Hydrocephalus iPad-App Based Intervention Study

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Brief Title

Hydrocephalus iPad-App Based Intervention Study

Official Title

iPad Application Based Therapy Intervention in School Age Children With Surgically Treated Hydrocephalus

Brief Summary

      This is a pilot study examining the feasibility and efficacy of using Apple iPad applications
      ("apps") during therapy interventions that target visual motor, visual attention, and
      visual-spatial reasoning skills in school age children who were previously treated surgically
      for hydrocephalus. Each subject will participate in an initial assessment and baseline MRI,
      followed by 6-weeks of iPad app-based interventions, and finally a follow-up assessment and a
      follow-up MRI.
    

Detailed Description

      Long term visuospatial and visuomotor functional deficits are common in pediatric patients
      with surgically treated hydrocephalus. The deficits are often mild/moderate at early school
      age although the gap may widen as the children grow older, leading to increasing adverse
      impact on school performance and academic achievement. The proposed study will generate
      initial pilot data for the usage of iPad application based therapy intervention for the
      treatment of cognitive deficits common to pediatric hydrocephalus. It will help determine the
      optimal intensity and duration of training protocol adapted for the study. In addition, the
      sensitivity of neuroimaging (DTI) in response to the therapy will be assessed and validated
      as a biomarker that reflects the neuroanatomical alterations underpinning the outcome
      changes. This study will generate the crucial data to support the design of future Phase III
      clinical trial with the long term goal as changing the current standard of care in order to
      prevent neurocognitive and sensorimotor deficits before the injury to neural circuitry
      becomes irreversible.

      The participants who meet the inclusion criteria and do not opt-out of participation will be
      called by a study coordinator to ensure eligibility and to schedule the initial assessment
      date. Participation in this study will include 8-10 study visits. These visits include 2
      neuropsychological assessments, 2 MRI visits, and 6 weekly visits during intervention phase.
      MRI visit can be combined with the neuropsychological assessment visit if possible at both
      the pre- and post intervention time points.
    


Study Type

Interventional


Primary Outcome

General intellectual functioning, including visual-spatial reasoning

Secondary Outcome

 Adherence to the training plan

Condition

Hydrocephalus

Intervention

iPad app-based intervention

Study Arms / Comparison Groups

 Intervention Phase
Description:  Throughout the intervention phase, participants will attend weekly intervention visits. During these visits, an occupational therapist (OT) will educate the participant and their caregiver on the therapy plan which includes the iPad apps to be completed during the week. The participants will be asked to complete their therapy plan for 1 hour per day at home, 4 days per week.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

14

Start Date

November 24, 2015

Completion Date

December 28, 2018

Primary Completion Date

December 28, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Children, aged 6 to 17 years, with hydrocephalus who have had a surgical intervention

          -  Deficits in 2 of more of the following neuropsychological testing categories: visual
             motor, visual attention, or visual reasoning.

        Exclusion Criteria:

          -  Shunt revision within the past one year

          -  MRI-sensitive programmable shunt or any other MRI-sensitive implant

          -  Braces or other dental hardware that would interfere with the quality of MRI images
             (participants with braces are only excluded from the MRI portion of the study)

          -  Intellectual disability: IQ < 70

          -  Deficits in one or none of the three following neuropsychological testing categories:
             visual motor, visual attention, or visual reasoning

          -  Age 18 years or greater

          -  Non-English speaking: We will not enroll non-English speaking participants because the
             iPad applications are not readily available in other languages. All neuropsychological
             testing materials are also in English.
      

Gender

All

Ages

6 Years - 6 Years

Accepts Healthy Volunteers

No

Contacts

Karen L Harpster, PhD, OTR/L, , 



Administrative Informations


NCT ID

NCT03595033

Organization ID

CIN_HCPiPad_001


Responsible Party

Sponsor

Study Sponsor

Children's Hospital Medical Center, Cincinnati


Study Sponsor

Karen L Harpster, PhD, OTR/L, Principal Investigator, Children's Hospital Medical Center, Cincinnati


Verification Date

February 2021