<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/NCT04484480</url>
  </required_header>
  <id_info>
    <org_study_id>Gait DM</org_study_id>
    <nct_id>NCT04484480</nct_id>
  </id_info>
  <brief_title>Balance and Motion Coordination Parameters Can be Improved in Patients With Type 2 Diabetes</brief_title>
  <official_title>Balance and Motion Coordination Parameters Can be Improved in Patients - Non-randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</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>
      Diabetes mellitus type II (DMII) causes many complications, including retinopathy and&#xD;
      peripheral neuropathy. These complications are well understood and believed to contribute to&#xD;
      gait instability and increase the risk of falls. Poor balance control and increased falling&#xD;
      risk have also been reported in people with diabetic peripheral neuropathy (DPN).&#xD;
&#xD;
      Patients with DPN are at an increased risk of falling due to the decreased proprioceptive&#xD;
      feedbacks. Effective balance training should improve instabilities of postural control in&#xD;
      patients with DPN. For this purpose, evaluations and balance training was designed.&#xD;
&#xD;
      The goal of our study was to establish values for proprioception, balance, muscle&#xD;
      coordination and strength in patients with DMII, who underwent biofeedback balance training&#xD;
      using the Biodex Balance System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is estimated that by the end of 2017 year, there will be 462 millions of patients&#xD;
      suffering from diabetes mellitus type II (DMII), what is about 6% of world population (4,4%&#xD;
      between 15 and 49 years of age, 15% between 50 and 69 years and 22% of patients older than 70&#xD;
      years). It is predicted that by the beginning of 2030, number of cases on 100000 people will&#xD;
      grow from 6059 up to 7079. There are studies proving that cardiovascular complications&#xD;
      related to the diabetes are responsible for 4 millions of deaths annually. The newest&#xD;
      epidemiological data suggest that growing number of DMII cases is no longer a problem in&#xD;
      developed countries but also affects developing ones. As potential risk factors, well proved&#xD;
      in the literature authors reported alcoholism, nicotinism, high body-mass index (BMI) and&#xD;
      positive family history. It is therefore anticipated that the prevalence of one of its common&#xD;
      complications, a diabetic peripheral neuropathy (DPN), will increase as well. It is broadly&#xD;
      recognized that a DPN leads to a decrement in distal lower limb sensory function; however,&#xD;
      there is also a neuropathy-related decrease in distal motor function, even among those with&#xD;
      relatively mild diabetic disease. It is well proven in the literature, that diabetes mellitus&#xD;
      influences negatively function of peripheral nervous system by damaging sensory fibers. A&#xD;
      high risk of falls has been reported in the diabetic population, with an overall incidence of&#xD;
      1.25 falls/person-year.It was proven that short-period strength and balance exercises do not&#xD;
      improves diabetic patients quality of life However they have positive influence on the&#xD;
      functional outcome of those people. Influence of DMII on motion system is not limited only to&#xD;
      the peripheral nervous system. It also affects structures of cerebrum such as: cerebral&#xD;
      cortex, cerebellum or basal nuclei. DMII affects motor and somatosensory cerebral atrophy&#xD;
      what leads to changes in projection tracts associated with them. In cerebellum it affects on&#xD;
      the vermis and parts of lobes responsible for receiving impulses from the spinal cord and&#xD;
      controlling proximal parts of muscles, which are crucial for movement coordination during&#xD;
      gait. Disorders caused by DMII in basal nuclei result in longer response time and slower gait&#xD;
      velocity. Together with pharmacological and dietary interventions, exercise interventions&#xD;
      including resistance training, represent the cornerstones of type 2 diabetes management. In&#xD;
      addition to the beneficial effects of exercise interventions on glycemic control and on the&#xD;
      cardiovascular risk factors associated with type 2 diabetes, physical exercise is an&#xD;
      effective intervention to improve muscle strength, power output, cardiovascular function and&#xD;
      functional capacity in elderly diabetic patients. In elderly diabetics with severe functional&#xD;
      decline, multicomponent exercise programs composed of resistance, endurance, balance and gait&#xD;
      retraining should be employed to increase functional capacity and quality of life and to&#xD;
      avoid disability and falls. The aim of the study was to evaluate balance and motor&#xD;
      coordination parameters in patients treated for type 2 diabetes who received&#xD;
      biofeedback-equivalent training using the Biodex dynamometric platform.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigator an outcomes assessor were blinded for the information whether analyzed participant was in the interventional group or control one.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fall risk test</measure>
    <time_frame>3-months after inclusion to the study</time_frame>
    <description>Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials. The lower the values of the fall index were, the better the result.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General Stability Index</measure>
    <time_frame>3-months after inclusion to the study</time_frame>
    <description>Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frontal-Posterior Stability Index)</measure>
    <time_frame>3-months after inclusion to the study</time_frame>
    <description>Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medial-Lateral Stability Index</measure>
    <time_frame>3-months after inclusion to the study</time_frame>
    <description>Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Gait Disorders, Neurologic</condition>
  <arm_group>
    <arm_group_label>Balance training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients included in the study group, who received 3-month proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients included in the control group who did not received any intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Balance training</intervention_name>
    <description>Proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.</description>
    <arm_group_label>Balance training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willingness to participate in the study&#xD;
&#xD;
          -  age over 65&#xD;
&#xD;
          -  diagnosed type 2 diabetes, subjected to pharmacological treatment (study group)&#xD;
&#xD;
          -  no type 2 diabetes (control group)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unwillingness to participate in the study&#xD;
&#xD;
          -  age below 65 years&#xD;
&#xD;
          -  surgical intervention in the lower limbs or spine during the last 6 months&#xD;
&#xD;
          -  symptoms of osteoarthritis or pain of another origin around the lower limbs or spine&#xD;
&#xD;
          -  rheumatic diseases (eg. rheumatoid arthritis, ankylosing spondylitis)&#xD;
&#xD;
          -  diagnosed neuromuscular disease&#xD;
&#xD;
          -  strongly manifested imbalances due to impairment of central or peripheral nervous&#xD;
             system&#xD;
&#xD;
          -  neurological disorders with dizziness, nystagmus, dermatologic or profound&#xD;
             (cerebrospinal syndrome, dizziness, multiple sclerosis, Parkinson's disease, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Artur Stolarczyk, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Othopedics and Rehabilitation, Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowieckie</state>
        <zip>03-984</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>gait</keyword>
  <keyword>balance</keyword>
  <keyword>falls</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The datasets used during the current study are not publicly available because of patient integrity but are available from the corresponding author on reasonable request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be available on reasonable request for 36 months</ipd_time_frame>
  </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/NCT04484480
org study id: Gait DM
nct id: NCT04484480
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diabetes mellitus type II (DMII) causes many complications, including retinopathy and
      peripheral neuropathy. These complications are well understood and believed to contribute to
      gait instability and increase the risk of falls. Poor balance control and increased falling
      risk have also been reported in people with diabetic peripheral neuropathy (DPN).

      Patients with DPN are at an increased risk of falling due to the decreased proprioceptive
      feedbacks. Effective balance training should improve instabilities of postural control in
      patients with DPN. For this purpose, evaluations and balance training was designed.

      The goal of our study was to establish values for proprioception, balance, muscle
      coordination and strength in patients with DMII, who underwent biofeedback balance training
      using the Biodex Balance System.
It is estimated that by the end of 2017 year, there will be 462 millions of patients
      suffering from diabetes mellitus type II (DMII), what is about 6% of world population (4,4%
      between 15 and 49 years of age, 15% between 50 and 69 years and 22% of patients older than 70
      years). It is predicted that by the beginning of 2030, number of cases on 100000 people will
      grow from 6059 up to 7079. There are studies proving that cardiovascular complications
      related to the diabetes are responsible for 4 millions of deaths annually. The newest
      epidemiological data suggest that growing number of DMII cases is no longer a problem in
      developed countries but also affects developing ones. As potential risk factors, well proved
      in the literature authors reported alcoholism, nicotinism, high body-mass index (BMI) and
      positive family history. It is therefore anticipated that the prevalence of one of its common
      complications, a diabetic peripheral neuropathy (DPN), will increase as well. It is broadly
      recognized that a DPN leads to a decrement in distal lower limb sensory function; however,
      there is also a neuropathy-related decrease in distal motor function, even among those with
      relatively mild diabetic disease. It is well proven in the literature, that diabetes mellitus
      influences negatively function of peripheral nervous system by damaging sensory fibers. A
      high risk of falls has been reported in the diabetic population, with an overall incidence of
      1.25 falls/person-year.It was proven that short-period strength and balance exercises do not
      improves diabetic patients quality of life However they have positive influence on the
      functional outcome of those people. Influence of DMII on motion system is not limited only to
      the peripheral nervous system. It also affects structures of cerebrum such as: cerebral
      cortex, cerebellum or basal nuclei. DMII affects motor and somatosensory cerebral atrophy
      what leads to changes in projection tracts associated with them. In cerebellum it affects on
      the vermis and parts of lobes responsible for receiving impulses from the spinal cord and
      controlling proximal parts of muscles, which are crucial for movement coordination during
      gait. Disorders caused by DMII in basal nuclei result in longer response time and slower gait
      velocity. Together with pharmacological and dietary interventions, exercise interventions
      including resistance training, represent the cornerstones of type 2 diabetes management. In
      addition to the beneficial effects of exercise interventions on glycemic control and on the
      cardiovascular risk factors associated with type 2 diabetes, physical exercise is an
      effective intervention to improve muscle strength, power output, cardiovascular function and
      functional capacity in elderly diabetic patients. In elderly diabetics with severe functional
      decline, multicomponent exercise programs composed of resistance, endurance, balance and gait
      retraining should be employed to increase functional capacity and quality of life and to
      avoid disability and falls. The aim of the study was to evaluate balance and motor
      coordination parameters in patients treated for type 2 diabetes who received
      biofeedback-equivalent training using the Biodex dynamometric platform.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: Investigator an outcomes assessor were blinded for the information whether analyzed participant was in the interventional group or control one.
measure: Fall risk test
time frame: 3-months after inclusion to the study
description: Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials. The lower the values of the fall index were, the better the result.
measure: General Stability Index
time frame: 3-months after inclusion to the study
description: Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials
measure: Frontal-Posterior Stability Index)
time frame: 3-months after inclusion to the study
description: Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials
measure: Medial-Lateral Stability Index
time frame: 3-months after inclusion to the study
description: Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials
arm group label: Balance training
arm group type: Experimental
description: Patients included in the study group, who received 3-month proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.
arm group label: Control group
arm group type: No Intervention
description: Patients included in the control group who did not received any intervention
intervention type: Procedure
intervention name: Balance training
description: Proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.
arm group label: Balance training
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Artur Stolarczyk, MD, PhD
role: Principal Investigator
affiliation: Medical University of Warsaw
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Nervous System Diseases
mesh term: Gait Disorders, Neurologic
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: The datasets used during the current study are not publicly available because of patient integrity but are available from the corresponding author on reasonable request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be available on reasonable request for 36 months