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/NCT05971784</url>
    </required_header>
    <id_info>
      <org_study_id>6- PD-Balance-Telereh-RCT</org_study_id>
      <nct_id>NCT05971784</nct_id>
    </id_info>
    <brief_title>The Effect of Upper Extremity Telerehabilitation on Balance and Gait</brief_title>
    <official_title>The Effect of Upper Extremity Telerehabilitation on Balance and Gait in Parkinson's Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Cumhuriyet University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Gazi University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Parkinson's Disease (PD) is a disease that affects the upper extremity functional skills with&#xD;
        clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in&#xD;
        the daily living activities of the patients. The influence of fine dexterity, reaching, and&#xD;
        grasping movements greatly affects the daily living activities of the patients. Medical&#xD;
        treatment and surgical approaches are frequently used among the treatment options for PD&#xD;
        today. Physiotherapy and rehabilitation approaches for progressive functional loss in PD,&#xD;
        together with optimal medical and surgical treatment, form the basis of PD treatment.&#xD;
        Recently, it has been stated that intensive and task-specific rehabilitation interventions in&#xD;
        the field of physiotherapy and rehabilitation will be more effective than traditional&#xD;
        rehabilitation approaches. On the other hand, telerehabilitation approaches, the use of which&#xD;
        has increased rapidly due to technological developments in recent times, enables the delivery&#xD;
        of rehabilitation services to patients in distant places by using communication technologies.&#xD;
        For this purpose, it is highly valuable to implement a task-oriented training (TOT) program&#xD;
        based on motor learning-based principles, which consists of intense exercise content, through&#xD;
        telerehabilitation. Although there are very few studies investigating the effectiveness of&#xD;
        telerehabilitation-based TOT in PD, these studies have shown that upper extremity motor&#xD;
        performance, activities of daily living, and quality of life are improved. On the other hand,&#xD;
        no study has been found showing the effect of upper extremity TOT applied through&#xD;
        telerehabilitation on balance and walking. Therefore, there is a need to investigate the&#xD;
        effectiveness of telerehabilitation-based TOT exercises on balance and walking.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a randomized controlled study. The patients will be randomly divided into two&#xD;
        groups exercise and control. Balance and walking exercises consisting of 3 days a week for 6&#xD;
        weeks will be given to both groups as a home program. In addition, the exercise group will&#xD;
        receive Task-oriented Training (TOT) based telerehabilitation via video conferencing 3 days a&#xD;
        week for 6 weeks. TOT will be formed from daily life activities such as reaching out,&#xD;
        grasping, writing, and manual skills, which are frequently used in daily life. As the outcome&#xD;
        measures, disease severity, and disability, balance, and gait will be evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 25, 2023</start_date>
    <completion_date type="Anticipated">December 10, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 10, 2023</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>Two groups as exercise group and control group</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Static Balance- Baseline</measure>
      <time_frame>Assessment will be conducted before the intervention</time_frame>
      <description>Assessment will be made with a Biodex Balance System</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Static Balance- Post intervention</measure>
      <time_frame>Assessment will be conducted immediately after the intervention</time_frame>
      <description>Assessment will be made with a Biodex Balance System</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait speed- Baseline</measure>
      <time_frame>Assessment will be conducted before the intervention</time_frame>
      <description>Assessment will be made with a wearable movement analysis system (G-walk) during gait</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait speed- Post intervention</measure>
      <time_frame>Assessment will be conducted immediately after the intervention</time_frame>
      <description>Assessment will be made with a wearable movement analysis system (G-walk) during gait</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Balance- Baseline</measure>
      <time_frame>Assessment will be conducted before the intervention</time_frame>
      <description>Assessment will be made with the Berg Balance Scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Balance- Post intervention</measure>
      <time_frame>Assessment will be conducted immediately after the intervention</time_frame>
      <description>Assessment will be made with the Berg Balance Scale</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">14</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Telerehabilitation group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to the exercise program consisting of balance and walking activities, the group will receive task-oriented upper extremity training via telerehabilitation accompanied by a physiotherapist.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The group that will receive a home exercise program consisting of only balance and walking activities</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Telerehabilitation Group</intervention_name>
      <description>The group that will receive upper extremity training via telerehabilitation in addition to an exercise program consisting of balance and walking activities</description>
      <arm_group_label>Telerehabilitation group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control Group</intervention_name>
      <description>The group that will receive an exercise program consisting of balance and walking activities</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  40- 80 years of age&#xD;
  &#xD;
            -  Having diagnosed with &quot;Parkinson's Disease&quot; by a specialist physician&#xD;
  &#xD;
            -  Having between 1-3 stages according to the Hoehn and Yahr Scale&#xD;
  &#xD;
            -  Mini-Mental Test score more than or equal 24&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect&#xD;
          the research results&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation</name>
        <address>
          <city>Sivas</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Eldemir S, Guclu-Gunduz A, Eldemir K, Saygili F, Yilmaz R, Akbostanci MC. The effect of task-oriented circuit training-based telerehabilitation on upper extremity motor functions in patients with Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2023 Apr;109:105334. doi: 10.1016/j.parkreldis.2023.105334. Epub 2023 Feb 28.</citation>
      <PMID>36917914</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cumhuriyet University</investigator_affiliation>
      <investigator_full_name>Sefa Eldemir</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Parkinson disease</keyword>
    <keyword>Task oriented training</keyword>
    <keyword>Balance</keyword>
    <keyword>Gait</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to share data but when the statistical analysis of all data is made, all results will be shared.</ipd_description>
    </patient_data>
    <!-- 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/NCT05971784
  org study id: 6- PD-Balance-Telereh-RCT
  nct id: NCT05971784
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Parkinson's Disease (PD) is a disease that affects the upper extremity functional skills with
        clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in
        the daily living activities of the patients. The influence of fine dexterity, reaching, and
        grasping movements greatly affects the daily living activities of the patients. Medical
        treatment and surgical approaches are frequently used among the treatment options for PD
        today. Physiotherapy and rehabilitation approaches for progressive functional loss in PD,
        together with optimal medical and surgical treatment, form the basis of PD treatment.
        Recently, it has been stated that intensive and task-specific rehabilitation interventions in
        the field of physiotherapy and rehabilitation will be more effective than traditional
        rehabilitation approaches. On the other hand, telerehabilitation approaches, the use of which
        has increased rapidly due to technological developments in recent times, enables the delivery
        of rehabilitation services to patients in distant places by using communication technologies.
        For this purpose, it is highly valuable to implement a task-oriented training (TOT) program
        based on motor learning-based principles, which consists of intense exercise content, through
        telerehabilitation. Although there are very few studies investigating the effectiveness of
        telerehabilitation-based TOT in PD, these studies have shown that upper extremity motor
        performance, activities of daily living, and quality of life are improved. On the other hand,
        no study has been found showing the effect of upper extremity TOT applied through
        telerehabilitation on balance and walking. Therefore, there is a need to investigate the
        effectiveness of telerehabilitation-based TOT exercises on balance and walking.
  This study is a randomized controlled study. The patients will be randomly divided into two
        groups exercise and control. Balance and walking exercises consisting of 3 days a week for 6
        weeks will be given to both groups as a home program. In addition, the exercise group will
        receive Task-oriented Training (TOT) based telerehabilitation via video conferencing 3 days a
        week for 6 weeks. TOT will be formed from daily life activities such as reaching out,
        grasping, writing, and manual skills, which are frequently used in daily life. As the outcome
        measures, disease severity, and disability, balance, and gait will be evaluated.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two groups as exercise group and control group
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: Static Balance- Baseline
  time frame: Assessment will be conducted before the intervention
  description: Assessment will be made with a Biodex Balance System
  measure: Static Balance- Post intervention
  time frame: Assessment will be conducted immediately after the intervention
  description: Assessment will be made with a Biodex Balance System
  measure: Gait speed- Baseline
  time frame: Assessment will be conducted before the intervention
  description: Assessment will be made with a wearable movement analysis system (G-walk) during gait
  measure: Gait speed- Post intervention
  time frame: Assessment will be conducted immediately after the intervention
  description: Assessment will be made with a wearable movement analysis system (G-walk) during gait
  measure: Balance- Baseline
  time frame: Assessment will be conducted before the intervention
  description: Assessment will be made with the Berg Balance Scale
  measure: Balance- Post intervention
  time frame: Assessment will be conducted immediately after the intervention
  description: Assessment will be made with the Berg Balance Scale
  arm group label: Telerehabilitation group
  arm group type: Experimental
  description: In addition to the exercise program consisting of balance and walking activities, the group will receive task-oriented upper extremity training via telerehabilitation accompanied by a physiotherapist.
  arm group label: Control group
  arm group type: Experimental
  description: The group that will receive a home exercise program consisting of only balance and walking activities
  intervention type: Other
  intervention name: Telerehabilitation Group
  description: The group that will receive upper extremity training via telerehabilitation in addition to an exercise program consisting of balance and walking activities
  arm group label: Telerehabilitation group
  intervention type: Other
  intervention name: Control Group
  description: The group that will receive an exercise program consisting of balance and walking activities
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  citation: Eldemir S, Guclu-Gunduz A, Eldemir K, Saygili F, Yilmaz R, Akbostanci MC. The effect of task-oriented circuit training-based telerehabilitation on upper extremity motor functions in patients with Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2023 Apr;109:105334. doi: 10.1016/j.parkreldis.2023.105334. Epub 2023 Feb 28.
  PMID: 36917914
  responsible party type: Principal Investigator
  investigator affiliation: Cumhuriyet University
  investigator full name: Sefa Eldemir
  investigator title: Principal Investigator
  mesh term: Parkinson Disease
  sharing ipd: No
  ipd description: There is no plan to share data but when the statistical analysis of all data is made, all results will be shared.