<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/NCT03767413</url>
  </required_header>
  <id_info>
    <org_study_id>8810025277</org_study_id>
    <nct_id>NCT03767413</nct_id>
  </id_info>
  <brief_title>The Effects of Mental Practice Combined With Proprioceptive Neuromuscular Facilitation on Muscle Strength of Upper Limb and Hand Grip</brief_title>
  <official_title>The Effects of Mental Practice Combined With Proprioceptive Neuromuscular Facilitation on Muscle Strength of Upper Limb and Hand Grip</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jazan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jazan</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>
      Influence of mental practice and proprioceptive neuromuscular facilitation on muscle strength&#xD;
      of upper limb and hand grip will be measured in 30 to 50 healthy students with right dominant&#xD;
      hand, Their age will be ranged from 18 to 26 years old. Subjects will randomly assigned to&#xD;
      either proprioceptive neuromuscular facilitation (PNF) group or proprioceptive neuromuscular&#xD;
      facilitation with mental practice (PNFMP) group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PNF group: 15 - 25 individuals, these subjects will receive only PNF training. PNFMP: 15&#xD;
      individuals, these subjects will receive PNF training with MP. Training program will be&#xD;
      conducted for every group for 5 weeks with 3 sessions x 30 min per week. Electromyography&#xD;
      (EMG) device will be used to measure the electrical activity of muscles using surface&#xD;
      electrodes. Hydraulic hand dynamometer will be used to measure hand grip strength.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 16, 2018</start_date>
  <completion_date type="Actual">February 10, 2019</completion_date>
  <primary_completion_date type="Actual">February 3, 2019</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>There are two group of subjects: PNF group will receive only PNF training PNFMP group: will receive PNF training and mental pracice technique</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder joint strength</measure>
    <time_frame>6 minutes</time_frame>
    <description>electromyography device will be used to measure the electrical activity of the muscle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Elbow joint strength</measure>
    <time_frame>6 minutes</time_frame>
    <description>electromyography device will be used to measure the electrical activity of the muscle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength of hand grip</measure>
    <time_frame>15 minutes</time_frame>
    <description>Hand held dynamometer will be used to measure the strength of the hand grip</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Motor Activity</condition>
  <condition>Physical Activity</condition>
  <condition>Neuromuscu</condition>
  <arm_group>
    <arm_group_label>PNF group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>It will be consisted of 15 -25 healthy subjects receiving only proprioceptive nueromuscular facilitation training for 5 weeks with 17 days follow up after completion of program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PNFMP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It will be consisted of 15 -25 healthy subjects receiving proprioceptive nueromuscular facilitation training and mental practice technique for 5 weeks with 17 days follow up after completion of program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PNF</intervention_name>
    <description>proprioceptive neuromuscular facilitation training</description>
    <arm_group_label>PNF group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PNFMP</intervention_name>
    <description>proprioceptive neuromuscular facilitation training and mental practice technique</description>
    <arm_group_label>PNFMP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The participant will be right-handed.&#xD;
&#xD;
          2. Previously untrained subjects.&#xD;
&#xD;
          3. Absence of a prior injury of the hand or arm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of a neurological disease.&#xD;
&#xD;
          2. History of musculoskeletal injury of upper limb.&#xD;
&#xD;
          3. Unstable medical condition&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jazan University</name>
      <address>
        <city>Riyadh</city>
        <state>Jazan</state>
        <zip>45142</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>May 15, 2019</last_update_submitted>
  <last_update_submitted_qc>May 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jazan</investigator_affiliation>
    <investigator_full_name>Wafaa Mahmoud Amin</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>there is no plan</ipd_description>
  </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/NCT03767413
org study id: 8810025277
nct id: NCT03767413
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Influence of mental practice and proprioceptive neuromuscular facilitation on muscle strength
      of upper limb and hand grip will be measured in 30 to 50 healthy students with right dominant
      hand, Their age will be ranged from 18 to 26 years old. Subjects will randomly assigned to
      either proprioceptive neuromuscular facilitation (PNF) group or proprioceptive neuromuscular
      facilitation with mental practice (PNFMP) group.
PNF group: 15 - 25 individuals, these subjects will receive only PNF training. PNFMP: 15
      individuals, these subjects will receive PNF training with MP. Training program will be
      conducted for every group for 5 weeks with 3 sessions x 30 min per week. Electromyography
      (EMG) device will be used to measure the electrical activity of muscles using surface
      electrodes. Hydraulic hand dynamometer will be used to measure hand grip strength.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There are two group of subjects: PNF group will receive only PNF training PNFMP group: will receive PNF training and mental pracice technique
primary purpose: Health Services Research
masking: None (Open Label)
measure: Shoulder joint strength
time frame: 6 minutes
description: electromyography device will be used to measure the electrical activity of the muscle
measure: Elbow joint strength
time frame: 6 minutes
description: electromyography device will be used to measure the electrical activity of the muscle
measure: Strength of hand grip
time frame: 15 minutes
description: Hand held dynamometer will be used to measure the strength of the hand grip
arm group label: PNF group
arm group type: Active Comparator
description: It will be consisted of 15 -25 healthy subjects receiving only proprioceptive nueromuscular facilitation training for 5 weeks with 17 days follow up after completion of program.
arm group label: PNFMP
arm group type: Experimental
description: It will be consisted of 15 -25 healthy subjects receiving proprioceptive nueromuscular facilitation training and mental practice technique for 5 weeks with 17 days follow up after completion of program.
intervention type: Procedure
intervention name: PNF
description: proprioceptive neuromuscular facilitation training
arm group label: PNF group
intervention type: Procedure
intervention name: PNFMP
description: proprioceptive neuromuscular facilitation training and mental practice technique
arm group label: PNFMP
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: University of Jazan
investigator full name: Wafaa Mahmoud Amin
investigator title: Principal investigator
sharing ipd: No
ipd description: there is no plan