Hydrocephalus iPad-App Based Intervention Study

NCT ID: NCT03595033

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-24
• Study Completion Date: 2018-12-28

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.

Conditions

Hydrocephalus; Hydrocephaly; Hydrocephalus in Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Phase

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.

Group Type: EXPERIMENTAL

iPad app-based intervention

Intervention Type: DEVICE

The 1-hour of home based intervention will break into three 20-min sessions, each including iPad apps targeting one of the three domains of deficits: visual attention, visual-spatial reasoning, and visual-motor skills.

Interventions

iPad app-based intervention

The 1-hour of home based intervention will break into three 20-min sessions, each including iPad apps targeting one of the three domains of deficits: visual attention, visual-spatial reasoning, and visual-motor skills.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen L Harpster, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Other Identifiers

CIN_HCPiPad_001

Identifier Type: -

Identifier Source: org_study_id