<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/NCT03759080</url>
  </required_header>
  <id_info>
    <org_study_id>2265749560</org_study_id>
    <nct_id>NCT03759080</nct_id>
  </id_info>
  <brief_title>Mental Practice Versus Proprioceptive Neuromuscular Facilitation on Strength of Upper Limb</brief_title>
  <official_title>Mental Practice Versus Proprioceptive Neuromuscular Facilitation on Strength of Upper Limb</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wafaa Mahmoud Amin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jazan</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The effects of mental practice combined with proprioceptive neuromuscular facilitation on&#xD;
      muscle strength of upper limb were measured in 60 healthy students Subjects were randomly&#xD;
      assigned to either proprioceptive neuromuscular facilitation (PNF) group or mental practice&#xD;
      (MP) group. PNF group: 30 individuals, these subjects received only PNF training. MP: 30&#xD;
      individuals, these subjects received mental practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effects of mental practice on muscle strength of upper limb were measured in 60 healthy&#xD;
      female students with right dominant hand,. Their age ranged from17 to 23 years old. Subjects&#xD;
      were randomly assigned to either proprioceptive neuromuscular facilitation (PNF) group or&#xD;
      mental practice (MP) group. PNF group: 30 individuals, these subjects received only PNF&#xD;
      training. MP: 30 individuals, these subjects received MP. training program has been&#xD;
      administered for every group for 12 sessions over 4 weeks with 3 x 45 min training sessions&#xD;
      per week. Pre-post test design was used. EMG device was used to measure the electrical&#xD;
      activity of muscles. Measurements conducted at pre-intervention, during intervention and&#xD;
      post-intervention testing with 20 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    due to sample problem&#xD;
  </why_stopped>
  <start_date type="Actual">May 8, 2018</start_date>
  <completion_date type="Anticipated">August 20, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 15, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>there are two arms :1. proprioceptive neuromuscular facilitation (PNF) group ,2 mental practice (MP) group.&#xD;
PNF group: 30 individuals, these subjects received PNF training. PNFMP: 30 individuals, these subjects receivedMP. training program has been administered for every group for 12 sessions over 4 weeks with 3 x 45 min training sessions per week.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Strength Evaluation of coracobrachialis Muscle</measure>
    <time_frame>2 minutes.</time_frame>
    <description>Electromyography device was used to measure the electrical activity of muscle.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength Evaluation of teres minor muscle</measure>
    <time_frame>2 minutes.</time_frame>
    <description>Electromyography device was used to measure the electrical activity of muscle.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength Evaluation of Brachialis muscle</measure>
    <time_frame>2 minutes.</time_frame>
    <description>Electromyography device was used to measure the electrical activity of muscle.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Motor Activity</condition>
  <arm_group>
    <arm_group_label>intervention of PNF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PNF group: 30 individuals, these subjects received proprioceptive neuromuscular facilitation training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PNFMP group:30 individuals, these subjects received mental practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>mental practice</intervention_name>
    <description>training of mental practice to do the pattern of proprioceptive neuromuscular facilitation</description>
    <arm_group_label>MP</arm_group_label>
    <other_name>MP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>proprioceptive neuromuscular facilitation</intervention_name>
    <description>upper limb Pattern: Flexion -Abduction- External rotation</description>
    <arm_group_label>intervention of PNF</arm_group_label>
    <other_name>PNF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.Absence of a prior injury of arm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1.History of a neurological disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>23 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>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 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>Sponsor-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 made</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/NCT03759080
org study id: 2265749560
nct id: NCT03759080
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The effects of mental practice combined with proprioceptive neuromuscular facilitation on
      muscle strength of upper limb were measured in 60 healthy students Subjects were randomly
      assigned to either proprioceptive neuromuscular facilitation (PNF) group or mental practice
      (MP) group. PNF group: 30 individuals, these subjects received only PNF training. MP: 30
      individuals, these subjects received mental practice.
The effects of mental practice on muscle strength of upper limb were measured in 60 healthy
      female students with right dominant hand,. Their age ranged from17 to 23 years old. Subjects
      were randomly assigned to either proprioceptive neuromuscular facilitation (PNF) group or
      mental practice (MP) group. PNF group: 30 individuals, these subjects received only PNF
      training. MP: 30 individuals, these subjects received MP. training program has been
      administered for every group for 12 sessions over 4 weeks with 3 x 45 min training sessions
      per week. Pre-post test design was used. EMG device was used to measure the electrical
      activity of muscles. Measurements conducted at pre-intervention, during intervention and
      post-intervention testing with 20 days.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: there are two arms :1. proprioceptive neuromuscular facilitation (PNF) group ,2 mental practice (MP) group.
PNF group: 30 individuals, these subjects received PNF training. PNFMP: 30 individuals, these subjects receivedMP. training program has been administered for every group for 12 sessions over 4 weeks with 3 x 45 min training sessions per week.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Strength Evaluation of coracobrachialis Muscle
time frame: 2 minutes.
description: Electromyography device was used to measure the electrical activity of muscle.
measure: Strength Evaluation of teres minor muscle
time frame: 2 minutes.
description: Electromyography device was used to measure the electrical activity of muscle.
measure: Strength Evaluation of Brachialis muscle
time frame: 2 minutes.
description: Electromyography device was used to measure the electrical activity of muscle.
arm group label: intervention of PNF
arm group type: Active Comparator
description: PNF group: 30 individuals, these subjects received proprioceptive neuromuscular facilitation training.
arm group label: MP
arm group type: Experimental
description: PNFMP group:30 individuals, these subjects received mental practice.
intervention type: Procedure
intervention name: mental practice
description: training of mental practice to do the pattern of proprioceptive neuromuscular facilitation
arm group label: MP
other name: MP
intervention type: Procedure
intervention name: proprioceptive neuromuscular facilitation
description: upper limb Pattern: Flexion -Abduction- External rotation
arm group label: intervention of PNF
other name: PNF
criteria: 
gender: Female
minimum age: 17 Years
maximum age: 23 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Saudi Arabia
responsible party type: Sponsor-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 made