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/NCT05976880</url>
    </required_header>
    <id_info>
      <org_study_id>REC/RCR&amp;AHS/23/0708</org_study_id>
      <nct_id>NCT05976880</nct_id>
    </id_info>
    <brief_title>Grip Effects of Power Ball in Children</brief_title>
    <official_title>Grip Effects of Power Ball in Children With Visual Impairment</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>
      <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>
        A broad definition of visual impairment includes a wide continuum of visual function loss.&#xD;
        Aspects of visual function include visual acuity, which is the capacity to resolve detail,&#xD;
        and accommodation (capacity to concentrate), field of vision (the area that may be seen),&#xD;
        colour perception, and light sensitivity. A child with cerebral blindness can nevertheless be&#xD;
        able to perceive motion. There are numerous sources of prevalence information, each of which&#xD;
        has drawbacks. One of the fundamental pillars of the major worldwide prevention of blindness&#xD;
        project, VISION 2020 the Right to Sight, is the reduction of visual impairment and blindness&#xD;
        in children in resource-poor nations. Refraction and poor vision services aid visually&#xD;
        impaired children, especially those with genetic or congenital ocular defects and enable&#xD;
        vision improvement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Visual impairment is a broad term that describes a wide continuum of loss in visual function.&#xD;
        There are many aspects of visual function e.g., visual acuity(ability to resolve&#xD;
        detail),accommodation (ability to focus), field of vision (area which can be seen), colour&#xD;
        vision and adapt ability to light. A child with cerebral blindness may have intact perception&#xD;
        of movement. Prevalence data can be obtained from a variety of different sources, each of&#xD;
        which has limitations. Reducing visual impairment and blindness in children in resource-poor&#xD;
        countries is one of the key components of the major global prevention of blindness&#xD;
        initiative, VISION 2020 the Right to Sight. Visually impaired children especially with&#xD;
        hereditary /congenital ocular anomalies benefit from refraction and low vision services which&#xD;
        facilitate vision enhancement and inclusive education. Pediatricians have a key role in early&#xD;
        detection and multidisciplinary management to minimise the impact of visual impairment (VI)&#xD;
        in childhood.Visually impaired children especially with hereditary /congenital ocular&#xD;
        anomalies benefit from refraction and low vision services which facilitate vision enhancement&#xD;
        and inclusive Powerball® is such a market existing device that can be used for wrist&#xD;
        rehabilitation and also as a sports aid for strengthening the wrist. The Powerball acts as an&#xD;
        eccentric exercise tool, generating forces in different directions and thus causing&#xD;
        stimulation of the forearm, hand, and wrist musculature. The tools used will be handheld&#xD;
        dynamometer and pegboard test. Study will be conducted on Twenty eight patients in two&#xD;
        Groups. .Group A will be Control Group that will be provided with conventional physiotherapy&#xD;
        (isometric hand grip training exercises) and Group B will be Experimental Group that&#xD;
        Conventional treatment with power ball training. Data will be analyzed using spss 22.0&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 15, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>
      <intervention_model_description>Its a randomized control trial,used to measure the grip strength of visually impared children by powerball.Subjects with visual impairment meeting the predetermined inclusion and exclusion criteria will be divided into two groups using random sampling technique</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants will get separate tretment protocols and possible efforts will be put to mask the both groups about their treatment</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Grip strength</measure>
      <time_frame>4 weeks</time_frame>
      <description>grip strength will be meaured by dynamometer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>nine-hole peg test</measure>
      <time_frame>4 weeks</time_frame>
      <description>nine-hole peg test will be utilized to measure grip performance..</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Visual Impairment</condition>
    <arm_group>
      <arm_group_label>Conventional treatment of isometric hand grip training exercises</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In control group, conventional treatment perform by using isometric hand grip training exercises (putty grip and squeeze exercise, thumb pinch z strengthening exercises, isometric Hooks exercises, rubber band abduction and c thumb exercises) for 3times a week in one month.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional treatment along with power ball training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In experimental group, 3sessions per week and total 12 training sessions in a month will be perform. In this session, conventional treatment perform with power ball exercise should be done for 3 minutes in a day, where power ball can initially alleviate the pain, then make them feel strong and in the end persons feel strengthen with pain free movements. Before start training with a power ball, hand held dynamometer will use prior to the first session, on 7th session of training and after 12th training session. So that changes in hand grip strength can be measured by dynamometer.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional treatment of isometric hand grip training exercises</intervention_name>
      <description>In control group, conventional treatment perform by using isometric hand grip training exercises (putty grip and squeeze exercise, thumb pinch z strengthening exercises, isometric Hooks exercises, rubber band abduction and c thumb exercises) for 3times a week in one month.</description>
      <arm_group_label>Conventional treatment of isometric hand grip training exercises</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional treatment along with power ball training</intervention_name>
      <description>In experimental group, 3sessions per week and total 12 training sessions in a month will be perform. In this session, conventional treatment perform with power ball exercise should be done for 3 minutes in a day, where power ball can initially alleviate the pain, then make them feel strong and in the end persons feel strengthen with pain free movements. Before start training with a power ball, hand held dynamometer will use prior to the first session, on 7th session of training and after 12th training session. So that changes in hand grip strength can be measured by dynamometer.</description>
      <arm_group_label>Conventional treatment along with power ball training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ranging from 8 to 14 years,&#xD;
  &#xD;
            -  Both genders (male /female)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Serious medical conditions such as cardiac disease, diabetes, or uncontrolled seizures&#xD;
  &#xD;
            -  Significant shoulder, elbow, or&#xD;
  &#xD;
            -  wrist joint contractures preventing grip movement of the hand and fingers.&#xD;
  &#xD;
            -  Unable to follow the command&#xD;
  &#xD;
            -  Orthopedic surgery, neurological surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahsan Taqweem, DPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Imran Amjad, PhD</last_name>
      <phone>+9233224390125</phone>
      <email>imran.amjad@riphah.edu.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Muhammad Asif Javed, MS</last_name>
      <phone>+923224209422</phone>
      <email>a.javaid@riphah.edu.pk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rising Sun Institute for Special Children</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>54000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Rasool J, Akram S, Jamil A, Tauseef M, Ilyas A. Effects of Power Ball Exercises in Addition to Routine Physical Therapy on Pain, Grip Strength and Functional Disability in Patients with Carpal Tunnel Syndrome: Power Ball Exercises in Carpal Tunnel Syndrome. The Healer Journal of Physiotherapy and Rehabilitation Sciences. 2023 May 3;3(4):451-60.</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vision Disorders</mesh_term>
      <mesh_term>Vision, Low</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/NCT05976880
  org study id: REC/RCR&AHS/23/0708
  nct id: NCT05976880
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A broad definition of visual impairment includes a wide continuum of visual function loss.
        Aspects of visual function include visual acuity, which is the capacity to resolve detail,
        and accommodation (capacity to concentrate), field of vision (the area that may be seen),
        colour perception, and light sensitivity. A child with cerebral blindness can nevertheless be
        able to perceive motion. There are numerous sources of prevalence information, each of which
        has drawbacks. One of the fundamental pillars of the major worldwide prevention of blindness
        project, VISION 2020 the Right to Sight, is the reduction of visual impairment and blindness
        in children in resource-poor nations. Refraction and poor vision services aid visually
        impaired children, especially those with genetic or congenital ocular defects and enable
        vision improvement.
  Visual impairment is a broad term that describes a wide continuum of loss in visual function.
        There are many aspects of visual function e.g., visual acuity(ability to resolve
        detail),accommodation (ability to focus), field of vision (area which can be seen), colour
        vision and adapt ability to light. A child with cerebral blindness may have intact perception
        of movement. Prevalence data can be obtained from a variety of different sources, each of
        which has limitations. Reducing visual impairment and blindness in children in resource-poor
        countries is one of the key components of the major global prevention of blindness
        initiative, VISION 2020 the Right to Sight. Visually impaired children especially with
        hereditary /congenital ocular anomalies benefit from refraction and low vision services which
        facilitate vision enhancement and inclusive education. Pediatricians have a key role in early
        detection and multidisciplinary management to minimise the impact of visual impairment (VI)
        in childhood.Visually impaired children especially with hereditary /congenital ocular
        anomalies benefit from refraction and low vision services which facilitate vision enhancement
        and inclusive Powerball® is such a market existing device that can be used for wrist
        rehabilitation and also as a sports aid for strengthening the wrist. The Powerball acts as an
        eccentric exercise tool, generating forces in different directions and thus causing
        stimulation of the forearm, hand, and wrist musculature. The tools used will be handheld
        dynamometer and pegboard test. Study will be conducted on Twenty eight patients in two
        Groups. .Group A will be Control Group that will be provided with conventional physiotherapy
        (isometric hand grip training exercises) and Group B will be Experimental Group that
        Conventional treatment with power ball training. Data will be analyzed using spss 22.0
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Its a randomized control trial,used to measure the grip strength of visually impared children by powerball.Subjects with visual impairment meeting the predetermined inclusion and exclusion criteria will be divided into two groups using random sampling technique
  primary purpose: Other
  masking: Single (Participant)
  masking description: Participants will get separate tretment protocols and possible efforts will be put to mask the both groups about their treatment
  measure: Grip strength
  time frame: 4 weeks
  description: grip strength will be meaured by dynamometer
  measure: nine-hole peg test
  time frame: 4 weeks
  description: nine-hole peg test will be utilized to measure grip performance..
  arm group label: Conventional treatment of isometric hand grip training exercises
  arm group type: Active Comparator
  description: In control group, conventional treatment perform by using isometric hand grip training exercises (putty grip and squeeze exercise, thumb pinch z strengthening exercises, isometric Hooks exercises, rubber band abduction and c thumb exercises) for 3times a week in one month.
  arm group label: Conventional treatment along with power ball training
  arm group type: Experimental
  description: In experimental group, 3sessions per week and total 12 training sessions in a month will be perform. In this session, conventional treatment perform with power ball exercise should be done for 3 minutes in a day, where power ball can initially alleviate the pain, then make them feel strong and in the end persons feel strengthen with pain free movements. Before start training with a power ball, hand held dynamometer will use prior to the first session, on 7th session of training and after 12th training session. So that changes in hand grip strength can be measured by dynamometer.
  intervention type: Other
  intervention name: Conventional treatment of isometric hand grip training exercises
  description: In control group, conventional treatment perform by using isometric hand grip training exercises (putty grip and squeeze exercise, thumb pinch z strengthening exercises, isometric Hooks exercises, rubber band abduction and c thumb exercises) for 3times a week in one month.
  arm group label: Conventional treatment of isometric hand grip training exercises
  intervention type: Other
  intervention name: Conventional treatment along with power ball training
  description: In experimental group, 3sessions per week and total 12 training sessions in a month will be perform. In this session, conventional treatment perform with power ball exercise should be done for 3 minutes in a day, where power ball can initially alleviate the pain, then make them feel strong and in the end persons feel strengthen with pain free movements. Before start training with a power ball, hand held dynamometer will use prior to the first session, on 7th session of training and after 12th training session. So that changes in hand grip strength can be measured by dynamometer.
  arm group label: Conventional treatment along with power ball training
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 14 Years
  healthy volunteers: No
  last name: Ahsan Taqweem, DPT
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Imran Amjad, PhD
  phone: +9233224390125
  email: imran.amjad@riphah.edu.pk
  last name: Muhammad Asif Javed, MS
  phone: +923224209422
  email: a.javaid@riphah.edu.pk
  facility: 
  status: Recruiting
  country: Pakistan
  citation: Rasool J, Akram S, Jamil A, Tauseef M, Ilyas A. Effects of Power Ball Exercises in Addition to Routine Physical Therapy on Pain, Grip Strength and Functional Disability in Patients with Carpal Tunnel Syndrome: Power Ball Exercises in Carpal Tunnel Syndrome. The Healer Journal of Physiotherapy and Rehabilitation Sciences. 2023 May 3;3(4):451-60.
  responsible party type: Sponsor
  mesh term: Vision Disorders
  mesh term: Vision, Low
  sharing ipd: No