<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/NCT02190812</url>
  </required_header>
  <id_info>
    <org_study_id>201302026RINB</org_study_id>
    <nct_id>NCT02190812</nct_id>
  </id_info>
  <brief_title>An Intelligent Evaluation of Wrist Strength for the Elderly People and Its Clinical Application</brief_title>
  <official_title>An Intelligent Evaluation of Wrist Strength for the Elderly People and Its Clinical Application</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Use the system to evaluate of wrist muscle strength.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The muscle strength of involved wrist muscles may be gradually reduced as aging, and impair&#xD;
      their operating skills and even life quality of the elderly. This study has proposed an&#xD;
      evaluation system of wrist muscle strength to grip or twist. This system consists of a torque&#xD;
      meter (FUTEK TDF400) and three plugs/sockets for simulation of common grip or twist in daily&#xD;
      living. This study has completed to evaluate the wrist muscle strength of men and women. In&#xD;
      addition to the effects of age and gender, this study analyzes the influence of applied force&#xD;
      and its plug/socket diameter on the wrist muscle strength. Simultaneously, this study&#xD;
      measured the effect of proper forearm supporter to alleviate pain and improve the wrist and&#xD;
      grip strength in the subjects with tennis elbow. And quantitative surface EMG was used to&#xD;
      analyze the relationship between different forearm muscles involved. In order to achieve the&#xD;
      user-friendly effect, this system intergraded with Cloud service and Bluetooth technology,&#xD;
      and developed a portable and intelligent evaluation system of wrist muscle strength. It can&#xD;
      help medical personnel to assess and analysis of real-time data. The traditional training of&#xD;
      wrist muscle is using grip or grasp a soft tennis ball. In this study a portable grip ball&#xD;
      training system is developed. It consists of a pressure sensor and LabVIEW program. It's&#xD;
      expected to reduce the risk of injury of the elderly in their daily lives.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">April 2015</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>wrist muscle strength</measure>
    <time_frame>two years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Evaluation of Wrist Muscle Strength</condition>
  <arm_group>
    <arm_group_label>Forearm supporter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This study measured the effect of proper forearm supporter to alleviate pain and improve the wrist and grip strength in the subjects with tennis elbow.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grip ball</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study a portable grip ball training system is developed. This study use the grip ball to train the wrist muscle. It's expected to reduce the risk of injury of the elderly in their daily lives.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Forearm supporter</intervention_name>
    <description>The forearm supporter be use in tennis elbow.</description>
    <arm_group_label>Forearm supporter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Grip ball</intervention_name>
    <arm_group_label>Grip ball</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 20 and 75 years old.&#xD;
&#xD;
          -  No significant upper extremity joint pain or nerve palsy.(patients with tennis elbow&#xD;
             typical of lateral elbow pain)&#xD;
&#xD;
          -  Never received surgical treatment of upper limb joints&#xD;
&#xD;
          -  No significant history of cardiovascular disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant disturbance of consciousness&#xD;
&#xD;
          -  Unable to communicate with hearing and speech mode&#xD;
&#xD;
          -  Lack of mental ability&#xD;
&#xD;
          -  Emotional instability&#xD;
&#xD;
          -  Significant systemic disease&#xD;
&#xD;
          -  With upper limb joints or muscles, tendons obvious lesions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lai Jin Shin</last_name>
      <phone>886-972651256</phone>
      <email>jslai@ntu.edu.tw</email>
    </contact>
    <contact_backup>
      <last_name>Lin Yu Tse</last_name>
      <phone>886-928708103</phone>
      <email>s97323055@mail1.ncnu.edu.tw</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 13, 2014</last_update_submitted>
  <last_update_submitted_qc>July 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>wrist muscle strength</keyword>
  <!-- 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/NCT02190812
org study id: 201302026RINB
nct id: NCT02190812
lead sponsor: 
has dmc: Yes
Use the system to evaluate of wrist muscle strength.
The muscle strength of involved wrist muscles may be gradually reduced as aging, and impair
      their operating skills and even life quality of the elderly. This study has proposed an
      evaluation system of wrist muscle strength to grip or twist. This system consists of a torque
      meter (FUTEK TDF400) and three plugs/sockets for simulation of common grip or twist in daily
      living. This study has completed to evaluate the wrist muscle strength of men and women. In
      addition to the effects of age and gender, this study analyzes the influence of applied force
      and its plug/socket diameter on the wrist muscle strength. Simultaneously, this study
      measured the effect of proper forearm supporter to alleviate pain and improve the wrist and
      grip strength in the subjects with tennis elbow. And quantitative surface EMG was used to
      analyze the relationship between different forearm muscles involved. In order to achieve the
      user-friendly effect, this system intergraded with Cloud service and Bluetooth technology,
      and developed a portable and intelligent evaluation system of wrist muscle strength. It can
      help medical personnel to assess and analysis of real-time data. The traditional training of
      wrist muscle is using grip or grasp a soft tennis ball. In this study a portable grip ball
      training system is developed. It consists of a pressure sensor and LabVIEW program. It's
      expected to reduce the risk of injury of the elderly in their daily lives.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: wrist muscle strength
time frame: two years
arm group label: Forearm supporter
arm group type: Experimental
description: This study measured the effect of proper forearm supporter to alleviate pain and improve the wrist and grip strength in the subjects with tennis elbow.
arm group label: Grip ball
arm group type: Experimental
description: In this study a portable grip ball training system is developed. This study use the grip ball to train the wrist muscle. It's expected to reduce the risk of injury of the elderly in their daily lives.
intervention type: Device
intervention name: Forearm supporter
description: The forearm supporter be use in tennis elbow.
arm group label: Forearm supporter
intervention type: Device
intervention name: Grip ball
arm group label: Grip ball
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: Taiwan
responsible party type: Sponsor