<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/NCT03264339</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1366</org_study_id>
    <nct_id>NCT03264339</nct_id>
  </id_info>
  <brief_title>The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy</brief_title>
  <official_title>The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Olavs Hospital</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>
      Children with cerebral palsy (CP) have life-long motor disorders caused by brain injuries&#xD;
      which occur around birth. These children go through extensive treatment during childhood, but&#xD;
      the treatment has generally been started late due to late diagnosis (median age 15 months).&#xD;
      New recommendations state that the clinical diagnosis &quot;high risk of CP&quot; should be given&#xD;
      before 6 months corrected age, in order to be able to intervene as early as possible, and&#xD;
      have the best possibilities to prevent or limit the adverse neurodevelopmental consequences&#xD;
      of brain injuries occurring around birth. Thus, there is a great need to develop&#xD;
      evidence-based early interventions for children at high risk of developing cerebral palsy.&#xD;
&#xD;
      The Small Step program is developed at Karolinska Institutet (KI) in Stockholm, Sweden and is&#xD;
      based upon theories of brain plasticity induced by early learning. The efficacy of the&#xD;
      program is presently being investigated at KI. Preliminary results indicate a large&#xD;
      individual variation in response to the program among the participating children.&#xD;
&#xD;
      The aim of the present study is therefore to explore individual responses to the Small Step&#xD;
      Program in infants at risk of developing cerebral palsy.&#xD;
&#xD;
      The main hypothesis is that infant characteristics, such as severity of brain pathology, are&#xD;
      associated with differential response to the program. Also, infants with absent fidgety&#xD;
      movements and children with sporadic fidgety movements are believed to respond differently to&#xD;
      the program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The efficacy of the Small Step program is presently being investigated through a randomized&#xD;
      controlled trial (NCT02166801) at Karolinska Institutet (KI) in Stockholm, Sweden. In the&#xD;
      original project proposal for the current study, the plan was to contribute with inclusion of&#xD;
      children from St. Olavs Hospital to the randomized controlled study initiated at KI. This&#xD;
      project proposal has previously been approved by the Regional Ethical Committee (REK) for&#xD;
      Medical Research in Mid-Norway (2016/1366). However, the researchers at KI have now completed&#xD;
      the inclusion of participants for the randomized controlled study, and their preliminary&#xD;
      results indicate that there is a large individual variation among the included participants&#xD;
      regarding effect of the Small Step program. In agreement with the researchers at KI, it was&#xD;
      therefore decided to change the design of the current study using Single Subject Research&#xD;
      Design, a study design that is more appropriate to investigate individual response to&#xD;
      treatment. The change in study design has been approved by REK (2016/1366-10).&#xD;
&#xD;
      Participation in this study is based on informed consent from the parents, and the child and&#xD;
      the family participating in the project will be offered a potentially effective early&#xD;
      intervention program that they would otherwise not be able to access.&#xD;
&#xD;
      The Small Step intervention program has three alternating treatment foci (B, C, and D)&#xD;
      divided into five different steps, each lasting for 6 weeks (in total 30 weeks). The three&#xD;
      treatment foci are Communication, Hand function and Mobility/gross motor function. The Hand&#xD;
      function and Mobility steps will be conducted during two time-periods and the order will be&#xD;
      randomised. Communication will have one intervention period during step III. The training&#xD;
      will be conducted in the children's home by the parents on a daily basis under weekly&#xD;
      supervision by the therapist responsible for each specific step of the intervention. General&#xD;
      principles for the small step program are: a) collaborative goal-setting; b) promote infant's&#xD;
      self-initiated actions; c) use of enriched home environment, d) intensity and repetition.&#xD;
&#xD;
      Before and after the intervention, there is a baseline phase with no treatment (A) and a&#xD;
      withdrawal phase with no treatment (A), resulting in the following design: A-B-C-D-B-C-A. In&#xD;
      addition, there is a follow-up phase when the children are 2 years of age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">June 7, 2021</completion_date>
  <primary_completion_date type="Actual">June 7, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single-subject research design (SSRD) will be used with each participant serving as his/her own control.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peabody Developmental Motor Scales, second edition (PDMS-2)</measure>
    <time_frame>up to 2 years</time_frame>
    <description>PDMS-2 is a standard measurement that assesses gross and fine motor skills in young children from birth through age 5 years. The PDMS-2 is composed of six subtests that assess related motor abilities that develop early in life. In this study, the Stationary, Locomotion, Grasping, and Visual-Motor Integration subtests will be used. The scores on these subtests are presented as percentiles, standard scores, and age equivalents.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hand Assessment for Infants (HAI)</measure>
    <time_frame>up to 2 years</time_frame>
    <description>identifies and measures upper limb asymmetry and general manual development from 3-12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alberta Infant Motor Scale (AIMS)</measure>
    <time_frame>up to 2 years</time_frame>
    <description>identifies infants with delayed or deviant motor development up to 18 months of age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gross Motor Function Measure (GMFM-66)</measure>
    <time_frame>up to 2 years</time_frame>
    <description>an observational, standardized and criterion-referenced measure, developed to evaluate change in gross motor function in children with cerebral palsy (CP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-Child Early Relational Assessment (PC-ERA)</measure>
    <time_frame>up to 2 years</time_frame>
    <description>assesses parent-child interactions to capture the affective and behavioral characteristics that parent and child bring to the interaction, and the quality or tone of the relationship</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Expectancy and Credibility Survey (TCS) - modification</measure>
    <time_frame>up to 2 years</time_frame>
    <description>assesses treatment expectations</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hammersmith Infant Neurological Examination (HINE)</measure>
    <time_frame>at baseline, after the intervention at 30 weeks and at follow-up up at 2 years</time_frame>
    <description>Identifies neurological signs in infants and is used to estimate the neurological development of infants aged two-24 months</description>
  </other_outcome>
  <other_outcome>
    <measure>The Working Model of the Child Interview (WMCI)</measure>
    <time_frame>at baseline, after the intervention at 30 weeks and at follow-up up at 2 years</time_frame>
    <description>a semi-structured, open-ended interview designed to assess parent´s representations of their infant/ child and their relationship with their infant/ child. The WMCI will be used to measure change over time</description>
  </other_outcome>
  <other_outcome>
    <measure>The Ages &amp; Stages Questionnaire: Social and Emotional (ASQ:SE)</measure>
    <time_frame>at baseline, after the intervention at 30 weeks and at follow-up up at 2 years</time_frame>
    <description>a questionnaire to be completed by parents for assessing social and emotional difficulties in babies and young children</description>
  </other_outcome>
  <other_outcome>
    <measure>Norwegian Parenting Stress Index (PSI)</measure>
    <time_frame>at baseline, after the intervention at 30 weeks and at follow-up up at 2 years</time_frame>
    <description>used to measure changes in perceived parental stress over time</description>
  </other_outcome>
  <other_outcome>
    <measure>The Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>at baseline, after the intervention at 30 weeks and at follow-up up at 2 years</time_frame>
    <description>a self-assessment scale for parents and is used to detect changes in states of depression, anxiety and emotional distress over time among parents</description>
  </other_outcome>
  <other_outcome>
    <measure>Pediatric Evaluation of the Disability Inventory (PEDI)</measure>
    <time_frame>at 2 years</time_frame>
    <description>used to evaluate functional skills and caregiver assistance in the domains self-care, mobility, and social function over time. The child is assessed by structured interviews with the parents. The summary scores can be converted to normative standard scores and scaled scores, meaning that the child's performance will be compared with norms taken from typically developing children</description>
  </other_outcome>
  <other_outcome>
    <measure>Bayley Scales of Infant Development (BSID-III)</measure>
    <time_frame>at 2 years</time_frame>
    <description>a standard measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers, ages 0-3. These scores will be used to determine the child's performance at two years of age compared with norms taken from typically developing children</description>
  </other_outcome>
  <other_outcome>
    <measure>Norwegian Communicative Development Inventory (NCDI)</measure>
    <time_frame>at 2 years</time_frame>
    <description>a parent questionnaire for assessing early language development of children. The NCDI involve questions about communication and language capacities corresponding to the child's ability to comprehend and use communication and language and will be collected</description>
  </other_outcome>
  <other_outcome>
    <measure>Structural magnetic resonance imaging (MRI)/cerebral ultrasound</measure>
    <time_frame>before 2 years corrected age</time_frame>
    <description>used to identify neuroanatomical abnormalities and underlying brain lesions. Neuroimaging data will be assessed by experienced neuroradiologists in accordance with well-established clinical assessment protocols at the hospital. This means that the children included in the project will not undergo any extra structural MRI examinations outside the normal clinical routine.</description>
  </other_outcome>
  <other_outcome>
    <measure>General Movements Assessment (GMA)</measure>
    <time_frame>at 3 months corrected age</time_frame>
    <description>identifies reduced movement quality (i.e. absent or sporadic fidgety movements) in infants at 3 months corrected age. The GMA is part of the clinical assessment performed at the hospital and is assessed by certified and experienced physiotherapists</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Smal step</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Small Step Program, comprising 3 treatment focus areas (Hand use, Mobility, Communication)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Small Step Program</intervention_name>
    <description>The Small Step intervention program has three alternating treatment foci (Hand use, Mobility, Communication) divided into five different steps, each lasting for 6 weeks (in total 30 weeks).</description>
    <arm_group_label>Smal step</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  increased perinatal risk factors, such as preterm birth, hypoxic ischemic&#xD;
             encephalopathy (asphyxia), and morphological brain abnormalities. These &quot;at-risk&quot;&#xD;
             children are included in the regular clinical follow-up program at St. Olavs&#xD;
             University Hospital comprising a standard examination at 3 months of age (for preterm&#xD;
             born children: 3 months post term, so-called corrected age). At this examination,&#xD;
             infants who exhibit two or more of the following additional risk factors will be&#xD;
             eligible for study participation:&#xD;
&#xD;
               -  Neurological signs assessed with Hammersmith Infant Neurological Examination&#xD;
                  (HINE) with a cut-off score of &lt; 57 (20).&#xD;
&#xD;
               -  Delayed psycho-motor development measured with Alberta Infant Motor Scale (AIMS)&#xD;
                  using 2SD as the cut-off.&#xD;
&#xD;
               -  Absent or sporadic fidgety movements assessed with the General Movements&#xD;
                  Assessment (GMA)&#xD;
&#xD;
               -  Pathological findings on cerebral imaging (magnetic resonance&#xD;
                  imaging-MRI/cerebral ultrasound) done in regular clinical practice.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable medical condition&#xD;
&#xD;
          -  progressive disorders&#xD;
&#xD;
          -  diagnosis with a specific syndrome.&#xD;
&#xD;
          -  neither parent is fluent in Norwegian or English. Satisfactory skills in either&#xD;
             language are required for participation in data collection and the coaching and&#xD;
             education program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>8 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisabeth Selvaag, md</last_name>
    <role>Study Director</role>
    <affiliation>St Olavs Hospital, Children's Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Eliasson AC, Holmstrom L, Aarne P, Nakeva von Mentzer C, Weiland AL, Sjostrand L, Forssberg H, Tedroff K, Lowing K. Efficacy of the small step program in a randomised controlled trial for infants below age 12 months with clinical signs of CP; a study protocol. BMC Pediatr. 2016 Nov 3;16(1):175. doi: 10.1186/s12887-016-0711-x.</citation>
    <PMID>27809886</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infant</keyword>
  <keyword>Hand/Growth &amp; Development</keyword>
  <keyword>Motor activity</keyword>
  <keyword>Exercise</keyword>
  <keyword>Communication</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>Yes</sharing_ipd>
    <ipd_description>(in progress)</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/NCT03264339
org study id: 2016/1366
nct id: NCT03264339
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Children with cerebral palsy (CP) have life-long motor disorders caused by brain injuries
      which occur around birth. These children go through extensive treatment during childhood, but
      the treatment has generally been started late due to late diagnosis (median age 15 months).
      New recommendations state that the clinical diagnosis "high risk of CP" should be given
      before 6 months corrected age, in order to be able to intervene as early as possible, and
      have the best possibilities to prevent or limit the adverse neurodevelopmental consequences
      of brain injuries occurring around birth. Thus, there is a great need to develop
      evidence-based early interventions for children at high risk of developing cerebral palsy.

      The Small Step program is developed at Karolinska Institutet (KI) in Stockholm, Sweden and is
      based upon theories of brain plasticity induced by early learning. The efficacy of the
      program is presently being investigated at KI. Preliminary results indicate a large
      individual variation in response to the program among the participating children.

      The aim of the present study is therefore to explore individual responses to the Small Step
      Program in infants at risk of developing cerebral palsy.

      The main hypothesis is that infant characteristics, such as severity of brain pathology, are
      associated with differential response to the program. Also, infants with absent fidgety
      movements and children with sporadic fidgety movements are believed to respond differently to
      the program.
The efficacy of the Small Step program is presently being investigated through a randomized
      controlled trial (NCT02166801) at Karolinska Institutet (KI) in Stockholm, Sweden. In the
      original project proposal for the current study, the plan was to contribute with inclusion of
      children from St. Olavs Hospital to the randomized controlled study initiated at KI. This
      project proposal has previously been approved by the Regional Ethical Committee (REK) for
      Medical Research in Mid-Norway (2016/1366). However, the researchers at KI have now completed
      the inclusion of participants for the randomized controlled study, and their preliminary
      results indicate that there is a large individual variation among the included participants
      regarding effect of the Small Step program. In agreement with the researchers at KI, it was
      therefore decided to change the design of the current study using Single Subject Research
      Design, a study design that is more appropriate to investigate individual response to
      treatment. The change in study design has been approved by REK (2016/1366-10).

      Participation in this study is based on informed consent from the parents, and the child and
      the family participating in the project will be offered a potentially effective early
      intervention program that they would otherwise not be able to access.

      The Small Step intervention program has three alternating treatment foci (B, C, and D)
      divided into five different steps, each lasting for 6 weeks (in total 30 weeks). The three
      treatment foci are Communication, Hand function and Mobility/gross motor function. The Hand
      function and Mobility steps will be conducted during two time-periods and the order will be
      randomised. Communication will have one intervention period during step III. The training
      will be conducted in the children's home by the parents on a daily basis under weekly
      supervision by the therapist responsible for each specific step of the intervention. General
      principles for the small step program are: a) collaborative goal-setting; b) promote infant's
      self-initiated actions; c) use of enriched home environment, d) intensity and repetition.

      Before and after the intervention, there is a baseline phase with no treatment (A) and a
      withdrawal phase with no treatment (A), resulting in the following design: A-B-C-D-B-C-A. In
      addition, there is a follow-up phase when the children are 2 years of age.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single-subject research design (SSRD) will be used with each participant serving as his/her own control.
primary purpose: Treatment
masking: None (Open Label)
measure: Peabody Developmental Motor Scales, second edition (PDMS-2)
time frame: up to 2 years
description: PDMS-2 is a standard measurement that assesses gross and fine motor skills in young children from birth through age 5 years. The PDMS-2 is composed of six subtests that assess related motor abilities that develop early in life. In this study, the Stationary, Locomotion, Grasping, and Visual-Motor Integration subtests will be used. The scores on these subtests are presented as percentiles, standard scores, and age equivalents.
measure: Hand Assessment for Infants (HAI)
time frame: up to 2 years
description: identifies and measures upper limb asymmetry and general manual development from 3-12 months
measure: Alberta Infant Motor Scale (AIMS)
time frame: up to 2 years
description: identifies infants with delayed or deviant motor development up to 18 months of age
measure: Gross Motor Function Measure (GMFM-66)
time frame: up to 2 years
description: an observational, standardized and criterion-referenced measure, developed to evaluate change in gross motor function in children with cerebral palsy (CP)
measure: Parent-Child Early Relational Assessment (PC-ERA)
time frame: up to 2 years
description: assesses parent-child interactions to capture the affective and behavioral characteristics that parent and child bring to the interaction, and the quality or tone of the relationship
measure: Treatment Expectancy and Credibility Survey (TCS) - modification
time frame: up to 2 years
description: assesses treatment expectations
measure: Hammersmith Infant Neurological Examination (HINE)
time frame: at baseline, after the intervention at 30 weeks and at follow-up up at 2 years
description: Identifies neurological signs in infants and is used to estimate the neurological development of infants aged two-24 months
measure: The Working Model of the Child Interview (WMCI)
time frame: at baseline, after the intervention at 30 weeks and at follow-up up at 2 years
description: a semi-structured, open-ended interview designed to assess parent´s representations of their infant/ child and their relationship with their infant/ child. The WMCI will be used to measure change over time
measure: The Ages & Stages Questionnaire: Social and Emotional (ASQ:SE)
time frame: at baseline, after the intervention at 30 weeks and at follow-up up at 2 years
description: a questionnaire to be completed by parents for assessing social and emotional difficulties in babies and young children
measure: Norwegian Parenting Stress Index (PSI)
time frame: at baseline, after the intervention at 30 weeks and at follow-up up at 2 years
description: used to measure changes in perceived parental stress over time
measure: The Hospital Anxiety and Depression Scale (HADS)
time frame: at baseline, after the intervention at 30 weeks and at follow-up up at 2 years
description: a self-assessment scale for parents and is used to detect changes in states of depression, anxiety and emotional distress over time among parents
measure: Pediatric Evaluation of the Disability Inventory (PEDI)
time frame: at 2 years
description: used to evaluate functional skills and caregiver assistance in the domains self-care, mobility, and social function over time. The child is assessed by structured interviews with the parents. The summary scores can be converted to normative standard scores and scaled scores, meaning that the child's performance will be compared with norms taken from typically developing children
measure: Bayley Scales of Infant Development (BSID-III)
time frame: at 2 years
description: a standard measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers, ages 0-3. These scores will be used to determine the child's performance at two years of age compared with norms taken from typically developing children
measure: Norwegian Communicative Development Inventory (NCDI)
time frame: at 2 years
description: a parent questionnaire for assessing early language development of children. The NCDI involve questions about communication and language capacities corresponding to the child's ability to comprehend and use communication and language and will be collected
measure: Structural magnetic resonance imaging (MRI)/cerebral ultrasound
time frame: before 2 years corrected age
description: used to identify neuroanatomical abnormalities and underlying brain lesions. Neuroimaging data will be assessed by experienced neuroradiologists in accordance with well-established clinical assessment protocols at the hospital. This means that the children included in the project will not undergo any extra structural MRI examinations outside the normal clinical routine.
measure: General Movements Assessment (GMA)
time frame: at 3 months corrected age
description: identifies reduced movement quality (i.e. absent or sporadic fidgety movements) in infants at 3 months corrected age. The GMA is part of the clinical assessment performed at the hospital and is assessed by certified and experienced physiotherapists
arm group label: Smal step
arm group type: Experimental
description: Small Step Program, comprising 3 treatment focus areas (Hand use, Mobility, Communication)
intervention type: Behavioral
intervention name: Small Step Program
description: The Small Step intervention program has three alternating treatment foci (Hand use, Mobility, Communication) divided into five different steps, each lasting for 6 weeks (in total 30 weeks).
arm group label: Smal step
criteria: 
gender: All
minimum age: 3 Months
maximum age: 8 Months
healthy volunteers: No
last name: Elisabeth Selvaag, md
role: Study Director
affiliation: St Olavs Hospital, Children's Clinic
facility: 
country: Norway
citation: Eliasson AC, Holmstrom L, Aarne P, Nakeva von Mentzer C, Weiland AL, Sjostrand L, Forssberg H, Tedroff K, Lowing K. Efficacy of the small step program in a randomised controlled trial for infants below age 12 months with clinical signs of CP; a study protocol. BMC Pediatr. 2016 Nov 3;16(1):175. doi: 10.1186/s12887-016-0711-x.
PMID: 27809886
responsible party type: Sponsor
mesh term: Cerebral Palsy
sharing ipd: Yes
ipd description: (in progress)