<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/NCT04487821</url>
  </required_header>
  <id_info>
    <org_study_id>ZIHS-1205/MS/12</org_study_id>
    <nct_id>NCT04487821</nct_id>
  </id_info>
  <brief_title>EFFECTS OF VESTIBULAR REHABILITATION THERAPY (VRT) ON BALANCE, SPEED AND AGILITY IN POST-CONCUSSION FOOTBALL PLAYERS</brief_title>
  <official_title>EFFECTS OF VESTIBULAR REHABILITATION THERAPY (VRT) ON BALANCE, SPEED AND AGILITY IN POST-CONCUSSION FOOTBALL PLAYERS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zohra Institute of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zohra Institute of Health Sciences</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>
      Traumatic brain injury (TBI) is one and utmost rampant attained neurological conditions which&#xD;
      can happen in young adults. Vestibular Rehabilitation Therapy can help them improve their&#xD;
      balance, speed and agility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total 40 sample size out of which were divided into control and experimental group. Concussed&#xD;
      football athletes with age ranging 15-25 year, those participating actively in the sports&#xD;
      were included in the study in the region of Kyber Pukhtoonkhwa Peshawar.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>upto 8 weeks</time_frame>
    <description>Balance Error Scoring System (BESS) which us used to evaluate the balance of the athlete</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agility</measure>
    <time_frame>upto 8 weeks</time_frame>
    <description>30 Ft Agility Shuttle Run which is used to evaluate agility of athletes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speed</measure>
    <time_frame>upto 8 weeks</time_frame>
    <description>30 Meter dash which is used to evaluate the speed of the athlete</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Concussion, Mild</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment. This contained 4 types of progressive activities. Respectively every type contains 2 to 4 tasks, performed in sets of 10 repetitions for 4 weeks.&#xD;
Results were obtained by using Balance scoring system, and physical performance test for speed and agility</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group: (Group B) Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment. They were asked to perform the regular drills.&#xD;
Results were obtained using Balance Error scoring system and physical performance test for speed and agility.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cawthorne Cooksey Exercises</intervention_name>
    <description>Activity sitting on the &quot;Exercise Ball&quot; swing (eye movements, first slow and then fast)&#xD;
Swing sitting activity (head movements, first slow then fast - eyes open and eyes closed)&#xD;
Trunk activities focusing on balance&#xD;
Dynamic balance activity focusing on standing</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Active Male football player. Age between 15-25 years. Known cases of concussion were&#xD;
        included in the study. Those patients complaining mild vertigo &amp; participating in sports&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Concussion other than sports. History of metabolic diseases. History of recent fractures.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Syed Alamdar Hussain</name>
      <address>
        <city>Peshawar</city>
        <state>KP</state>
        <zip>25000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zohra Institute of Health Sciences</investigator_affiliation>
    <investigator_full_name>Syed Alamdar Hussain</investigator_full_name>
    <investigator_title>Syed Alamdar Hussain</investigator_title>
  </responsible_party>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Concussion</keyword>
  <keyword>Vestibular Rehabilitation Therapy</keyword>
  <keyword>Football</keyword>
  <keyword>Balance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Concussion</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/NCT04487821
org study id: ZIHS-1205/MS/12
nct id: NCT04487821
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Traumatic brain injury (TBI) is one and utmost rampant attained neurological conditions which
      can happen in young adults. Vestibular Rehabilitation Therapy can help them improve their
      balance, speed and agility.
Total 40 sample size out of which were divided into control and experimental group. Concussed
      football athletes with age ranging 15-25 year, those participating actively in the sports
      were included in the study in the region of Kyber Pukhtoonkhwa Peshawar.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Balance
time frame: upto 8 weeks
description: Balance Error Scoring System (BESS) which us used to evaluate the balance of the athlete
measure: Agility
time frame: upto 8 weeks
description: 30 Ft Agility Shuttle Run which is used to evaluate agility of athletes
measure: Speed
time frame: upto 8 weeks
description: 30 Meter dash which is used to evaluate the speed of the athlete
arm group label: Experimental Group
arm group type: Experimental
description: Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment. This contained 4 types of progressive activities. Respectively every type contains 2 to 4 tasks, performed in sets of 10 repetitions for 4 weeks.
Results were obtained by using Balance scoring system, and physical performance test for speed and agility
arm group label: Control Group
arm group type: No Intervention
description: Control group: (Group B) Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment. They were asked to perform the regular drills.
Results were obtained using Balance Error scoring system and physical performance test for speed and agility.
intervention type: Other
intervention name: Cawthorne Cooksey Exercises
description: Activity sitting on the "Exercise Ball" swing (eye movements, first slow and then fast)
Swing sitting activity (head movements, first slow then fast - eyes open and eyes closed)
Trunk activities focusing on balance
Dynamic balance activity focusing on standing
arm group label: Experimental Group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: No
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Zohra Institute of Health Sciences
investigator full name: Syed Alamdar Hussain
investigator title: Syed Alamdar Hussain
mesh term: Brain Concussion