xml: <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/NCT06001983</url>
    </required_header>
    <id_info>
      <org_study_id>REC/RCR &amp; AHS/23/0721</org_study_id>
      <nct_id>NCT06001983</nct_id>
    </id_info>
    <brief_title>Effect of Imaginary Resisted Therapy Versus Physical Resisted Therapy on Hemiplegic Cerebral Palsy</brief_title>
    <official_title>Effects of Imaginary Resisted Exercises Versus Physical Resisted Exercises on Hand Grip Strength in Children With Hemiplegic Cerebral Palsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</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>
        The purpose of this study is to compare the effects of imaginary resisted exercises versus&#xD;
        physical resisted exercises on hand grip strength in hemiplegic cerebral palsy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cerebral palsy (CP) is one of the most frequent causes of motor disability in children. CP is&#xD;
        a group of permanent disorders of the development of movement and posture, causing activity&#xD;
        limitations that are attributed to non-progressive disturbances that occurred in the&#xD;
        developing fetal or infant brain. The risk factors for CP can be divided into pre-conception,&#xD;
        prenatal, perinatal and postnatal ones. Twenty five percent of children with CP have spastic&#xD;
        hemiplegia. Hemiplegic cerebral palsy falls in anatomic classification of cerebral palsy&#xD;
        which affects only one side of body. Children who have hemiplegic cerebral palsy have&#xD;
        absolutely no use of one side of the body. This means their shoulder; arm, hand, leg and foot&#xD;
        are all completely paralyzed. So, in order to improve strength in upper extremity and hand,&#xD;
        resistance exercises are used.&#xD;
  &#xD;
        The study will be a randomized control trial. Patients will be recruited into two groups&#xD;
        using simple random assignment. Non probability convenient sampling will be used. Data will&#xD;
        be collected from patients with hemiplegic cerebral palsy by using Jamar dynamometer which is&#xD;
        consider as a gold standard in measuring repetitive gripping, goniometer for range of motion&#xD;
        and Finger to nose test to access the upper extremity function in stroke patient Those who&#xD;
        will meet the inclusion criteria will be recruited. Group A will receive imaginary resisted&#xD;
        exercise therapy Five types of different resistances will be imagined by patients by watching&#xD;
        their own videos in VR box, which will be recorded on day one to make them familiar with the&#xD;
        resistive objects and the resistance experienced from them by asking patients to perform&#xD;
        15-15 repetitions of each object. Group B will receive physical resisted exercise therapy in&#xD;
        which 5 different types of resistances will be given to patients for making themselves&#xD;
        familiarize themselves with the type of resistance applied by each object, that they will&#xD;
        experience in further sessions, by asking them to perform 15-15 repetitions of each object.&#xD;
        Every physical resistance exercise will have 15 repetitions. At the end of each session&#xD;
        patient will perform finger to nose test and Purdue peg board test. After collecting data&#xD;
        from the defined setting, it will be entered and analyzed using statistical package for&#xD;
        social sciences (SPSS) for Windows Software, version 21.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 30, 2023</start_date>
    <completion_date type="Anticipated">September 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Jamar Dynamometer (Hydraulic Hand Dynameter)</measure>
      <time_frame>4 weeks</time_frame>
      <description>The Jamar is the primary outcome measure for assessing hand grip strength</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Finger to Nose Test</measure>
      <time_frame>4 weeks</time_frame>
      <description>It is a part of the Fugl-Meyer Assessment for upper extremity to evaluate impairment of upper limb in stroke patients. The total movement time is used as a clinical outcome measure for quantification of movement quality and motor performance. Most commonly the person is seated and upon command moves the index fingertip back and forth between the ipsilateral knee and the tip of the nose five times, as fast, as accurate, as possible</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Purdue Peg Board Test</measure>
      <time_frame>4 weeks</time_frame>
      <description>It is a functional assessment tool to screen for hand dexterity. It was designed to assess fine motor hand function using three common objects, pegs, washers, and collars, to be inserted on&#xD;
  a pegboard. With its long history and wide usage, its reliability in healthy subjects is well established because it employs tasks that resemble activities of daily living. It is economical and easy to administer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Goniometer</measure>
      <time_frame>4 weeks</time_frame>
      <description>Goniometer has been the most widely used tool for measuring joint range of motion. To ensure reliable measurement, standardized, specific positions and landmarks are used to measure each joint movement</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cell Phone Camera</measure>
      <time_frame>4 weeks</time_frame>
      <description>Redmi Note 7 with front camera 13 MP or above and Rear camera 48 MP or above</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Hemiplegic Cerebral Palsy</condition>
    <arm_group>
      <arm_group_label>Imaginary resisted exercises</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>• Handgrip exercises with the imagination of resistance in hand by getting feedback in VR Box will be given as an intervention. Stretching will be given at the beginning and the end of each session. This will include imaginary resistance exercises for handgrip by using Virtual Reality Box. Five types of different resistances will be imagined by patients by watching their own videos in VR box, which will be recorded on day one to make them familiar with the resistive objects and the resistance experienced from them by asking patients to perform 15-15 repetitions of each object. Every imaginary resistance exercise will have 15 repetitions. After performing exercises, the participants will ask to perform Finger-to-Nose Test and Purdue Pegboard Test.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Physical resisted exercises</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Handgrip exercises with physical resistance in hand will be given as an intervention. Stretching will be given at the beginning and the end of the session. 5 different types of resistances will be given to patients for making themselves familiarize themselves with the type of resistance applied by each object, that they will experience in further sessions, by asking them to perform 15-15 repetitions of each object. Every physical resistance exercise will have 15 repetitions. After performing exercises, the participants will ask to perform Finger-to-Nose Test and Purdue Pegboard Test. In physical resistance exercises, resistive force is applied to the targeted region by using different and appropriate resistive objects</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>imaginary resisted exercises</intervention_name>
      <description>Imagination of squeezing a Sponge ball 15 reps&#xD;
  Imagination of Finger Exerciser 15 reps&#xD;
  Imagination of Theraband 15 reps&#xD;
  Imagination of pressing Rubber ball 15 reps&#xD;
  Imagination of pressing Hard object 15 reps</description>
      <arm_group_label>Imaginary resisted exercises</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>physical resisted exercises</intervention_name>
      <description>Resisted exercise of Squeezing a Sponge ball 15 reps&#xD;
  Resisted exercise of Finger Exerciser 15 reps&#xD;
  Resisted exercise of pulling theraband 15 reps&#xD;
  Resisted exercise of pressing Rubber ball 15 reps&#xD;
  Resisted exercise of pressing Hard object 15 reps</description>
      <arm_group_label>Physical resisted exercises</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Congenital infantile hemiplegia.&#xD;
  &#xD;
            -  Aged between 6 and 12 years.&#xD;
  &#xD;
            -  Lack of use of the affected upper limb.&#xD;
  &#xD;
            -  Level I-III of the Manual Ability Classification System (MACS).&#xD;
  &#xD;
            -  Students scoring of Modified Ashworth Scale should be 3 or less than 3 out of 5 for&#xD;
               the same muscle groups of previously mentioned movements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Low cognitive level compatible with attending a special education school.&#xD;
  &#xD;
            -  Presence of contractures in the affected upper limb affecting the functional movement.&#xD;
  &#xD;
            -  Surgery in the six months previously to the treatment.&#xD;
  &#xD;
            -  Botulinum toxin in the two months previously to or during the intervention.&#xD;
  &#xD;
            -  Pharmacologically uncontrolled epilepsy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dr. Nosheen Manzoor, MS OMPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dr. Nosheen Manzoor, MS OMPT</last_name>
      <phone>03236877879</phone>
      <email>Nosheenmanzoor_444@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Govt. National special education centre</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>54782</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Naseer Khan</last_name>
        <phone>03076913927</phone>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hemiplegic Cerebral Palsy, Hand Grip Strength, Imaginary Resisted Exercises, Physical Resisted Exercises.</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paralysis</mesh_term>
      <mesh_term>Cerebral Palsy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001983
  org study id: REC/RCR & AHS/23/0721
  nct id: NCT06001983
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to compare the effects of imaginary resisted exercises versus
        physical resisted exercises on hand grip strength in hemiplegic cerebral palsy
  Cerebral palsy (CP) is one of the most frequent causes of motor disability in children. CP is
        a group of permanent disorders of the development of movement and posture, causing activity
        limitations that are attributed to non-progressive disturbances that occurred in the
        developing fetal or infant brain. The risk factors for CP can be divided into pre-conception,
        prenatal, perinatal and postnatal ones. Twenty five percent of children with CP have spastic
        hemiplegia. Hemiplegic cerebral palsy falls in anatomic classification of cerebral palsy
        which affects only one side of body. Children who have hemiplegic cerebral palsy have
        absolutely no use of one side of the body. This means their shoulder; arm, hand, leg and foot
        are all completely paralyzed. So, in order to improve strength in upper extremity and hand,
        resistance exercises are used.
  
        The study will be a randomized control trial. Patients will be recruited into two groups
        using simple random assignment. Non probability convenient sampling will be used. Data will
        be collected from patients with hemiplegic cerebral palsy by using Jamar dynamometer which is
        consider as a gold standard in measuring repetitive gripping, goniometer for range of motion
        and Finger to nose test to access the upper extremity function in stroke patient Those who
        will meet the inclusion criteria will be recruited. Group A will receive imaginary resisted
        exercise therapy Five types of different resistances will be imagined by patients by watching
        their own videos in VR box, which will be recorded on day one to make them familiar with the
        resistive objects and the resistance experienced from them by asking patients to perform
        15-15 repetitions of each object. Group B will receive physical resisted exercise therapy in
        which 5 different types of resistances will be given to patients for making themselves
        familiarize themselves with the type of resistance applied by each object, that they will
        experience in further sessions, by asking them to perform 15-15 repetitions of each object.
        Every physical resistance exercise will have 15 repetitions. At the end of each session
        patient will perform finger to nose test and Purdue peg board test. After collecting data
        from the defined setting, it will be entered and analyzed using statistical package for
        social sciences (SPSS) for Windows Software, version 21.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Jamar Dynamometer (Hydraulic Hand Dynameter)
  time frame: 4 weeks
  description: The Jamar is the primary outcome measure for assessing hand grip strength
  measure: Finger to Nose Test
  time frame: 4 weeks
  description: It is a part of the Fugl-Meyer Assessment for upper extremity to evaluate impairment of upper limb in stroke patients. The total movement time is used as a clinical outcome measure for quantification of movement quality and motor performance. Most commonly the person is seated and upon command moves the index fingertip back and forth between the ipsilateral knee and the tip of the nose five times, as fast, as accurate, as possible
  measure: Purdue Peg Board Test
  time frame: 4 weeks
  description: It is a functional assessment tool to screen for hand dexterity. It was designed to assess fine motor hand function using three common objects, pegs, washers, and collars, to be inserted on
  a pegboard. With its long history and wide usage, its reliability in healthy subjects is well established because it employs tasks that resemble activities of daily living. It is economical and easy to administer
  measure: Goniometer
  time frame: 4 weeks
  description: Goniometer has been the most widely used tool for measuring joint range of motion. To ensure reliable measurement, standardized, specific positions and landmarks are used to measure each joint movement
  measure: Cell Phone Camera
  time frame: 4 weeks
  description: Redmi Note 7 with front camera 13 MP or above and Rear camera 48 MP or above
  arm group label: Imaginary resisted exercises
  arm group type: Experimental
  description: • Handgrip exercises with the imagination of resistance in hand by getting feedback in VR Box will be given as an intervention. Stretching will be given at the beginning and the end of each session. This will include imaginary resistance exercises for handgrip by using Virtual Reality Box. Five types of different resistances will be imagined by patients by watching their own videos in VR box, which will be recorded on day one to make them familiar with the resistive objects and the resistance experienced from them by asking patients to perform 15-15 repetitions of each object. Every imaginary resistance exercise will have 15 repetitions. After performing exercises, the participants will ask to perform Finger-to-Nose Test and Purdue Pegboard Test.
  arm group label: Physical resisted exercises
  arm group type: Experimental
  description: Handgrip exercises with physical resistance in hand will be given as an intervention. Stretching will be given at the beginning and the end of the session. 5 different types of resistances will be given to patients for making themselves familiarize themselves with the type of resistance applied by each object, that they will experience in further sessions, by asking them to perform 15-15 repetitions of each object. Every physical resistance exercise will have 15 repetitions. After performing exercises, the participants will ask to perform Finger-to-Nose Test and Purdue Pegboard Test. In physical resistance exercises, resistive force is applied to the targeted region by using different and appropriate resistive objects
  intervention type: Other
  intervention name: imaginary resisted exercises
  description: Imagination of squeezing a Sponge ball 15 reps
  Imagination of Finger Exerciser 15 reps
  Imagination of Theraband 15 reps
  Imagination of pressing Rubber ball 15 reps
  Imagination of pressing Hard object 15 reps
  arm group label: Imaginary resisted exercises
  intervention type: Other
  intervention name: physical resisted exercises
  description: Resisted exercise of Squeezing a Sponge ball 15 reps
  Resisted exercise of Finger Exerciser 15 reps
  Resisted exercise of pulling theraband 15 reps
  Resisted exercise of pressing Rubber ball 15 reps
  Resisted exercise of pressing Hard object 15 reps
  arm group label: Physical resisted exercises
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Dr. Nosheen Manzoor, MS OMPT
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Dr. Nosheen Manzoor, MS OMPT
  phone: 03236877879
  email: Nosheenmanzoor_444@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Paralysis
  mesh term: Cerebral Palsy
  sharing ipd: No