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Robotic Rehabilitation + Conventional Rehab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Armeo Spring HocomAG Inc. (Volketswil, Switzerland) device was used in robot assisted upper limb rehabilitation program. A</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Rehabilitation</intervention_name>
    <description>Conventional rehabilitation program consisted range of motion (ROM) exercises, balance and coordination training, progressive resistive exercises, posture training, gait training, and occupational therapy as much as the patients tolerated. Conventional rehabilitation was tailored to the patient considering his requires and expectancies.</description>
    <arm_group_label>Conventional Rehabilitation</arm_group_label>
    <arm_group_label>Robotic Rehabilitation + Conventional Rehab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robotic REhabilitation</intervention_name>
    <description>The Armeo Spring HocomAG Inc. (Volketswil, Switzerland) device was used in robot assisted upper limb rehabilitation program. Assistive component of the robotic arm was adjusted in accordance with motor level of each patient. Variety and difficulty of games were chosen according to the ability and functional status of the patients. Variety and difficulty level of the games were modified according to progress of patients by the same physiotherapist.</description>
    <arm_group_label>Robotic Rehabilitation + Conventional Rehab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages between 18-50&#xD;
&#xD;
          -  Cervical Level of Spinal Cord Injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe upper extremity contractures in the joints&#xD;
&#xD;
          -  Intensive spasticity (Ashworth 3-4)&#xD;
&#xD;
          -  Shoulder pain that causes exercise intolerance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ankara Fizik Tedavi ve REhabilitasyon Eğitim ve Araştırma Hastanesi</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Physical MEdicine and REhabilitation Trainign and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara Physical Medicine and Rehabilitation Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Timur Ekiz</investigator_full_name>
    <investigator_title>Medical Doctor, Physical and Rehabilitation Medicine Specialist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03239301
org study id: 1240
nct id: NCT03239301
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study design: Controlled Trial Objective: To evaluate the effectiveness of robotic-assisted
      training of forearm and hand functions in spinal cord injury patients Setting: Ankara
      Physical Medicine and Rehabilitation Training and Research Hospital, Turkey Methods: Forty
      patients were allocated into robotic and control groups. Both groups received conventional
      rehabilitation program for four weeks. Moreover, robotic group received robotic
      rehabilitation program tailored to the patient five times a week (each session of 30 min).

      Baseline data and post-intervention data was compared.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Functional Independence Measure
time frame: Four weeks
description: Scale Evaluating the Functionality
measure: Spinal Cord Independence Measure III
time frame: Four weeks
description: Scale Evaluating the Functionality and independence
measure: Short Form-36
time frame: Four weeks
description: Scale Evaluation the activities of daily living
arm group label: Conventional Rehabilitation
arm group type: Active Comparator
description: Conventional rehabilitation program consisted range of motion (ROM) exercises, balance and coordination training, progressive resistive exercises, posture training, gait training, and occupational therapy as much as the patients tolerated. Conventional rehabilitation was tailored to the patient considering his requires and expectancies.
arm group label: Robotic Rehabilitation + Conventional Rehab
arm group type: Active Comparator
description: The Armeo Spring HocomAG Inc. (Volketswil, Switzerland) device was used in robot assisted upper limb rehabilitation program. A
intervention type: Procedure
intervention name: Conventional Rehabilitation
description: Conventional rehabilitation program consisted range of motion (ROM) exercises, balance and coordination training, progressive resistive exercises, posture training, gait training, and occupational therapy as much as the patients tolerated. Conventional rehabilitation was tailored to the patient considering his requires and expectancies.
arm group label: Conventional Rehabilitation
arm group label: Robotic Rehabilitation + Conventional Rehab
intervention type: Procedure
intervention name: Robotic REhabilitation
description: The Armeo Spring HocomAG Inc. (Volketswil, Switzerland) device was used in robot assisted upper limb rehabilitation program. Assistive component of the robotic arm was adjusted in accordance with motor level of each patient. Variety and difficulty of games were chosen according to the ability and functional status of the patients. Variety and difficulty level of the games were modified according to progress of patients by the same physiotherapist.
arm group label: Robotic Rehabilitation + Conventional Rehab
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ankara Physical Medicine and Rehabilitation Education and Research Hospital
investigator full name: Timur Ekiz
investigator title: Medical Doctor, Physical and Rehabilitation Medicine Specialist
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: Undecided