<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/NCT02978469</url>
  </required_header>
  <id_info>
    <org_study_id>0082-15-ASF</org_study_id>
    <nct_id>NCT02978469</nct_id>
  </id_info>
  <brief_title>Go For It: to Improve Levels of Daily Physical Activity and to Reduce the Sedentary Life Style of Adolescents With CP</brief_title>
  <official_title>Promoting Active Healthy Lifestyle of Adolescents With Brain Damage Due to Traumatic Brain Injury and Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assaf-Harofeh Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assaf-Harofeh Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Long hours of daily sitting and lack of Physical Activity (PA) are risk factors for morbidity&#xD;
      and mortality.&#xD;
&#xD;
      People with movement disabilities, including adolescents with Cerebral Palsy (CP) tend to&#xD;
      lead a sedentary life styl and have have poor physical fitness. Adolescents with CP where&#xD;
      found to be inactive most of the day thus, they are in greater risk of disease than the&#xD;
      general population. In addition, over the years, people with disabilities experience physical&#xD;
      and functional deterioration. Reducing sedentary behavior and increasing daily activity can&#xD;
      reduce health risk factors among the adolescents with CP, reduce secondary impairments and&#xD;
      preserve function.&#xD;
&#xD;
      Interventions that included exercise alone has not resulted in physical activity and&#xD;
      participating in a structured training did not continue after cessation intervention.&#xD;
&#xD;
      The objectives of this study are to establish effective programs aiming to promote an active&#xD;
      life style among adolescents and young adults with CP and to evaluate there outcomes.&#xD;
&#xD;
      Specific objectives- Stage 1- Identifying barriers and facilitators for reducing sedentary&#xD;
      behaviors and increasing physical activity among adolescents and young adults with CP. As&#xD;
      well as, identifying mediators, needs and preferences for reducing sedentary behaviors and&#xD;
      increasing physical activity among adolescents and young adults with CP.&#xD;
&#xD;
      Stage 2- Based on stage 1- Establishing an intervention for reducing sedentary behaviors and&#xD;
      increasing physical activity among adolescents.&#xD;
&#xD;
      Stage 3- translating and developing questioners for the study.&#xD;
&#xD;
        -  Translating the ASK-Performance and the ASK-Capability questionnaires to Hebrew and&#xD;
           validating the Hebrew translation.&#xD;
&#xD;
        -  Developing a self-efficacy perception questioner for increasing physical activity and&#xD;
           reducing and sedentary behavior.&#xD;
&#xD;
        -  Translating to Hebrew, adjusting and validating an activity diary.&#xD;
&#xD;
      Stage 4- evaluating the effectiveness of the proposed intervention program on reducing&#xD;
      sedentary behaviors and increasing physical activity among adolescents and young adults with&#xD;
      CP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stage 1 focus group- Identifying barriers and facilitators for reducing sedentary behaviors&#xD;
      and increasing physical activity as well as, identifying mediators, needs and preferences for&#xD;
      reducing sedentary behaviors and increasing physical activity.&#xD;
&#xD;
      Stage 2- Based on stage 1- Establishing an intervention for reducing sedentary behaviors and&#xD;
      increasing physical activity among adolescents. The intervention group will receive&#xD;
      behavior-modification in group. The control group will get physical exercises.Stage 3-&#xD;
      translating and developing questioners for the study.&#xD;
&#xD;
        -  Translating the ASK-Performance and the ASK-Capability questionnaires to Hebrew and&#xD;
           validating the Hebrew translation.&#xD;
&#xD;
        -  Developing a self-efficacy perception questioner for increasing physical activity and&#xD;
           reducing and sedentary behavior.&#xD;
&#xD;
        -  Translating to Hebrew, adjusting and validating an activity diary.&#xD;
&#xD;
      Stage 4- evaluating the effectiveness of the proposed intervention program on reducing&#xD;
      sedentary behaviors and increasing physical activity among adolescents and young adults with&#xD;
      CP. The outcome measures will measure change from base line after intervention and 4-6 months&#xD;
      after intervention finished.&#xD;
&#xD;
      All partners of this project will obtain approval for experiments on human subjects from&#xD;
      their local committees. Each subject (or parents/guardians for the participation of minor&#xD;
      subjects) will be able to sign an informed voluntary consent form, consistent with the&#xD;
      Helsinki Declaration, after reading a detailed explanation and having an oral Q/A session&#xD;
      with the investigator.&#xD;
&#xD;
      Recruitment: Prospective focused direct mailing or personal contacts will be initiated with&#xD;
      the parents/guardians of children with CP who are ambulatory, who had been seen by&#xD;
      physiotherapists in social groups and schools.&#xD;
&#xD;
      Inclusion exclusion criteria for Focus Groups:&#xD;
&#xD;
        -  30 adolescents with Cerebral Palsy&#xD;
&#xD;
        -  aged 14-25yrs&#xD;
&#xD;
        -  mobility level GMFCS I, II &amp; III and&#xD;
&#xD;
        -  20 Typically Developed individuals same age group&#xD;
&#xD;
        -  with verbal ability suitable for discussion&#xD;
&#xD;
        -  Cognitive level sufficient to comprehend and cooperate with measurements.&#xD;
&#xD;
        -  Parent or the individual (if above 18) has agreed to participate in the study&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Unstable medical situation&#xD;
&#xD;
        -  Progressive degenerative condition of the Central Nervous System (CNS) or&#xD;
           musculoskeletal system.&#xD;
&#xD;
      Inclusion exclusion criteria for intervention groups:&#xD;
&#xD;
        -  adolescents and young adults with bilateral spastic CP&#xD;
&#xD;
        -  at GMFCS level I, II and III&#xD;
&#xD;
        -  age 14-25 yrs&#xD;
&#xD;
        -  can speak their native language fluently&#xD;
&#xD;
        -  are able to follow verbal instructions&#xD;
&#xD;
        -  are willing to train in a group.&#xD;
&#xD;
      The exclusion criteria:&#xD;
&#xD;
      adolescents and young adults who had orthopedic surgery or tone reduction interventions (e.g.&#xD;
      botulinum toxin injections, history of baclofen pump or selective dorsal rhizotomy) within 6&#xD;
      months prior to this study&#xD;
&#xD;
      - have exercise induced asthma or cardiac problems.&#xD;
&#xD;
      Inclusion criteria for validation ASK &amp; Self Efficiency Questionnaire study:&#xD;
&#xD;
        -  30 Children and adolescents with CP&#xD;
&#xD;
        -  age 5-20yrs&#xD;
&#xD;
        -  GMFCS I;II;III.&#xD;
&#xD;
        -  Cognitive level sufficient to comprehend and cooperate with measurements.&#xD;
&#xD;
        -  Parent or the subject (if above 18) has agreed to participate in the study&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Unstable medical situation&#xD;
&#xD;
        -  Progressive degenerative condition of the CNS or musculoskeletal system&#xD;
&#xD;
      Outcome measurements:&#xD;
&#xD;
        1. Habitual Physical Activity (HPA).Physical activity is recorded using an &quot;ActivPAL3™&quot;&#xD;
           (PAL Technologies, Glasgow, UK) tri-axial accelerometer-based activity monitor.&#xD;
&#xD;
        2. 6 min walk test (6minWT): This test measures the self-paced distance in meters walked in&#xD;
           6 minutes on a flat, firm surface.&#xD;
&#xD;
        3. 10 meter walk test (10MWT): This self-paced test measures gait speed, important for safe&#xD;
           community mobility (e.g., crossing streets in response to signals).&#xD;
&#xD;
        4. Timed Up-and-Go (TUG): This test measures mobility for those able to walk on their own&#xD;
           (assistive device permitted).&#xD;
&#xD;
        5. Functional Mobility Scale (FMS): The FMS uses three distances (5, 50 and 500m) which&#xD;
           represent typical distances walked by children at home, at school, and in the wider&#xD;
           community.&#xD;
&#xD;
        6. The Activities Scale for Kids (ASK) is a child self-report measure of physical&#xD;
           disability. It is designed for children five to 15 years of age who are experiencing&#xD;
           limitations in physical activity due to musculoskeletal disorders.&#xD;
&#xD;
        7. The Pediatric Evaluation of Disability Inventory™ Computer Adaptive Test (PEDI-CAT)&#xD;
           measures abilities in the three functional domains of Daily Activities, Mobility and&#xD;
           Social/Cognitive. The PEDI-CAT's Responsibility domain measures the extent to which the&#xD;
           caregiver or child takes responsibility for managing complex, multi-step life tasks.&#xD;
&#xD;
        8. Self efficiency questionnaire: for evaluating perception of self efficiency for engaging&#xD;
           in physical activity and reducing sedentary behavior.&#xD;
&#xD;
      Statistics:&#xD;
&#xD;
      Focus group: Coding text and theorizing: In grounded theory research. Identifying anchors&#xD;
      that allow the key points of the data to be gathered. Collections of codes of similar content&#xD;
      that allows the data to be grouped.&#xD;
&#xD;
      Repeated measures analysis of variance (ANOVA) will be used to determine the effects and&#xD;
      compare the two groups methods.&#xD;
&#xD;
      A correlation test will take place between the ASK Capability and the PEDI-CAT. A correlation&#xD;
      test will take place between the ASK PERFORMANCE and the results from the accelerometers.&#xD;
&#xD;
      One-way ANOVA test by separation the sample to severity groups, according to the GMFCS&#xD;
      levels, using the age as a co-variant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>an ActivPAL3™ (PAL Technologies, Glasgow, UK) tri-axial accelerometer-based activity monitor.</measure>
    <time_frame>Measuring changes: Base line: time 1 before intervention. time 2: changes immediately after finish intervention. time 3: changes 6 months after time 2.</time_frame>
    <description>tri-axial accelerometer-based activity monitor. ActivePal accelerometer, is currently considered a reference method for discriminating sitting, standing, and ambulation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6minWT</measure>
    <time_frame>Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.</time_frame>
    <description>6 min walk test (6minWT): This test measures the self-paced distance in meters walked in 6 minutes on a flat, firm surface. This test assesses the sub-maximal level of functional capacity where most activities of daily living are performed and therefore reflects the effort required for daily physical activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>10MWT</measure>
    <time_frame>Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.</time_frame>
    <description>10 meter walk test (10MWT): This self-paced test measures gait speed, important for safe community mobility (e.g., crossing streets in response to signals). The 10MWT is measured by the time required to walk 10 m. It is a short and convenient test that can be applied to any subject able to ambulate that distance. A variation is the time to walk 10 m as fast as possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TUG</measure>
    <time_frame>Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.</time_frame>
    <description>Timed Up-and-Go (TUG): This test measures mobility for those able to walk on their own (assistive device permitted). The test includes standing up from a chair, walking 3 m, turning 180°, walking back to the chair and sitting down. The test is measured by the total time to complete the task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FMS</measure>
    <time_frame>Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.</time_frame>
    <description>Functional Mobility Scale (FMS): The FMS uses three distances (5, 50 and 500m) which represent typical distances walked by children at home, at school, and in the wider community. For each distance, a rating of 1 to 6 was assigned, depending on the amount of assistance required for mobility. The rating is performed according to child/parent report of what the child does and is not by clinical observation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ASK</measure>
    <time_frame>Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.</time_frame>
    <description>The Activities Scale for Kids is a child self-report measure of physical disability. It is designed for children five to 15 years of age who are experiencing limitations in physical activity due to musculoskeletal disorders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEDI-CAT</measure>
    <time_frame>Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention, 4 months after starting intervention.</time_frame>
    <description>The PEDI-CAT measures abilities in the three functional domains of Daily Activities, Mobility and Social/Cognitive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self efficiency questionnaire</measure>
    <time_frame>Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. 4 months after starting intervention.</time_frame>
    <description>Physical activity and sedentary behavior self efficiency questionnaire. include 17 facets 4 choices of agreements with statements.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Cerebral Palsy (CP)</condition>
  <arm_group>
    <arm_group_label>Life style changing: reducing sedentary behavior</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Meetings with social worker and physical therapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Physical therapy exercise training in group, strengthening and stretching muscles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Life style changing: reducing sedentary behavior</intervention_name>
    <description>The program includes 23 meetings held once per week (with holiday breaks). Each meeting lasts 90 minutes, consisting of exercise training.&#xD;
the group will meet for information providing and discussion. Participants are guided in the process of creating a focussed individualized activity plan.&#xD;
In the group setting they will experience a variety of activities enabling them to explore activities they prefer: each participant receive three personal consultation meetings. The group will experience sport and recreational activities with persons with physical impairments. Also activities in sport in community facilities.</description>
    <arm_group_label>Life style changing: reducing sedentary behavior</arm_group_label>
    <arm_group_label>Physical exercise group</arm_group_label>
    <other_name>0082-15-ASF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Intervention group:&#xD;
&#xD;
          -  children, adolescents and young adults age 14-25 yrs&#xD;
&#xD;
          -  with bilateral spastic Cerebral Palsy&#xD;
&#xD;
          -  at GMFCS level I, II and III&#xD;
&#xD;
          -  can speak their native language fluently&#xD;
&#xD;
          -  able to follow verbal instructions&#xD;
&#xD;
          -  willing to train in a group.&#xD;
&#xD;
        For ASK: age 5-18yrs.&#xD;
&#xD;
          -  children, adolescents and young adults age 5-18yrs&#xD;
&#xD;
          -  with bilateral spastic Cerebral Palsy&#xD;
&#xD;
          -  at GMFCS level I, II and III&#xD;
&#xD;
          -  can speak their native language&#xD;
&#xD;
          -  able to follow verbal instructions&#xD;
&#xD;
        The exclusion criteria:&#xD;
&#xD;
          -  Individual who had orthopedic surgery or tone reduction interventions (e.g. botulinum&#xD;
             toxin injections, or have a history of baclofen pump or selective dorsal rhizotomy&#xD;
             within 6 months prior to this study&#xD;
&#xD;
          -  have exercise induced asthma or cardiac problems.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leonel Copeliovitch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Human Motion Analysis Laboratory, Assaf Harofe Medical Center Zerifin Israel</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>December 4, 2016</last_update_submitted>
  <last_update_submitted_qc>December 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Habitual Physical Activity (HPA); Sedentary Behavior;</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>


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/NCT02978469
org study id: 0082-15-ASF
nct id: NCT02978469
lead sponsor: 
has dmc: Yes
Long hours of daily sitting and lack of Physical Activity (PA) are risk factors for morbidity
      and mortality.

      People with movement disabilities, including adolescents with Cerebral Palsy (CP) tend to
      lead a sedentary life styl and have have poor physical fitness. Adolescents with CP where
      found to be inactive most of the day thus, they are in greater risk of disease than the
      general population. In addition, over the years, people with disabilities experience physical
      and functional deterioration. Reducing sedentary behavior and increasing daily activity can
      reduce health risk factors among the adolescents with CP, reduce secondary impairments and
      preserve function.

      Interventions that included exercise alone has not resulted in physical activity and
      participating in a structured training did not continue after cessation intervention.

      The objectives of this study are to establish effective programs aiming to promote an active
      life style among adolescents and young adults with CP and to evaluate there outcomes.

      Specific objectives- Stage 1- Identifying barriers and facilitators for reducing sedentary
      behaviors and increasing physical activity among adolescents and young adults with CP. As
      well as, identifying mediators, needs and preferences for reducing sedentary behaviors and
      increasing physical activity among adolescents and young adults with CP.

      Stage 2- Based on stage 1- Establishing an intervention for reducing sedentary behaviors and
      increasing physical activity among adolescents.

      Stage 3- translating and developing questioners for the study.

        -  Translating the ASK-Performance and the ASK-Capability questionnaires to Hebrew and
           validating the Hebrew translation.

        -  Developing a self-efficacy perception questioner for increasing physical activity and
           reducing and sedentary behavior.

        -  Translating to Hebrew, adjusting and validating an activity diary.

      Stage 4- evaluating the effectiveness of the proposed intervention program on reducing
      sedentary behaviors and increasing physical activity among adolescents and young adults with
      CP.
Stage 1 focus group- Identifying barriers and facilitators for reducing sedentary behaviors
      and increasing physical activity as well as, identifying mediators, needs and preferences for
      reducing sedentary behaviors and increasing physical activity.

      Stage 2- Based on stage 1- Establishing an intervention for reducing sedentary behaviors and
      increasing physical activity among adolescents. The intervention group will receive
      behavior-modification in group. The control group will get physical exercises.Stage 3-
      translating and developing questioners for the study.

        -  Translating the ASK-Performance and the ASK-Capability questionnaires to Hebrew and
           validating the Hebrew translation.

        -  Developing a self-efficacy perception questioner for increasing physical activity and
           reducing and sedentary behavior.

        -  Translating to Hebrew, adjusting and validating an activity diary.

      Stage 4- evaluating the effectiveness of the proposed intervention program on reducing
      sedentary behaviors and increasing physical activity among adolescents and young adults with
      CP. The outcome measures will measure change from base line after intervention and 4-6 months
      after intervention finished.

      All partners of this project will obtain approval for experiments on human subjects from
      their local committees. Each subject (or parents/guardians for the participation of minor
      subjects) will be able to sign an informed voluntary consent form, consistent with the
      Helsinki Declaration, after reading a detailed explanation and having an oral Q/A session
      with the investigator.

      Recruitment: Prospective focused direct mailing or personal contacts will be initiated with
      the parents/guardians of children with CP who are ambulatory, who had been seen by
      physiotherapists in social groups and schools.

      Inclusion exclusion criteria for Focus Groups:

        -  30 adolescents with Cerebral Palsy

        -  aged 14-25yrs

        -  mobility level GMFCS I, II & III and

        -  20 Typically Developed individuals same age group

        -  with verbal ability suitable for discussion

        -  Cognitive level sufficient to comprehend and cooperate with measurements.

        -  Parent or the individual (if above 18) has agreed to participate in the study

      Exclusion criteria:

        -  Unstable medical situation

        -  Progressive degenerative condition of the Central Nervous System (CNS) or
           musculoskeletal system.

      Inclusion exclusion criteria for intervention groups:

        -  adolescents and young adults with bilateral spastic CP

        -  at GMFCS level I, II and III

        -  age 14-25 yrs

        -  can speak their native language fluently

        -  are able to follow verbal instructions

        -  are willing to train in a group.

      The exclusion criteria:

      adolescents and young adults who had orthopedic surgery or tone reduction interventions (e.g.
      botulinum toxin injections, history of baclofen pump or selective dorsal rhizotomy) within 6
      months prior to this study

      - have exercise induced asthma or cardiac problems.

      Inclusion criteria for validation ASK & Self Efficiency Questionnaire study:

        -  30 Children and adolescents with CP

        -  age 5-20yrs

        -  GMFCS I;II;III.

        -  Cognitive level sufficient to comprehend and cooperate with measurements.

        -  Parent or the subject (if above 18) has agreed to participate in the study

      Exclusion criteria:

        -  Unstable medical situation

        -  Progressive degenerative condition of the CNS or musculoskeletal system

      Outcome measurements:

        1. Habitual Physical Activity (HPA).Physical activity is recorded using an "ActivPAL3™"
           (PAL Technologies, Glasgow, UK) tri-axial accelerometer-based activity monitor.

        2. 6 min walk test (6minWT): This test measures the self-paced distance in meters walked in
           6 minutes on a flat, firm surface.

        3. 10 meter walk test (10MWT): This self-paced test measures gait speed, important for safe
           community mobility (e.g., crossing streets in response to signals).

        4. Timed Up-and-Go (TUG): This test measures mobility for those able to walk on their own
           (assistive device permitted).

        5. Functional Mobility Scale (FMS): The FMS uses three distances (5, 50 and 500m) which
           represent typical distances walked by children at home, at school, and in the wider
           community.

        6. The Activities Scale for Kids (ASK) is a child self-report measure of physical
           disability. It is designed for children five to 15 years of age who are experiencing
           limitations in physical activity due to musculoskeletal disorders.

        7. The Pediatric Evaluation of Disability Inventory™ Computer Adaptive Test (PEDI-CAT)
           measures abilities in the three functional domains of Daily Activities, Mobility and
           Social/Cognitive. The PEDI-CAT's Responsibility domain measures the extent to which the
           caregiver or child takes responsibility for managing complex, multi-step life tasks.

        8. Self efficiency questionnaire: for evaluating perception of self efficiency for engaging
           in physical activity and reducing sedentary behavior.

      Statistics:

      Focus group: Coding text and theorizing: In grounded theory research. Identifying anchors
      that allow the key points of the data to be gathered. Collections of codes of similar content
      that allows the data to be grouped.

      Repeated measures analysis of variance (ANOVA) will be used to determine the effects and
      compare the two groups methods.

      A correlation test will take place between the ASK Capability and the PEDI-CAT. A correlation
      test will take place between the ASK PERFORMANCE and the results from the accelerometers.

      One-way ANOVA test by separation the sample to severity groups, according to the GMFCS
      levels, using the age as a co-variant.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: an ActivPAL3™ (PAL Technologies, Glasgow, UK) tri-axial accelerometer-based activity monitor.
time frame: Measuring changes: Base line: time 1 before intervention. time 2: changes immediately after finish intervention. time 3: changes 6 months after time 2.
description: tri-axial accelerometer-based activity monitor. ActivePal accelerometer, is currently considered a reference method for discriminating sitting, standing, and ambulation.
measure: 6minWT
time frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.
description: 6 min walk test (6minWT): This test measures the self-paced distance in meters walked in 6 minutes on a flat, firm surface. This test assesses the sub-maximal level of functional capacity where most activities of daily living are performed and therefore reflects the effort required for daily physical activities.
measure: 10MWT
time frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.
description: 10 meter walk test (10MWT): This self-paced test measures gait speed, important for safe community mobility (e.g., crossing streets in response to signals). The 10MWT is measured by the time required to walk 10 m. It is a short and convenient test that can be applied to any subject able to ambulate that distance. A variation is the time to walk 10 m as fast as possible.
measure: TUG
time frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.
description: Timed Up-and-Go (TUG): This test measures mobility for those able to walk on their own (assistive device permitted). The test includes standing up from a chair, walking 3 m, turning 180°, walking back to the chair and sitting down. The test is measured by the total time to complete the task.
measure: FMS
time frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.
description: Functional Mobility Scale (FMS): The FMS uses three distances (5, 50 and 500m) which represent typical distances walked by children at home, at school, and in the wider community. For each distance, a rating of 1 to 6 was assigned, depending on the amount of assistance required for mobility. The rating is performed according to child/parent report of what the child does and is not by clinical observation.
measure: ASK
time frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.
description: The Activities Scale for Kids is a child self-report measure of physical disability. It is designed for children five to 15 years of age who are experiencing limitations in physical activity due to musculoskeletal disorders.
measure: PEDI-CAT
time frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention, 4 months after starting intervention.
description: The PEDI-CAT measures abilities in the three functional domains of Daily Activities, Mobility and Social/Cognitive.
measure: Self efficiency questionnaire
time frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. 4 months after starting intervention.
description: Physical activity and sedentary behavior self efficiency questionnaire. include 17 facets 4 choices of agreements with statements.
arm group label: Life style changing: reducing sedentary behavior
arm group type: Experimental
description: Meetings with social worker and physical therapist.
arm group label: Physical exercise group
arm group type: Active Comparator
description: Physical therapy exercise training in group, strengthening and stretching muscles.
intervention type: Other
intervention name: Life style changing: reducing sedentary behavior
description: The program includes 23 meetings held once per week (with holiday breaks). Each meeting lasts 90 minutes, consisting of exercise training.
the group will meet for information providing and discussion. Participants are guided in the process of creating a focussed individualized activity plan.
In the group setting they will experience a variety of activities enabling them to explore activities they prefer: each participant receive three personal consultation meetings. The group will experience sport and recreational activities with persons with physical impairments. Also activities in sport in community facilities.
arm group label: Life style changing: reducing sedentary behavior
arm group label: Physical exercise group
other name: 0082-15-ASF
criteria: 
gender: All
minimum age: 5 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leonel Copeliovitch, MD
role: Principal Investigator
affiliation: Human Motion Analysis Laboratory, Assaf Harofe Medical Center Zerifin Israel
responsible party type: Sponsor
mesh term: Cerebral Palsy
sharing ipd: No