<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/NCT03248206</url>
  </required_header>
  <id_info>
    <org_study_id>A-ER-105-257</org_study_id>
    <nct_id>NCT03248206</nct_id>
  </id_info>
  <brief_title>Home-based Proprioceptive Neuromuscular Facilitation for Subjects With Type 2 Diabetes Mellitus</brief_title>
  <official_title>Effects of a Home-based Proprioceptive Neuromuscular Facilitation in Conjunction With Tendon Gliding Exercises on Sensorimotor Function in Upper Extremity of Subjects With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</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>
      In this research work, the concept of strengthening technique of proprioceptive neuromuscular&#xD;
      facilitation (PNF) incorporated with tendon gliding exercise (TGE) will be used to improve&#xD;
      neuromuscular function of upper extremity of patients with diabetes mellitus. The first&#xD;
      specific aim of the study is to examine the effects of home-based PNF exercise on the motor,&#xD;
      sensation and functional performance parameters of upper extremity of the patients with&#xD;
      diabetes mellitus. In addition, whether adding a tendon gliding exercise (TGE) to the&#xD;
      home-based PNF exercises can provide better treatment effects for the patients with diabetes&#xD;
      mellitus will also been investigated in this study. One of the hypothesis of this study is&#xD;
      the prescribing home-based PNF exercise program has a positive treatment effect on&#xD;
      neuromuscular function of the upper extremity of patients with diabetes mellitus. And,the&#xD;
      other is home-based PNF in conjunction with TGE provides better benefits for neuromuscular&#xD;
      function of the upper extremity of patients with diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">December 14, 2018</completion_date>
  <primary_completion_date type="Actual">August 14, 2018</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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>determine the touch-pressure threshold of the hands</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline result of Nerve conduction study (NCS) at 12 weeks</measure>
    <time_frame>pre-intervention (week 0) and follow-up evaluation (week 24)</time_frame>
    <description>determine nerve condition through detection of the amplitude of the sensory and motor nerve action potential</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline result of pinch-holding-up activity test at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>sensorimotor control of a hand</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline result of Purdue pegboard test at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>determine fine fingertip dexterity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline result of Minnesota Manual Dexterity Test at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>determine unilateral and bilateral gross motor coordination of upper extremity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline result of Manual tactile test at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>determine active touching sensation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline result of Grasp and pinch power at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>Grip strength of the hands will be assessed with a Jamar dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline result of pinch power at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>Pinch power is measured with a pinch gauge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline result of of shoulder flexion assessing by Micro FET hand-held dynamometer at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>Peak force of shoulder flexion (N) will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline result of shoulder internal rotation assessing by Micro FET hand-held dynamometer at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>Peak force of shoulder internal rotation (N) will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline result of shoulder external rotation assessing by Micro FET hand-held dynamometer at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>Peak force of shoulder external rotation (N) will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline result of peak torque of shoulder external rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>Peak torque of shoulder external rotation (N⋅m) will be obtained</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline result of peak torque of shoulder internal rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks</measure>
    <time_frame>pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)</time_frame>
    <description>Peak torque (PT) of shoulder internal rotation (N⋅m) will be obtained</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>PNF exercise program group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The PNF home-program exercise group: perform grade 1&amp;2 two times a day, at least 3 times per week, for 3 sets of 12 repetitions to increase neuromuscular and musculoskeletal endurance. (Grade 1: The participants performs the diagonal- spiral pattern that will enhance the strength or movement of a targeted muscle or muscle group.; Grade 2:The participants performs PNF exercise with elastic bands . )</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PNF in conjunction with tendon gliding exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in PNF in conjunction with TGE group will perform PNF grade 1&amp;2 as well as tendon gliding exercise two times a day, at least 3 times per week, for 3 sets of 10 repetitions. Training duration for both the two groups is twelve weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>lifestyle changes</intervention_name>
    <description>Providing a home-based exercise program supervised by therapists can be an acceptable strategy with the characteristics of convenience and inexpensiveness to promote neuromuscular and functional component for the patients with diabetes mellitus.</description>
    <arm_group_label>PNF exercise program group</arm_group_label>
    <arm_group_label>PNF in conjunction with tendon gliding exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study participants will include clinically defined diabetic patients who are diagnosed&#xD;
             based on the 1997 criteria of the American Diabetes Association. The inclusion&#xD;
             criteria of the enrolled subjects are who suffered from neuropathy as diagnosed by&#xD;
             abnormalities in either a nerve conduction study and / or quantitative sensory&#xD;
             testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DM patients with (1) traumatic nerve injuries of the upper limbs, (2) trauma to the&#xD;
             hand or congenital anomalies of the wrist and hand, (3) skin infections or disease,&#xD;
             (4) known vascular complications of diabetes, such as stroke may have compromised the&#xD;
             physical integrity of the patient, (5) grade 2 or higher arterial hypertension&#xD;
             (&gt;160/100 mmHg) or (6) cognitive deficits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Cheng-Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT03248206
org study id: A-ER-105-257
nct id: NCT03248206
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this research work, the concept of strengthening technique of proprioceptive neuromuscular
      facilitation (PNF) incorporated with tendon gliding exercise (TGE) will be used to improve
      neuromuscular function of upper extremity of patients with diabetes mellitus. The first
      specific aim of the study is to examine the effects of home-based PNF exercise on the motor,
      sensation and functional performance parameters of upper extremity of the patients with
      diabetes mellitus. In addition, whether adding a tendon gliding exercise (TGE) to the
      home-based PNF exercises can provide better treatment effects for the patients with diabetes
      mellitus will also been investigated in this study. One of the hypothesis of this study is
      the prescribing home-based PNF exercise program has a positive treatment effect on
      neuromuscular function of the upper extremity of patients with diabetes mellitus. And,the
      other is home-based PNF in conjunction with TGE provides better benefits for neuromuscular
      function of the upper extremity of patients with diabetes mellitus.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: determine the touch-pressure threshold of the hands
measure: Change from baseline result of Nerve conduction study (NCS) at 12 weeks
time frame: pre-intervention (week 0) and follow-up evaluation (week 24)
description: determine nerve condition through detection of the amplitude of the sensory and motor nerve action potential
measure: Change from baseline result of pinch-holding-up activity test at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: sensorimotor control of a hand
measure: Change from baseline result of Purdue pegboard test at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: determine fine fingertip dexterity
measure: Change from baseline result of Minnesota Manual Dexterity Test at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: determine unilateral and bilateral gross motor coordination of upper extremity
measure: Change from baseline result of Manual tactile test at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: determine active touching sensation
measure: Change from baseline result of Grasp and pinch power at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: Grip strength of the hands will be assessed with a Jamar dynamometer
measure: Change from baseline result of pinch power at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: Pinch power is measured with a pinch gauge
measure: Change from baseline result of of shoulder flexion assessing by Micro FET hand-held dynamometer at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: Peak force of shoulder flexion (N) will be measured
measure: Change from baseline result of shoulder internal rotation assessing by Micro FET hand-held dynamometer at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: Peak force of shoulder internal rotation (N) will be measured
measure: Change from baseline result of shoulder external rotation assessing by Micro FET hand-held dynamometer at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: Peak force of shoulder external rotation (N) will be measured
measure: Change from baseline result of peak torque of shoulder external rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: Peak torque of shoulder external rotation (N⋅m) will be obtained
measure: Change from baseline result of peak torque of shoulder internal rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
description: Peak torque (PT) of shoulder internal rotation (N⋅m) will be obtained
arm group label: PNF exercise program group
arm group type: Active Comparator
description: The PNF home-program exercise group: perform grade 1&2 two times a day, at least 3 times per week, for 3 sets of 12 repetitions to increase neuromuscular and musculoskeletal endurance. (Grade 1: The participants performs the diagonal- spiral pattern that will enhance the strength or movement of a targeted muscle or muscle group.; Grade 2:The participants performs PNF exercise with elastic bands . )
arm group label: PNF in conjunction with tendon gliding exercise group
arm group type: Experimental
description: Patients in PNF in conjunction with TGE group will perform PNF grade 1&2 as well as tendon gliding exercise two times a day, at least 3 times per week, for 3 sets of 10 repetitions. Training duration for both the two groups is twelve weeks.
intervention type: Behavioral
intervention name: lifestyle changes
description: Providing a home-based exercise program supervised by therapists can be an acceptable strategy with the characteristics of convenience and inexpensiveness to promote neuromuscular and functional component for the patients with diabetes mellitus.
arm group label: PNF exercise program group
arm group label: PNF in conjunction with tendon gliding exercise group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2